contmurtion pace emeetaterrever ore otson, staphen c ‘Ya. ae 310% Frome. 39.10% H.10% : Fram 33.10% a0 ‘GRADUATEIPROFESSIONAL TRANG STUDENTS Fringe Rates: Fringe varies by individual based on prcent of tine appointed andthe number of credis, ‘PERSONNEL JUSTICATIONS “™* (tson, Princip investigator: Dr Oteon- 8% fort Wil supervise the personnel actives of the CAFE project and take primary responsibil for assring the ann end "uparision othe sta. Pil work hte ene tam of investigator: e develop ad inplementeerutment and oe op of ptens inthe protocol. Pil paricipats in canterences and stperise the data management a te pesject. Vortech, Coswestigator: Dr Vuebetch- Efe ‘Wl assist in dhe training and supervision of the tal, Wi work with toe team a develop and implement ervtment and fotos-up cae of pater in the proses, Seta, Dotnvesgatr: ‘Wi assis in tne traning and supervision ofthe tall. Wil work withthe nic tem develop andmplament eezutiment ane follow-up care of paint in he potoc Ye¥80%, 12-00% and ¥F4-70% fot "Work clesing wi Pio do ecruient, patent iterviewing oversce data en, and msntan good conmuucation with Astrazeneca Pharmaceutias, YO BE NAMED, Clericaate Ent: (st etion) Resuired data erry, coping, and oer support services SUPPLY JUSTIFICATIONS =" i Paton sereeningsuppis- Ofc supple necessary todo patent sererings. Lab supplies -Lab supplies for required test. ice supplies Otfce supplies for orespondence with subjects and company. PATIENT CARE JUSTIFICATIONS Hospitaized Patent are (400 x 2ays) "the inition ae fr tise is 0 AstraZeneca suthorzes “bed” costs orn pate up to 400 peda for upto 3 das ove the tt sty, ">" OTHER EXPENSES JUSTIFICATIONS "=" ‘Advertsing - Advising or reeultent of jects ‘Required subject ab tests Subjects equred ECGs and other laboratory specimen preparation and satis ‘Subject Paynes - Each subjects reimbced $10 pr visit. t aa Pont Number panes conecivay athe ot sath appton Oo a UM SPA 9236E TERNAL PEER RE\ Principal Investigator Stephen Oso M.D Iw (Typed Nome) jnatire Department: Psychiatry Co-nvestigator(s): Carlos Schulz, M., John Vuchetich, M.D. Industrial Sponsor: AstraZeneca Project Title: Efficacy and Tolerability of Olanzapine, Quetlapine and Risperidone in the Treatment of First Episode Psychosis: A Randomized Double Blind 52:Week Comparison ‘Summary of Peer Review: 1. Faculty Effort Certiication 2) Percent of efor dead to hts projct S_s 2) Percent ot salary (Smale toa sear or NI cop) _S_ ©) Doos a= 07 mE __No @) This percent effort is appropriate fr this projct. Egy __no 2. There is sufficient space and time to conduct this research, eG __o 3. This research Is consistent with Division and Department goals mae No 4. Confic ot Interest (GO}) regarding P's Business and Financial issues: (abe AREPA Defiitions in EGMS) 2) PRFV2223 rm’ completed and signed by Pl and department heads. BREE Ne ) AREPA Fann 194 has been approved within the last 12 months. wy _no 6) This project involves 2 “Polen COL thats of $10,000 or ore, 5% crore involves famiy members exectliveposlion cova. ete, URGES © SURAIRED 10¥es, submit the folowing. new AREPA Form 15 4 narrative aisciosure explenation and a conflict mariagement pla. 6) This project involves “GIFT valued al $1,000,0¢ mare = sme | ¥s, tho cisciosure explenaiion is ettached, ‘This project has been rovlewed under the Department of Psychiatry Paar Review process and is recommended as being appropriate for submission, The submitting facully member has provided assurance moe fifo i “Ware and Signaie of Peor Review Panel Designs or sion Diedlor Tirta 0 BI 0 bp — ahg for ‘lalperson or iee-Chapeteon Approral | THIS PEER REVIEW FORM CAN BE USED FOR ANY AGENCY GRANT APPLICATION Grante2000HoWTos doe ‘Questions? call 6263545 12/8100 1 _ UM SPA 0228 SExhibit A. STUDY BUDGET, PAYMENT SCHEDULE AND PROCEDURES. PROTOCOL NO: — SO77IL/OLI4 INSTITUTION: University of Minnesota PRINCIPAL INVESTIGATOR: _ Stephen Olson, M.D. PATIENT ENROLLMENT CLOSING DATE: August 2003 DATA COMPLETION DATE: September 2004 MINIMUM ENROLLMENT: 20 Subjects MAXIMUM ENROLLMENT: 30 Subjects BREAKDOWN OF PAYMENTS 1 INITIAL PAYMENT 516,362 Upon receipt and approval of all regulatory documents and this signed Clinical Study Agreement, AstraZeneca shall forward a payment of $16,362 (0 the representative noted below. This Initial Payment is a refundable, advance Payinent for the first patient enrolled and will be deducted fram future Per Subject Payments. If Institution docs wot envoll at feast I Subject into the Study within 8 weeks of the date of its receipt of the Study Drug, this Agreement ‘may be immediately terminated by AstraZeneca, and Institution shall refund to AstraZeneca the $16,362 Initial Payment UM SPA 0446 ofAstrazeneco 2 CLINICAL STUDY AGREEMENT ‘This CLINICAL STUDY AGREEMENT (“Agreement”), dated as of the last date ofthe signatures below, is by and among AsuaZeneca Pharmaceuticals LP. a Delaware limited perinership with offices at 1800 Concord Pike, Wilmington, DE 19850-5438 (“astaZeneca”), and The Regents of the University of Minnesota, 3 Minnesota corporation "Tnstiution”), with a facility at 200 Oak Street, SE, Minneapolis, MIN $5435 with Stephen ‘Olson, M.D. 25 ("Principal Investigator”) 7 WHEREAS. AswaZeneca wishes to conduct a mult-cener clinical study of Seroquel™ ("Study Deus") and WHEREAS, Institution has appropriate facilies and personnel, and Principal Investigator has the ‘qualification, waning, knowledge and experience necessary 1 conduct such acliicsl study. NOW, THEREFORE, i consideration of te foregoing premises and for valuable consideration, the receipt 1nd suficieney of which are hereby acknowledged, she parties, intending to be legally bound, agree as follows 1, Saupe of Work. (2) Institation and Principal Investigator shall conduct the clinical study entitled “Erficacy and Tolerabibty ‘of Olatzapine, Quetiapine and Risperidone in the Treatment of Fist Episode Psychosis: A Randomized Double Blind 52 Week Comparison” (ihe “Stedy”) in aceordance with this Agreement, Protocol Number SO77HL/OL44 ‘Incorporated by reference herein and as may be amended (the "Protocol", goed clinical and medical practice. and ll applicable laws rule. egulations and guidelines relating to the conduct of elinca investigations including, without limitation, 21 CFR. Pars 50, $4, 56, and 312 (tbe “Applicable Laws"). Far purpose ofthis Agreement the term “Insttuinn’ shall include all alter employees, executive, cfficers, director, faculty, staff, and other authorized agents of Insiution (b) AstreZeneca may retain contract research ions (*CRO") to asi AsiaZenecs in managing, ‘monitoring and otherwise assisting with the Study. Tastttion and Principal Investigator acknowledge AstazZeneca’s ‘ight to assign or vansfer, in whole or in part, without the consent ofthe lnstiuton or Principal Investigetor, any of lis right or obligations under this Agreement to any such CRO. Institution shal permit such CRO to perforni any or all of AstraZeneca's obligations wider thie Agreement 2. Principal Investigator. Principal Investigator represens that he or she has read and-vnderstands the Investigators Brochure forthe Protocol. Principal lovestigator shall supervise the sork ofall pesons who assist in performing the Study. Prior 10 the commencement of the Study, Iestiution thal deliver to AstraZeneca true, ‘complete and correct copies of Principal Investgate's investigator sateient on Form 1572 and curriculum vitae, tach of which shal be signed by Principal fnvesigatorDusing the Swsdy, Instction shall imnediately notify ‘AstraZeneca in writing a sch time xsi becomes aware that Principal Investigator plans to leave Institution or shal bbe unable to complete the Study. IF Institution and AswaZeneea are unable to agree on an acceptable substitute investigator within fiften (15) days following such notice, this Agreement may te terminated by AstaZenece pursuant to Section 23 hereof, : 3. Representations, Warranies_and Covenents. Instntion represents, 0. AstraZeneca, and Principal Investigstor represents, co AstraZeneca (fo the extent that such representations, relate lo Principal Investigator), as follows (2) Principal Investigator is dnd at all rimes during the course ofthe Study shall be, qualified by raining ‘and experience with appropriate expertise vo conduct the Seu | (©) Insttuion and Principal investigator have, and at all times during the course of the Stody shall have, the appropriate licenses, approvals and certifications necessary to safely, adequately and lawfully perform the Study se eine 200 AstraZeneca Pharmaceuticals LP Mow ssraepacnc som {200 orcad Phe PO Bor 5637 Wanalon CE 198 ex? UM SPA 0076 5(©) Neither Institution, Principal Investigator, nor any other person who asi in performing the Study is subject to any conflicting obiiguions of anything that right interfere with the performance of the Study or that might impair the acceptance ofthe resulting data by the US. Food and Drug Administration FDA"). (2) Mosttuion, will not use the services of any person, including Principal Investigator, who is deberred oF proposed for deburment under dhe Federal Food, Drug and Cosmetis Actin compaction wil this study. Institution ‘will promprly only AstraZeneca it any person who atits in performing the Sady beeomes so debaced 4. asiltes. tnsittion and Principal Investigator shall contuct the Stody atthe facility frst identified above, or such ther Fucilies as AstraZeneca and Institution andor Principal Investigator may agree in a separate ‘writen agreement, and as shall be listed on FDA Form 1572 (the “Faciliy") Iyaituion shall make available all personnel, fclties and resources necessary 6 efficiently and expeditiously accomplish it esponsibilities under this Agreement ‘5 Subest Enrollimens and Yaformed Consent (2) Principal investigator shall enroll subjects into the Study in accordance with Exhibit A (each, 2 Subject"), Principal Investigator shall use bess effors to complete ll enrollment by the Patient Enrollment Closing ate set forth in Exhibit A. The Siody period may be extended or shortened andfor the aumber of Subjests Institution may caval in the Study may be changed, at AstraZeneca’ sole diceretion (b) Principal investigator shall obtain the informed consent of each ofthe Subject prine ta any screening ot udy and in accordance with Applicable Laws, An informed consent form that has been reviewed and approved by Astra7eneca shall be completed foreach Subject, 6 Compensation For the services to be rendered hereunder, AstraZeneca shall pay Institution jn sccordance with the badge, payment schedule, and procedures set forh in Exhibit A. Any srounis paid by ‘AsieaZeneea 19 Institution for reimbursable expenses not used by Tuition to pay the applicable expenses shall be Prompely retured to AstaZeneca Instiution acknowledges and agrees thatthe paymens: made by AsisZaneca represent AstrwZonevs’s total obligations under this Agreement and flly coer the costs of conducting the Study, except with expect 1 thove ekpunses reimbursable under Sections 19 and 234) heseof 7 Financial Disclosure Information At AsteaZeneca’s request, Principal Investigator shall prompaly provide 1 AstriZenaca Financial diselosuresiatemenis in compliance with 21 CFR Part 54, in de form required by ‘AstraZeneca and execated by Principal Investigntor and any subinvestigators and such other Financial information 35 ‘AsiraZenece may Teatonably fequest. During the term of the Study and foro period of oue (1) year thereafter. Principal Investigator and any subinvestgators shall promplly notify AstraZeneca of any changes in or additions 10 ‘such financial information. 8, Ownciship snl Conttol of Study Drug. Ail Study Drug supplied to Lostiuion shall reraip the exclusive property of Ast87eneca unl administered or dispensed to Subjects during the couse ofthe Sut. The Study Drug Shall only be used a¢ described in the Protocol in compliance with Applicable Laws. Upon termination or completion of the Study, Instntin shell at AstraZenecas direction, either rum to AstraZeneca or dispose of any ‘quantities of unused Siady Drug in accordance with AstaZeneca's structions. tnctitution shall maintain complete sd accurate records relating (othe dispesition ofthe Sody Drug supplied to Institution at Asta7enece's expense, 9. Diselsimer. Without limiting AsiaZeneca's obligtions under Sections 18 and 19 hereof, ASTRAZENECA DOES HEREBY DISCLAIM ANY AND ALL REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESSED OR IMPLIED, WITH RESPECT TO THE STUDY DRUG, INCLUDING, WITHOUT LIMITATION, ANY. REPRESENTATION OR WARRANTY OF QUALITY. PERFORMANCE, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE, O8 THAT ‘THE USE OF THE STUDY DRUG FOR PURPOSES OTHER THAN SPECIFLED IN THIS AGREEMENT WILL, NOT INFRINGE TITE RIGHTS, PATENT OR OTHERWISE, OF ANY THIRD PARTY. UM SPA 0077 &10 Bs sand Regula anes, (2) fastitution shall prepare, maintain, and rain complete, current, acwate, erganied and legible Sey Docurpetition in a manner acceptable for the collection of data for submission ta or teview by, he FDA and olher ‘epulalory of governmental authorities, and in fll compliance with the Study and all Applicable Laws. For porposcs of his Agreement (“Study Documentation” includes all records, study personnel's writ accounts and reports and ata relating tothe Stay, wheser in ein, electronic, video or olber tangibe frm (Gi) “Source Documents" incuses all recorded original observations snd notations of clinical activites and all reports and records necessary for the evalalion and reconstruction ofthe Sty, regardless of form (®) _Insiution shall provide 10 AstraZeneca documentation verifying review and approval by al Ingituionat Review Board approved by Lastiution ("IRB"), of tke Protocol, the Investigators Brochure, and the information to be provided to potential subjects of the Study to secure their informed consent; original eae report forms for each Sobject panicipating in he Study; and such ober repos when and st required by the Siady or Applicable Laws. fnsitution shall provide the fins data and report required by the Study no Inter than the Data ‘Completion Date set forth in Exhibit A or such ater date as AstaZenece may require (©) Av the request and expense of AstraZencea, IneGtuion and Frincipel Investigator shall (i) assist AscxZeneca i the preparation and submission of investigational new drug applications, new drug applications, nd any other premarket application relating to the Study and marketing wpplicaions relating to the Siody Dna, and (i nen meetings withthe FDA and other egulatory or governmental suthorties regarding such applieationé and the ‘sociated approvals 11. Audit and Review. AstraZeneca or its suihorizad repreentatves shall have the right, upon advance: ‘notice, a its expénse, and during regular business hours and a ines roualy aged upon, to: (a) audi alt Facies used in performance of the Study; (b) monitor the conduct of the Study, (€) review, copy and audit all Sudy Docurentation; any other books, records, data and Work Product (as detined in Section Lae) below) relating 0 the Sudy or the IRB: and all required licenses, certificates ard accreditation; (2) review and auiit all Sowoe Documents; and (2) interview Principal Investigator and other persons who asisted in performing the Study 52, Changes to the Protacol. No change in the Protocal shall be made by Institution or Principal Ivestigetor, subject to any Applicable Lows relating to the safety of research subjects hat requie a deviation from the Protocol, in which case Instittion shall immediatly notify AstrwZeneca and the IRB of the facts necessitating, such devistion as soon as the facts are knowin to Trsiution, AstraZeneca may at any time make changes in he Protacol upon Five (5) days" advance written notice to Tnsiaion; provided, however, tha, unless the changes are requied.by Applicable Laws, do nat materially invease the cost f perfnrmance of the Study by Institution oF are ‘otherwise agreed to by Institution, fastitution may terminate this Agreement pursuant Section 23 13, , Regulatory Inspections. If any governmental or regulatory authority (3) contacts Inaiation ot Principal Investigator with respect 10 the Study, (b) conducts, or gives noice a its inten co conduct, an inspection at any Facility, o (cakes, or gives notice of is intent to take, any other regulatory action with respect co any activity of Tnatuion, the IRB, or Principal Investigator which could eeasonably be expected 19 impact any data or clinical satvily under the Stody, Institution shall promptly notify AsuaZences of such contact or notice urless the _government or regulatory authority states a preference tothe contrary. AsiZevoca shall have the ight w be present 4 und to participate in any such inspection or regulatory action with expect ta the Srody. Institution shall pcovide AsraZeneea with copies of ll pertinent information and décomentation issued by any governmensal or regulatory Authority and any propoted response. AstraZeneca shall have the right to review any responses which may be requzed and which perain to the Stady. No such response shall contain any Ialse or miscading information ith respect ta the Study, the Study Drug or AsteZeneca 14. Ounership of Bauipment, Intellectual Property and Work Produc. (a) AIL materials, documents, data, software and information supplied 10 Insinution by AsttaZooeca or prepared, eveloped or generated by of on behalf of Institution, including bat nat limited to Source Documents and UM SPA 0078 7 7Study Docamenttion (exeloding records which are solely patients? medica records) in connect the performance of its obligaions under this Agreement (the “Propesty") shall be and remain the propeity of ‘AsteZeneca provided the Insnuion niay retain copy ofall material, documents, data and informavion prepared, developed or geverated wer this Agreement in order (0 poblish in accordance with this Agreement. Any such Property shall be delivered tb AstraZeneca hy Institution immestntely upon demand and wt AstaZeneca’s expense For purposes of this Section 14, "AstaZeneza” shall include any designee of AstraZeneca, including any direct oF inditet affiliate of AstraZeneca pl. with de Study oF () Astrazeneca shall uw al righ, tie and interést in and 19 any equipment supplied by, or purchase at he expense of, AstraZeneca (the “Equipment”, unless ulhersise specifically acknowledged hy AsirsZeneca in ‘writing. Insiucion shall make any VIC orotic filings aecesary to secure and evidence AstraZeneca's ovmership ‘of the Equipinent as und when requested by Astra7eneca. Tastution shall (i) use the Equipment only Cor the purposes described in the Sty or such other porposes as AstraZeneca may approve in ving, (i) fester exces 1 Snd use af the Equipment to Principal Investigator snd other personnel for whom such access and se is required 10 tenet the Study, and (i) deliver the Pquipnicat ro AsuaZenece or its Gesipner on the earlier ofthe eompletion of the Stly, the lermization or expiration af this Agreement, or as otherwise requested by AstaZenece at IauraZeneca'seppense. AstraZeneca will be responsible forthe mainienance of this equipment (e) Bach party shall retain oll right, tile and interest (collectively, "Rigits”) in any patent, prent application, sre secret know-how and ciher intelleesal propery that was owned hy such party prior tothe dae of this Agreement nd no license grantor assignment, express or implied, by estoppel or othérui, is intended by, oF stall be inferred from, this Agreement (a) ‘The panties recognize that inventions and discoveries, know-how, trade-secrets and other intellectual ‘propesty ineling improvements, whether patentable ar not, ray be conceived, reduced to practice or otherwise Fade by lasttuion, Principal Investigator or en other person who assist in performing the Stdy (whether solely ur rim with others} (each, an “Inventor”) in connection withthe Study oc the pexformnce of ebligstons under this ‘Agreement (“inventions”), AstraZeneca shall own all Rights to each Invention, and Insitwion shall eause each Thventor promgily to lake any ations necessary to asign and wansfer such Rights te AstraZeneca, inclading but not Vite to the fllowing 4) disclose ta AstetZeneca in writing the conception, reduction to practice or making of such ovention; and (ii) without additional consideration, asign and transfer (o AstraZeneca al Rights 1 patents, patent ‘applictions, and Rights 1 file for patent protection for sech Invention throughout the world, and provide such flocamentation and testioony as AstraZeneca inay reaseashly cequite in conection withthe application therefor and prosecution thereo. (6) tostvtion shall fully disclose 4o AstnZenece all work, teponts, writings, ideas. designs, methods, computer sottwire and dala recorded in any form that ate crested, developed, writen, conceived or faventions oF tiscoveries made by Institution, Principal Investigator or aay other person (whether solely or jointly with others) as 8 result of or in enonection wth the Study or the performance oftheir obligations under this Agreement (collectively. "Work Product’). Instttion and Principal Investigator each hereby irevocably ussigns, ot Lostittion shall enuse Principal Investigator and each other person to irevocaby asign to AstnZeneca al of dei respective rights, tiles land interests worldwide in and to such Work Product. Such assigamens shall include the righ to all eauses of seton for copyright infiagement of any such Work Product, including, without limitation, the right to institute, proces tefend and sete any suitor other legal or administrative proceeding, o enjoin infringement or misappropriation of och Work Product, gether with the sole Fight to any resulting recovery uf damages, royalties, profs, legal fees and cost. {t) Institution andor ineipaltnvestigator shill, and shall cause any Inventor or any other person to, where applicable and consistent with the requirements ofthis Agreement, () execute all documents and perform lf a6ts eemad necessary by Asis7eneea to evidence AstaZeneca's ownership of any Investion and Work Product {including, without limitation, the making of any biological Jeposts), and (i) assist AstraZeneca in preparing, Drosecung, oblsinng, registering, maintsining. defending and cbfrcin, at AxraZeneea's cole expense (for actual Costs incurred), discon and exclusive conto all United States patents (including, without Fimitiion, sey ‘ and UM SPA 0079 ¥Aivisons, continuations continustions-in-par, eisaus, renewals, exiesions or the lke of any such patent) and any foreign patents or equivalents thereof (ineluding, withoUt limitation, eericates of invention), copyrights, trade secre rights and other proprietary rights im and tg the Inventions and sueh Work Product in any an all counties as ‘may be determined by AstraZeneca {g)_Instittion and Principal Investigator each hereby inevocably appoines AstraZeneca, and fnsixtion shall exuse each other Inventor of any other person, where applicable, itrevoeably to appoint AstraZeneca, 2 it, his ‘or her, as applicable attorney-in-fact fr the purpase of executing such documents in their respective names as my ‘be necessary or desirable to carryout the purposes of subparagraphs () through (F) heseof. (2) The putes hereto agree that all activities under this Agreement (“Agreerent Activities") shal fll itside the planed and commited sctivities of any government funded project undertaken by Intition andor, Principal Investigator ("Government-fondeit Activities") and sall not diminish or distract from the performance of such Governmentfunded Activities within the meaning of 37 CFR §401.1(aX1), and therefore, that any Invention ‘made hereunder shall nt be éubject tothe conditions of 37 CFR Chapter IV, parts 401 and 404, Jn the event that Agreement Activities sall be found to be Goverament-fonded Activities, Institution and/or any other Inventor shal take all actions necessary to retain tile to any Invention mide under this Agreement, incloding those required by 37 CFR §§401.14(€(D), (2), und (). fh the event that any Inventions or Work Product conceived or reduced to practice, made or developed by any Inventor hereunder are controled by federal law in accordance with 37 CFR §§ 501.1 = SOL11, the partes hereto agree that any license granted 10 any Inventor to such Invention controlled by Federal la, arising fFom Agieemnent Activites shall be worldwide and exclusive, subject to te right of the United State to elan an revocable, royalty-free eight (o use the inventions roughout the U.S. Goverument 15. Confidential Information (a) For purposes of this Agreement, “Confidential [nfrmaGon’” meané any information of AsuiZenees, whether of a technical, business of ober nature, including, but aot Timited 16, inforsation that relates 10 ‘AsoaZeneca's trade secrets, reducis, promotional material, developments, proprietary rights or business fais. together with any laventions, anything marked 2s Confidemial by AstraZeneca, Work Product and all other information cllected, prepared, developed or generated by Insittion, Piscipal {nvestigator and aay other person pursuant lo this Agreement except az requzed by law and academic policy, including tis Agreement. Confidential Tnformation does not include any information that: (0 nstiwtion andlor Principal Investigator ean prove was known (0 it prior to the date of this ‘Agreément and was not subject 1 any confizentality restrictions, i) Institution andor Peincipal Investigator can prove was lawfully obtained from a third party without any obligation of eonfidentiatiny: (i) Ie oF becomes part ofthe public domain through no act oe violation of any obligation of Istituto noe Principal Investigator o¢ Gv) Required tobe disclosed by law, regulation or court order, (0) For a period of seven (7) yeats (rom receipt of Confidential Information, Insckution and/or Principal Investigntor shall not, without AstraZeneca's prior writen conient or as may be permited by thie Agreerment disclose to any third, party any Confident Informatica, and shall use such Confidemial Information solely for purposes of performing its obligations under this Agreement Insiuion shall restrict the dissemination of Confidenvial Information 19 erly those persons within ils organization who have a noed to knov, ané shall ensure that tey ate aware of the obligation of confidentiality requiet by this Aprecment and are similarly bound. Instiution andlor Principal Investigator shall use at least the same care and dieretion in maintaining the confidentiality ofthe Confidential Information af it uses with ils most sensitive confidential inforation, institution andor Principal Investigator shall notify AswaZeneca promptly upon Instittion andlor Principal {nvestigaters iscovery of any loss or compromise ofthe Confidential Iforation. Upon the termination or expiration of this ‘Agreement or upon AsiraZeneca's earlier request, Institution andlor Principal [nvesigator all promptly return to ‘AstraZeneca all Confidential Information UM SPA 0080 4{} Notwithstanding subperagraph (b) above, if natitcion andor Principal Investigator arc legally required to disclose Confidential Information andlor results of the Siudy, Jositudon andor Principal Investigator shall [promptly notify AstraZeneea in siting no less than (ive (5) business days prior @ making the required disclosure Instituron andlor Prinipa) Investigator shall craf such disclosure as reasonably requested by AstraZeneca so tha such diselosure shai! easain only such Confidential Information as is required by Applicable Laws. Nothing ‘conizined herein shall prohibit Instiotion andlor Principal [avestigaor from disclosing results of the Stody 10 the extent necssary to prevent or mitigate a serious health hazard, provided, however, that Inston andor Principal fnvestigatgr shall notify AstuZeneea prior to making such & diselosure, and immmedintely fer it has made such a aisclosue (2) With respect tothe Subjects medical records, the parties agree fo hold in confidence the identity ofthe Subjects in accordance with Applicable Laws. 16, Rights te Publication. («) Lostiuton and Principal Investigator acknowledge and agree thatthe Study is being conducted as part of a multi-center elnical wal, hat data foun all sch centers will be pooled and analyzed, and tha disclosure of data Troma single site may be misleading, The publications and presenistions of data coming from the Study willbe ‘governed by the publications and presentations plicy dxermined by the steering commie of the Study which wil ‘he comprised of individuals from the coordinating center (University of Nonh Carolina at Chape Hil) site invesignors and represcoratives of AstraZeneca. Subject to this Section 16, Institution and Principal Investigator ‘may submit for pablcation any manuscript, abstract or other document, nd present a any meeting, any data ‘enerted o rising from the performance ofthis Agreement after AstraZeneca or is designee publishes an stile 00 the Study or aller twenty-four (24) months have elapsed since the completion of the Stay at all sites, whichever ‘osoui ist provided, however, that nether Institution not Principal Investigator may take such action with respect te any publication or preseninion, or poction tereof, tat AstraZeneca derermines() isin violation of Section 15 Thereof (i) nox consistent with aeademic standards, i) e false or misleading, oF (v) i for commercial purposes, () InsGition andlor Principal fovestigator shall submit a copy of any proposed manuscript, abstract, presentation 9 oler docuinent 1 AsiviZeneca for review and comment at least saty (60) day prior wits Tubrission for publication or presentation No publication or preseatation with respect ro the Sindy shal be made Unless all AstraZeneca Confidential information has been removed. Institution andor Prneipa Investigator shal onsiderin ood faith any AsitzZeneca comments. Uf requested in wring by AstaZenece, Istituto andlor Principal Investigator shall withhold material from submission fr publication or presentation for an addtional ninety (90) days to llow for the filing ofa patent application or the waking of other measures to establish and preserve AstaZenecs's propretcycights, To the extent that any provision ofthis Seetion 16 may be inconsistent in ny respect with any stalements abot publication policy set Forth in the Protocol, the provisions ofthis Seetion 16 shall conc. () tnsinution snd Principal lavestigator gree tha, if either publisher te results ofthe Siudy, AstZaneca is bereby granted an ievorable, royalty-free ficense to make and cstribute copies of such pobicaton under any copyright privileges that lnsttation or Prigipal Investigator may have. AstraZevecs alo shall have the right to publish insopendenty the esults ofthe Study i the ageregate 17, UspofName; Advertising. (a) Subject to Applicable Laws, neither Insttuson, Principal Investigator, nor AstraZeneca shall mention cor vihenwise use Whe name, taidemark, trade name or Jogo of dhe other in any publication. press release, of promotional material with tespect t0 the Stwdy without the prior writen epproval of the other party. provid, however, thot AstraZeneca shall have the right to identify lnstiuson asthe site at which the Study was conducted nd io identity thas individuals responsible Tor conducting the Study (Ca ostttion and tnvestigator shall not issue to the public any information oF statement through the press oF any other media, including but not limited to advertisements for de enrollment of Study subjecs without the prior “writen permission of AstrsZaneca and te review and approval of the RB. UM SPA 008118. Indermification by AstraZeneca, (a) Pxcepr asset fonh below, ActaZeneca agrees to dafen, indemnify and hold haemless Institution, 56 officers, employees, gents, and Principal Investigator (collectively the “Insttional Indemnified Parties") from and against any and all labiity. claims, losses, damages and expenseé (collectively, “Tases") for bodily injury ot dea to Subjects dicey e be ‘of the Surly Drug if Instation and Principal Investigntar (i) have complied sith the provisions of this Agreement, the Protocol ané all written instructions of AstraZenec ‘voncemning sdiinistation or use ofthe Study Drog, (i have usd reasonable medical jugment inthe adminstati Df the Sigdy Drug, and (il) otherwise acted in conformity with generlly acceptee. standards of the mestcal community in which they practice ond without negligence or willl misconduct, AstraZeneca shall have the exclusive right to rain counsel of its choosing 10 cepresont the [national Indemnified Parties snd shall retain exclusive contol of the litigation, including, without limitation, th right to make any compromise or serlement, provided that AstaZeneca shall nar make any settlement admitting fault onthe pat of Institution without its writen Cease, such eoneent na to be wnreaconably withheld () Astra7enece shall have mo obligation to defend, indermity or hold Karmless any Instiutiénal Indermified Party under this Agreament with respéct to a Loss unless Instiution or Principal Investigator fas provided AstriZeneca wich writen notice of such Loss within fifteen (15) business days of reecipt of any ela oF fut raring to & Loss. The Institutional Indemnified Panties shall allow AstraZeneca to assume the defense of any such Les, inclsing the right to select defense counsel snd the righ to scile any Loss as sat forth abave, nd shal cooperate Rly wih AstraZeneca and its agents and representatives in he investigation and defense of such Lass (e) Termination or expiraiion of this Agrotinent and the Study shall not affect AstraZeneca’ obligations to ‘he Instiutionel fndemified Parties with respect to any claim or laweuit based upon administranon of the Siidy Prag wader the eiwumsanees set forth above pri to Institution's and Principal ovestigator's receipt of notice of termination. 19. Subject Injury. AstraZeneca shall rcnburse Easttution for the direct, reasonable, and necessary medical expense for the lreatment of any bodily injury that isa dicet result of the administration ofthe Study Drog iF Gi) insvution and Principal Investigator have complied with his Agreeent, tbe Protocl, any write instructions ‘of AstraZeneca conceming the Study, and all Applicable Laws, i) the Study Drug was taken as presribed, (i) all the requirements of informed coosent have been complied within acordance with § S(h) hereof, (iv) the injury was nol deliberately caused or a result ofthe negligence or willful misconduct of Inttlion or Principal Investigator, (¥) Princip Investigator was immediately navitied of the injury and (vf) the medical advice of Principal Investigator ‘was followed, Compensaiun for lost wages or any other damages, expenses, or losses, or for maical expenses Which have been covered by a subjedt's meical or other insurance will not be reimbursed by AstrsZencca 20, Indemnification hy Institution. (2) Inston shall defend, indemnity and hold harmless AssaZendea and is ofiars, decors, pare, «employees and agent (AstraZeneca Indemnified Paces") from and against any and all Lesses eaused hy 9 breach of tk Agreement by an Ingitutona Inderatfed Paty, including, witout linitadon, the negligence or wilt miccondsct of Institution, Principal Investigator, or any olber person who assists in performing the Study. in Peforming Weir cbligasons under his Asszema.o cased by the tre of Istidon, Principal Invest gator, oF ‘ny oer person who assis in performing tbe Sty, wo comply with th provisions of thi Agrees he Praia, ay ‘kilen inocions of AstZeneca copceming De Study oF aay Auplable Laws, Notwihsanding Ue {ocegoing, Tasiution shall have oo obligation pursuant to this Ageement to defend, oderify ex hold harmless an ‘stZeneca Indermifed Pany fom any Locos o the exten caused by a brcach of thie Agjecinent by an AstaZeneca Indenfied Pan, ncading by auch party's negligence r will misconduct () tnsttation shall have ap obligation to defend, indemnify or hold aumlesswny AstezZenevs Indemnified Party under this Agreement with respect to a Loss unless the party staking indemnification i) provided Institution ‘with prompe, writen notice of sich Loes and (i) cooperetes Fully with Instittion an its agents and representatives in the investigation andl defense of such Toss UM SPA 0082 I21, Iosoranee (2) Institution shall maintain during tie term of this Agreement aid for a period of three (3). years thocvafer, th following insurance coverage: ( Commeccil General Liability for bodily injury and propeiy damage (including loss of use there 00) ‘with minimum lirits of $1,000,000 each occurrence and $2,000,000 general aggregate, ineluding Premises Liability, ProductsiComplcted Operations, and Contractual Liability coverage for the indemnity provided under this Agreement; {iy Workers’ Compensation as required by all Applicable Laws and Employer's Lishility coverage with afi of ma Tess Un $1,000,000; and (ii) Medieal Malpractice Professional Libiiy insurance as reuired by Minnesota State law (©) Bach of the above policies of insuiance shall be primary to any liability insurance carried by ‘AstiZensea which insorancefs) shall be excess and non-contributory for claims and Tosses arising out of the performance ofthis Agieement (e) Insttation shall, ot AstraZenece’s réquest, have its insurance carter or carriers, or with respect toa sell insurance prosram have an appropriate officer of Instiuion, furnish to AstraZeneca cerficates that all insurance required under this Agreement are in force, such cenfcue to indicate any deductible andfor self-insured tention Toetinution sal inumedincely provide AsitaZeneca with writen notice of any cancelation, non-renewal, expiration or material mdificason of any required insurance or self-insurance. \ 22. Team. This Agreement shall be effective ap of March 18, 2002 and shall continue oni the ealier of the date hm be final Study Documentation hab been provided to AstraZeneca following competion of the Study and the date thot this Agreement i terminated in accordance with Section 23, 23. Termination (a) “This Agreement may be terminated or suspended by AstraZeneca immediately upon wrtlen notice to Insivtion for eafey concerns or as otherwise required by Applicable Laws. AstraZeneca und fnativaiv reserve the right to terminate thie Agreement and Stdy 38 any tm in is sole dseredon ypon thet (30) days prior writen otce, However, AsinZeneca may tetminate this Agreement and Stody upon five (5) ays prior writen notice for ‘safety, regulatory or ethical reasons. (0) This Agieement may be trminazed or surpended by Lastitution iramediately ypon writen native 10 ‘AavaZeneea (for safety concems or a8 otherwise required by Applicable Laws, or (i) if Asta7aneco makes ‘changes tothe Study that are not required by Applicable Laws and not agteed to by Yasitutnn and such changes imateiay increase the cost of performance of the Stady by Insituton. This Agreement may be terminated by Tastttion, in its sole discretion, on thity (30) days prior writen notice to AstraZenee, {€) Upon notice of terination, Fstituion shall immedinely cease enrollment of Subjects into the Study and, al she election of AstraZeneca shall (i terminate the Study with respect to the enrolled Subjects in an orderly tnd prompt manger and pursuant to cGnsultation with AstaZeneca's clinical moniter, including, without limitation, any fequted follow-up teatmeot with previously enrolled Subjects (d) Except in she Gate of termination asa resultof an uncured breach of this Agreement by Instittion, ‘AstaZeneca shal (i) reimburse Institution for its reasonable direct costs incurred in connection with transfor of Subjects pursuant lo Section 73(c) above, and (i) with respect o Subjects who have not completed the Sy at dhe ate of the termination of this Agreement, make payments to Institution in accordance with Exhitit & for work steatly performed in secordance with the Study. {e) Wilkin thy 0) days ater the termination ofthis Agreement, Institution shall dover to Astedeneca ‘final accounting of all Subjects participating in the Stody and the visits completed in accoréance with the Study ‘oring ds tor of this Agreement, and all reasonable direct costs ineured in epanecton with any wanser ofthe 4 UM SPA 0083 [2‘Study. Within fony-five (45) days of delivery or receipt of the final accounting, either stitution shall fund to ‘AsiaZeneca any excess amovnis paid by AstraZeneca or AsuxZeneca shall pay any additonal amounts awed 10 Inaitution, asthe cate may be. AstraZeneca or its designee shall have te right fora period of two (2) years afer the payment of any transfer costo audit Institation’s books and records ih espect to such accounting, ‘24, Independent Conteactor, In undertaking to perform its services hereunder, Insittion and Principal Tnvestigaor are doing 50 a5 independent coriractors, and not as employées or ages of AsraZeneca. No party stall represent itself as an agent of any other party. 25. Astionment, No party shall assign this Agreement or any of i right or obfigatons hereunder without the prior written consent ofthe other pais, except that AstaZeneca, without the consent ef any other party hereto, may ussign this Agreement (a) in connection with the taneer or sale of allot substantially all ofits assers oF ‘sinass or it merger or consolidation with another company, or (b) to any director iodivect affiliate of AstsZenecs ple 26, Severability. any provision ofthis Agreement shall b held tobe illegal, invalid or unenforceable in” ‘whole oc in pact for any reason, the remaining provisions shall continue in full force and effect, and the paris shall substie a legal, valid, and enforceable provision with terms seilar to such provision ax may be possible. and reasonahly acceptable to the patios 2. This section intetionally omitted, 28. Notices. Any requited notice or other commonicaton shall be in writing and shall be deemed given only if delivered personally or sent by 2 telecopy (with transmission confirmed) or by registered or certified real, return receipt requesed and postage prepaid, or by Federal Express ran equivalent ovemight delivery service, addressed Io the partis st Hta AsaZeneca, to: to Iastntion, to: Technical Address: Dept of Psychiatry Address: 1800 Concord Pike 12450 Riverside Avenue Wilmington, DE 19850-5438 Minneapolis, MIN 55455 acsimile: 32-886:2730 Facsimile: 612-627-4808, Aawtention: Sie K. Saini, Eg Auenton: De. Stephen Olson With a copy to: ‘Administrative: ‘Adress: {800 Concord Pike ‘Address: Ofice of Sponsored Projects Aémin Wilmington, DE. 19850-5438 University of Minnesota Facsimile: 302-886-1578 430 University Gateway Awtention; General Counse} 200 Oak Suet SE Minneapolis, MN 55455.2070 9. Sunival. The respective rights and obligations ofthe parts set forth in Sections 7-11, 13-21, 23, 28 and this Section 29 shall indefinitely survive the expiralion or termination of this Agreement to the extent necessary to preserve such sights and obligations 30, Entire Agicement. This Agreement, together withthe Exhibits hereto, consies the entire agreement among the parties berelo with respect uo the subject matter hereof and all prior agreements with espect thereto are ‘superseded hereby. No amendment or modifications hereof shall be binding wnlest in writing and duly executed by authorized representatives of each porly, No waiver of any term ot condition ofthis Agreement shall be effective ‘less set forth in writing by the panty svaving such term or condition. In the event of any inconsistency between this Agieerser and the Protneol, the term pf this Agreement shall preva. a 431, Coumemans. This Agrcement may be execuced in one or rior counterpart copies, each of which shall bbe doomed an original and all of which shall together be deerme to constitute one agreement UM SPA 0084 13IN WITNESS WHEREOF, the paris here Glnical Suady Agreement a8 of the date last writen below. ASTRAZENECA PHARMAGBUTICALS LP ov Vheza ‘= RECTOR, SOURCING Oa AS a Tile__Grants Manager Dawe_5/16/02 10 ach by a duly authorized representative, ha PRINCIPAL INVESTIGATOR: px: he Vliet — Name: Stephen Olson, MD Title: Principal tnvestigatoe a. UM SPA 0085 14Exhibit A STUDY BUDGET, PAYMENT SCHEDULE AND PROCEDURES: PROTOCOL NO: _SO77HL/0114 INSTITUTION: University of Minnesota PRINCIPAL INVESTIGATOR: Stephen Olson, M.D, PATIENT ENROLLMENT CLOSING DATE: August 2003, DATA COMPLETION DATE: September 2004 MINIMUM ENROLLMENT: 20 Subjects MAXIMUM ENROLLMENT: 30 Subjects BREAKDOWN OF PAYMENTS 1. INITIAL PAYMENT $16,362 Upon receipt and approval ofall regulatory documents and this signed Clinical Study Agreement, AstraZeneca shall Forward a payment of $16,362 to dhe reprecentative noted below. ‘This Initial Payment is « refundable, advance Payment for the first patent enrolled and will be deducted from future Per Sabject Payments, If Iasttuon does not enroll ot least | Subject into the Study within 8 weeks ofthe date of its receipe of the Study Drug, this Agreement may be immpediately terminaied by AsuZeneca, and Institution shall rend to AstraZeneca the $16,362 tritial Payment PER SUBJECT PAYMENT. 816,362 Por Subject Payments shall be made for evaloahle, ligible Subjects only. An eligible Subject is one who meets Oe inclusiowexclusion requtements of the Protoce, who was entlled by Ineitaion and from wham informed Consent thas heen obtained. An evaluable Subject ie one for whom all CRES have been complied in accordance withthe Protocol, and who has complied the approprat study procedures asset forth inthe Protocol, and undergone the ‘evaluations tensied by the Protogol for assessment ofeficacy and safety. The per subject cost inchdes subject felated costs a8 well a non-subject costs such as overhead expenses, ECO prepsration & review, laborlony specimen prepsiation & analysis, blood pressure monitoring, psychiatric ratings, completion of case repon forms, stinintralive cst, costs for subject travel, et, and equipment costs. er Subject Payment shall become de for och evaluable eligible Subject upon AstraZencca'ssulisfactory review ofall Study Documentation, including completed CRF and close-out audits. No payments will be made fr Subjects with uasatstactory CRF or ‘unresolved data deficiencies in the Study Documentation. A completed CRP i one that is signed by Principal Investigator when required and contains all complete verified information in accordunce with the procedures and schedoled assessments as stated inthe Protocol Ina to te Ber Sbjen Paymen, Aenea wl py "bed cos fer inv pants up oH per ény (oeapto3 dae [AcrraZeneca wil pay for reasonable IRB fees upon review and receipe of invoiet te Quins, Ing © Attn: Payments 10201 Wateridge Circle San Diego. Ca 92121 ‘Clinica raters at the Snstitudon are required to complete the inital saining/cetfcation in order to participate in the siudy. AstraZeneca will not pay Cor this intl waining. AstraZeneea will pay 5250 for each ofthe e- ‘Subject: Re CAFE-Amendment 2 approvalsirevised ICFs. Ce: Bee: Attached: J:\Olson's trials \CAFE\Consent Forms\Adolecent Assent\ADOLESCENT 03-25- 03.doc; J\Olson's trials \CAFE\Consent Forms\Adult Consentladult 2-25-03 dos, J:\Olson's ‘rials\CAFE\Consent Forms\Parental Consentipatental 03-25-03 doc. Hi Amy, Attached youll find the most recent ICFs, The IRB really got mixed up with approving the Protacol change and so it wasr't until actually just this last week that we rec'd final approval ‘They approved the consents before approving the protocol. | now need to go back and have everyone else sign nev consents so they ate offcially informed of the protocol change. be faxing the IRB approval letters asap. If you have questions, lat me know. Jeannie ‘At 12:28 PM 7/1103 -0500, you wrote: Hie Can you please fax a copy of your amendment 2 approvals and revised ICFs? ‘They need to have these in the central fil! Thanks- Amy fax: 513-731-2159 ss+e0004*4IM PORTANT-PLEASE READ’ This electronic message, including its attachments, is COMPANY CONFIDENTIAL and may contain PROPRIETARY or LEGALLY PRIVILEGED information. if you are ‘ot the intended recipient, you are hereby notified that any use, disclosure, Copying, or distribution of this message or any of the information included in itis unauthorized and strictly prohibited, If you have received this message in error, please immediately notiy the sender by reply e-mail and permanently delete this message and its attachments, along with any copies thereof If this electronic message contains a zipped attachment and you do not have a decompression tool, you may download unZIP (free of cost) from. ‘ato www.mi-net-work.com/us/uziunzip.him, Alternatively, you may request that the attachment be resentin an uncompressed format. | Thank you Printed for Jeannie Kenney 7 UM CAFE 0582Jennifer. frantz@quintites.com, 10:04 PM 6/4/03 -0400, RE: Request for funds Page 1 of S X-From__: jennifer. frantz@quintles.com Wed Jun 4 21:12:42 2003 X-Umn-Remote-Mta: [N] mhub-w5 tc umn edu #4LO+NM X-Umn-Remote-Mita. [N] mail2.quintiles.com #+NE (I) X-Umn-Report-As-Spam: http'//umn.eduimels? BNinciQkQgTAS7AchZbbhgk21d4KoFBY H3n9sHhRNw Subject. RE: Request for funds To: Jeannie Kenney From: jennifer | frantz@quintiles.com Date: Wed, 4 Jun 2003 22:04:21 -0400 XCMIMETrack: Serialize by Router on QNEWLNO1/QNEW/Quinliles(Release 5.0.5 [September 22, 2000) at 06/04/2003 10:04:54 PM, \temize by SMTP Server on QRTPLCOZ/ARTP/Quintiles(Release 5.0.11 [July 24, 2002) at 06/04/2003 10:12:22 PM, MIME-CD by Router on QRTPLCOZ/GRTP/Quintiles(Release 6.0.11 July 24, 2002) at 08/04/2003 10:12:22 PM, MIME-CD complete at 06/04/2003 10:12:22 PM, : Seralize by Router on QRTPLCO2/ARTP/Quinties(Release 6.0.11 [July 24, 2002) at 06/04/2003 10:12:36 PM Hi Jeannie, This is no problem, AZ has given the okay for this pt and the associated {transportation costs. ‘This isthe template | made up for another site, they were tracking mileage, you can edit it to describe car service. Please include the visit number and round-trip cost. (See attached file: mileage reimbursement template.xls) Thanks, Jen Jeannie Kenney on 06/04/2003 11:59:28 To: jennifer frantz@quintiles com cc: Subject’ RE: Request for funds Depending on the mileage it would be between $30 - $50. One of oak ather Studies is using this service. it was more cost efficient than cab fare and is more comfortable as the clients are picked up in prety nice vehicles. Kind of makes them feel important Jeannie At 11:44 AM 6/4/03 -0400, you wrote: UM CAFE 0594 Printed for Jeannie Kenney 6/5/03, 8UNIVERSITY OF MINNESOTA Ambulatory Research Ceter Deporiment of ryehitry iveide Professional Bulaling ieee 6-4chAvenae Sat 7 Sine 602 Mineopeb. nw $5454 April 25, 2003 Quintiles, Ine. Mary Ann OHerron 10201 Wateridge Circle San Diego, CA 92121 Dear Mary Ann, Please find enclosed a receipt for refteshments. Our CAFE team presented information about the study at a private psychiatric outpatient clinic in the area. Itwas nice to provide {histo them as a way to acknowledge the time and attention they gave us over theit lunch hour. Thank you for processing this request. The staff person who purchased the food for this function is Elizabeth Lemke. If you have further questions, please feel free to contact me at (612) 627-4363, Sincerely, D Olea 1276 Kenreey gan M. Kemney, LICSW 0 CAFE Study Coordinator Ene, UM CAFE 0610 ™ efMonica Pallett, 11:21 AM 4/15/04 -040...: [cafesc] CAFE PANSS Rater Certification Statu Page 1 of 3 X-From_: monica_pallett@med unc.edu Thu Apr 15 10:22:13 2004 X-Umn-Remote-Wita: [N] mhub-m6 to.umn.edu [160.94.23.36] #+LO+NM X-Umn-Remote-Mta: [N] zebulon med.unc edu [152.19.4.47] ##NR#UF+CU (A,-) X-Umn-Report-As-Spam: To: "Jeannie Kenney" Subject: RE: FW. [cafesc] CAFE PANSS Rater Certification Status Date: Thu, 15 Apr 2004 11:21:43 -0400 X-Mailer: Microsoft Outlook, Build 10.0.2627 Importance: Normal BokC8KzbR | did receive Christa’s Jose” score sheet. don't have one from Angie Guimaraes or John Vuchetich yet, though Relablity is assessed for each year by analyzing the three scores of that year logether What we do with incividval reliability tapes Is look at the scores ang any ane who is more than 20 points out willbe asked fo Fescore now (unless itis in keeping with an overall rend af scaring high ar low). “Jose” is the first of tves for year 3 relabilly, the 2" tape #26 is being sent out this week. Ifyou don't hear from me after scores are Submitted assure that no news Is good news, Thanks, a Monica Original Message: Jeannie Kenney [mallto:kenne097@uma.edu) ‘Sent: Wednesday, April 14, 2004 12:30 PM ‘To: Monica Pallett ‘Subject: RE: FW: [cafesc] CAFE PANSS Rater Certification Status Hi, I went back and saw that in September of last year Dr. Olson was reminded that he was only certified for CATIE PANSS,not CAFE and that he would need to view the vignettes online! Looks like he did not do that. I have reminded him of this. I'm glad I save all of my e-mails bie I don't have the best of memories. Sorry about the confusion from this end. Jeannie PS ‘Also, Christa Surerus-Iohnson sent in her Jose tape. Have you received Angie Guimares or John Vuchetich’s yet? Also, will we receive results as to if we pass recertification? JeannieAt 10:10 AM 4/13/04 -0400, you wrote ‘That isnot possible 2s only one of the three tapes, Josephine , was viewed atthe investigator s ‘meeting I ve checked the excel spreadsheet that was handed over to me when | {Gok over the CAFE ‘Assessment Unit and also checked the hard copy fles and have no record of any CAFE PANS tapes being rated by Dr Olson Unless you can produce his original score sheels, {will ned him fo score: the CAFE certification tapes They are on the CAFE website, or VHS tapes can be sent if needed “Thanks, Monica UM CAFE 0665 Printed for Jeannie Kenney anisioaManica Pallett, 11:21 AM 4/15/04 -040..: [cafese] CAFE PANSS Rater Certification Statu Page 2 of 3 Original Message—~ From: Jeannie Kenney (mailto:kenne097@umn.edu} Sent: Friday, April 09, 2004 11:34 AM To: Monica Pallett ‘Subject: Re: FW: [cafesc] CAFE PANS Rater Certification Status Dr. Olson was certified to rate PANSS at the Investigator's meeting Feannie At 10:11 AM 3/30/04 0500, you wrote: Hi Jeannie, Dr Olson has nat viewed the Jose tape and stil needs to do so for CATIE However, he has never become certified as @ PANS rater for CAFE and therefore should NOT be rating the PANS for CAFE Ifhe'is doing so, or plans to do so, he needs to go on the CAFE website and score thoce three lapes ASAP (fax one page score shat la me at 919 B48 7367), Thanks, ‘Monica Original Message—— Jody Robertson (mailto:lody_Robertson@med, Sent: Thursday, March 25, 2004 10:18 AM To: 'Monica Riedy Pallett” Subject: FW: [cafesc] CAFE PANSS Rater Certification Status Does he? Original Message-~ From: Jeannie Kenney [mailto:kenne0: Sent: Tuesday, March 16, 2004 5:05 PM To: Jody Robertson ‘Subject: Re: [cafesc] CAFE PANSS Rater Certification Status Hi Jody, I don't believe Dr Olson ever did Jose. He still needs to do the recert doesn't he? Jeannie UM CAFE 0667 Printed for Jeannie Kenney 4115104 ~ leMonica Pallet, 1:21 AM 4/15/04 -040..: eafese] CAFE PANSS Rater Certification Statu Page 3 of 3 At11L06 AM 3/10/04 -0500, you wrote: Hello everyone, Please see the attached list of PANSS raters, by site, who are not currently certified forthe PANSS. Also listed are the items that are outstanding, Please see that all raters complete the PANSS on-line certification as soon as possible. Fee! free to contact Ismail Abdelktalek {giipweed@emal une.edu) if you have any difficulties with the CAFE website nk you, Jody Robertson Department of Psychiatry University of North Carolina at Chapel Hill phone 919 843 3420 fax 919 843 7859 Pager. 919216 0898 ‘You are currently subscribed to cafese as: kenne097@ymn.edu ‘To unsubscribe send a blank email to leave-cafesc-1433002N@llistserv une.edu UM CAFE 0668. Printed for Jeannie Kenney 4nis/os oe 7UNG SCHOOL OF MEDICINE DEPARTMENT OF PSYCHIATRY MEMORANDUM TO: CAFE Investigators and Staff FROM: ——_Jeffiey Lieberman DATE: December 15%, 2003 RE: CAFE Enrollment Kickoff Dear Colleagues, Wehave now worked iogether on the CAFE project for slmost two yéars. Our comamon goal sto complete {he study successfully and provide data that will answer erteal questions about the use of atypical Gauipsychotic drugs in patients in their first psychoti episode. I thank you for your superb efforts in making this tral possible and successful to date. Although recruitment has recently gone quite well, we stil must consider the risk for not meeting our target of 400 subjects, As of Sunday, November 30, 2003, we have enrolled 328 subjects out of our target 400, There are only 13 weeks left to enroll subjects and there ie ho Possibility of further extending the enrollment period. We have been averaging 20 new subjects a month for the past 6 months now but we need to enroll about 25 per month forthe remainder ofthe tial. Treach site fan enroll | patient per month in the xemaining 3 months then we will meet our goal. | encourage you to rake every effort to enter patients into CAFE inthis final stage of enrollment. With a litle extra effort, we will succeed. ‘Best Wishes to All for a Happy Holiday and Healthy New Year, Jeffiey Lieberman The Universiy of Nrdh Coraline wt Chapel Hil, Conpus Rex 87160, Chapel, Noth Caroling 27599-7160 Telephone: (918) 966-590; FAX: (19) 66-8994, EstAILe Hichermmmipine cee UM CAFE 0677 gIn Page 20f4 Thanks for ‘sending that info on to me&l look forward to the details. Regarding the proposed thank you gift Tine Olexy at AZ has agreed to reimburse your site for the full $400 cost of the booth. As we discussed, Eiease create and submit an invoice for tis emiece y Maria Karvois, and ‘She will have it Processed for payment. As for the CAFE brochures, M&Ns, Were able to track those down, evenifit was a wid goose chase. J Please let me know if you have any questions Thanks! Jody Original Message From: Jeannie Kenney mailto:kenne097@umn edu Sent: Monday, September 15, 2003 11.67 ait Ge: Jody Robertson; jennifer rantz@quintiey com Ce: Elizabeth Lemke Subject: RE: Jody's address Jody and Jen, hanks for the address. Im glad | checked. It's not Close to the one | thought it might be, Jody, tm finally Sending you the program for the Mental Health Conference we're attending next week, Freabeth and {made an executive decision about what We would lke as a peank You forthe recruitment presentation. To ores the cost of our Booth and to buy chocolates to attract folks to ve wee tee toask fora $200 6. ait Not knowing exactly what is reasonable we ors throwing out So £200.00. Our booth costs about $400 and ne Spent about $80.00 on candy ear tg last year. Any idea when we might receive the brochures and other CAFE items (pens, postit's, etc.)? We did receive our sweatshirts today. Thanks so much. They are really nice, Thanks for your support with this, We hope it brings a lot of referrals, UM CAFE 0565 Printed for Jeannie Kenney 9118/03 I =eAmy. VandenEynden@quintiles.com, 02:05 PM 7/14/03 -0500, Re: CAFE-Amendment 2 approvals To: Amy. VandenEynden@quintiles.com From: Jeannie Kenney ‘Subject: Re: CAFE-Amendment 2 approvalsirevised ICFs Ce: Bee: Attached: J:\Olson's trils\CAFE\Consent Forms\Adolecent Assent\VADOLESCENT 03-25- 03.doe; J:\Olson's trials\CAFE\Consent Forms\Adult Consent\adult 3-25-03 doc: J:\Olson’s trials\CAFE\Consent Forms\Parental Consentiparental 03-25-03 doc: Hi Amy, Attached you'll find the most recent ICFS. The IRB really got mixed up with approving the Protocol change and so it wasnt unl actually just this last week that we rec'd final approval ‘They approved the consents before approving the protacol. | now need to go back and have everyone else sign new consents so they are offcially informed of the protocol change. I be faxing the IRB approval letters asap. If you have questions, let me know. ger ~eomtecmer Jeannie AL 12:28 PM 7/11/03 -0500, you wrote: Hie 3 Can you please fax a copy ot your amendment 2 approvals and revised ICFs ‘They need to have these in the central fie! Thanks- Amy fax- 513-731-2159 sreeeeeeeeseMPORTANT-PLEASE READ trteveessenseee This electronic message, including its attachments, is COMPANY CONFIDENTIAL and may contain PROPRIETARY of LEGALLY PRIVILEGED information. Ifyou ere ‘not the intended recipient, you are hereby notified that any use, disclosure, Copying, or distribution ofthis message or any ofthe information included in tis unauthorized and strictly prohibited. If you have received this, message in error, please immediately notiy the sender by reply e-mal and permanently delete this message and its attachments, along with any copies ‘hereot If this electronic message contains a zipped attachment and you do ‘not have a decompression tocl, you may download unZIP (free of cost) from. ‘ito. mk-net-work.convus/uzlunzip.him, Alternatively, you may request {hat the attachment be resent in an uncompressed format. Thank you Printed for Jeannie Kenney 7 UM CAFE 0582 oy aJennife.|frante@quintiles.com, 10:04 PM 6/4/03 -0400, RE: Request for funds Page 1 of 5 X-From,_: jennifer | frantz@quintiles.com Wed Jun 4 21:12:42 2003 X-Umn-Remote-Mta: [N] mhub-w5.te.umn.edu #LO+NM, XYma-Remole- Mt: [N} mail quintiles.com ##NE (I) X-Umn-Report-As-Spam: hitp:/lumn.eduimels? BMnciQkQgTAS7AehwZbbhgk2 1d4KoFBY HanrsHhRNw Subject. RE: Request for funds To: Jeannie Kenney From: jennifer. frantz@quintiles. com Date: Wed, 4 Jun 2003 22:04:21 -0400 7CMIME Track: Seriaize by Router on QNEWLNO1/QNEW/Quintiles(Release 5.0.5 [September 22, 2000) at 06/04/2003 10:04:54 PM, itemize by SMTP Server on GRTPLCOZ/QRTP/Quintiles(Release 5.0.11 [July 24, 2002) at 06/04/2003 10:12:22 PM, MIME-CD by Router on QRTPLCO2/ORTP/Quintiles(Release 5.0.11 {July 24, 2002) at 06/04/2003 10:12:22 PM, MIME-CD complete at 06/04/2003 10:12:22 PM, : Saalize by Router on QRTPLCO2IORTP/Quinties(Release 5.0.11 July 24, 2002) at 06/04/2003 10.12:36 PM Hi Jeannie, ‘This is no problem, AZ has given the okay for this pt and the associated transportation costs. This is the template | made up for another site they were tracking mileage, you can edit it to describe car service Please include the visit number and round-trip cost. (See aitached file: mileage reimbursement template xls) Thanks, Jen Jeannie Kenney on 06/04/2003 11:59:28 To: jennifer. frantz@quintiles com cc Subject: RE: Request for funds Depending on the mileage it would be between $30 - $50. One of out ether studies is using this service. It was more cost efficient than cab fare and it's more comfortable as the clients are picked up in pretly nice vehicles. Kind of makes them feel important Jeannie At 11:44 AM 6/4/03 -0400, you wrote: UM CAFE 0594 Printed for Jeannie Kenney 615/03, 8UNIVERSITY OF MINNESOTA Ambulatory Research Center Department of Pychiary Riverside Prfesions Building ey 04-2 Avene Saath oc Sue 602 Minscopots, MN S805 April 25, 2003 Quintiles, Inc. Mary Ann O’Herron 10201 Weteridge Circle San Diego, CA 92121 Dear Mary Ann, Please find enclosed a receipt for refreshments. Our CAFE team presented information about the study ata private psychiatric outpatient cline in the area. It was nice to provide thisto them as @ way to acknowledge the time and attention they gave us over thet lunch hour. ‘Thank you for processing this request. The staf person who purchased the food for this function is Elizabeth Lemke. Ifyou have further questions, please feel free to contact me at (612) 627-4363, Sincerely, L Mao 12). Kean dean M. Kenney, LICSW CAFE Study Coordinator UM CAFE 0610 we 4Monica Pallett, 11:21 AM 4/15/04 -040...: [cafese] CAFE PANSS Rater Certification Statu Page 1 of 3 X-From_: monica_pallett@med,unc.edu Thu Apr 15 10:22:13 2004 X-Umn-Remote-Mta: [N] mhub-m6.tc.umn.edu [160.94.23.36] #+LO+NM X-Umn-Remote-Mta. [N] zebulon.med.unc.edu [152.19.4.47] ##NR+UF+CU (A) X-Umn-Report-As-Spam: To: "Jeannie Kenney" Subject: RE: FW: [cafesc] CAFE PANSS Rater Certification Status Date: Thu, 15 Apr 2004 11:21:43 -0400 X-Mailer: Microsoft Outlook, Bulld 10.0.2627 Importance: Normal | did receive Christa’s “Jose" score sheet | don't have one from Angie Guimaraes ot John Vuchetich yet, though, Relibilty is assessed for each year by analyzing the three Scores of that year together What we do with incividval retabiity tapes is look al the scores and any one who is more than 20 points out will be asked! {0 Fescore now (unless it's keeping with an overall rend of scoring high cr low) "Jose" isthe fst of three for year 3 relibilty, the 2" tapé #26 is being sent out this week. If you don't hear fram me aller scores are. Submitted assurne that no news is good news, Thanks, Monica s---Original Message— From: Jeannie Kenney {maito:kenne097@umn.edu] ‘Sent: Wednesday, April 14, 2004 12:30 PM To: Monica Pallett ‘Subject: RE: FW: [cafesc] CAFE PANSS Rater Certification Status Hi, | went back and saw that in September of last year Dr. Olson was reminded that he was only certified for CATIE PANSS,not CAFE and that he would need to view the vignettes online. Looks like he did not do that. I have reminded him of this. I'm glad I save all of my e-mails ‘ble I don't have the best of memories. Sorry about the confusion from this end, Jeannie PS. Also, Christa Surerus-Johnson sent in her Jose tape. Have you received Angie Guimares or John Vuchetich's yet? Also, will we receive results as to if we pass recertification? JeannieAt 10:10 AM 4/13/04 -0400, you wrote: ‘That is not possible as only one of the three tapes, Josephine , was viewed at the investigator s ‘meeting I ve checked the excel spreadsheet that was handed aver to me wien | took over the CAFE ‘Assessment Unit and also checked the hard copy files and have no record of any CAFE PANSS tapes Being raled by Dr Olson. Unless you can produce his orginal score shee, |wil need him to score the CAFE cartiication tapes They are on the CAFE website, or VHS tapes can be sentif needed Thanks, Monica UM CAFE o666 Printed for Jeannie Kenney 4115104Mr pica Pallet, 11:21 AM 4/15/04 -040..: eafese] CAFE PANS Rater Certification Stat Page 2 of 3 Jeonnie Kenney [mailto:kenne037@umn,edu} ‘Sent: Friday, April 09, 2004 11:34 AM To: Monica Pallett Subject: Re: FW: [cofesc] CAFE PANSS Rater Certification Status Dr, Olson was certified to rate PANSS at the Investigator’s meeting. Jeannie At 10:11 AM 3/30/04 -0500, you wrote: Hi Jeannie, Br Olson has not viewed the Jose tape and stil needs,to do so for CATIE. However, he has never become cerified as a PANSS rater for CAFE and therefore should NOT be rating fe PaNoS foe EAE {ihe is doing so, or plans to do so, he needs to go on the CAFE website and scars tree three tapes ASAP (fax one page Score shact Io me at 919 849 7357) Thanks, Monica Original Message: Erom: Jody Robertson (mailtoJody_Robertson@med,unc.edu} ‘Sent: Thursday, March 25, 2004 10:18 AM To: ‘Monica Riedy Pallett” ‘Subject: FW: [cafesc] CAFE PANSS Rater Certification Status Does he? ~—~Original Message-—— From: Jeannie Kenney [malto:kenne027@umn, Sent: Tuesday, March 16, 2004 5:05 PM To: Jody Robertson Subject: Re: (cafesc) CAFE PANSS Rater Certification Status, Hi Jody, don't believe Dr. Olson ever did Jose. He still needs to do the recert doesn't he? Jeannie UM CAFE 0667 Printed for Jeannie Kenney ansioa &e GMonica Pallett, 11:21 AM 4/15/04 040... [eafeso] CAFE PANSS Rater Certification Statu Page 3 of 3 At 11.06 AM 3/10/04 -0500, you wrote: Hello everyone, Please see the attached list of PANSS raters by site, who are not curently certified forthe PANSS. Also listed ar the items that are outstanding. Please see that all sters compete the PANSS on-line certification as soon as possible. Feel free to contact Ismail Abdeldicke (gipweed@email unc.edu) if you have any difficulties with the CAFE website ‘Thank you, Jody Robertson Department of Psychiatry University of North Carolina at Chapel Hill Phone: 919.843 2420 fax 919 843 7859 ager. 919 216.0898 ‘You are currently subscribed to cafese as: kenneO97@ymn edu ‘To unsubscribe send a blank email to leave-cafesc-1433002N@listserv unc edu UM CAFE 0668 Printed for Jeannie Kenney anis/os =e 7UNE SCHOOL OF MEDICINE : DEPARTMENT OF PSYCHIATRY MEMORANDUM TO: CAFE Investigators and Staff FROM: Jeffrey Lieberman DATE: December 15", 2003 RE: CAFE Enrollment Kickoff Dear Colleagues, Ine have now worked together onthe CAFE project fr almost two yéars. Our common goa sto coniplete the study successfully and provide data that will answer critical questions about the wee of atypical ayeesy bode drugs in patients in ther frst psychotic episode. hank you for your superb effin ia making Ubi tal posoible and successful to date. Although recruitment has recently gone quite well we cid os cars diy Tsk for not meeting ur target of 400 subjects. As of Sunday, November 30%, 2003, we hace cored 324 subjects out of our target 400. There are only 13 weeks left to enoll subjects and thoes vy Fossbiiy of further extending the enrollment period. We have been averaging 20 new subjects creo vor 2 ast G months now but we need to enrll about 25 per month for the remainder of the tral ewok nc Se UOd | Patent per month in the maining 3 months then we will meet our gal 1 encourage youto make every effort to enter patients into CAFE in this final stage of enrollment. With a little extra effort, we will succeed Best Wishes to All for @ Happy Holiday and Healthy New Year, Jeffrey Lieberman ‘The Universi of North Carolina at Chapel Hu Campus Box 716, Chea Hl, Noth Celina 27599-1160 Telephone: (919) 946-8996; FAX: (19) 06-8994, EMAIL Menno UM CAFE 0677 gyUNIVERSITY OF MINNESOTA tection Pengrams Mev Mat Code 820 D528 Mayo Meneoral Badin Jnsitational Review Board: Hunan Sujets Commie IRB) ¢ ; paearhcirs 220 Delovare Sree $B Insisutonal Amal Care cd Use Commie ACCC) Meee ee 612-8265 Fax. 612.626.4061 August 06, 2002 inb@uen ede ‘acue@ unm ede Ing ten esearch ned Timothy W. Olsen Subjects hi Ophihalmology Box 493 Mayo Minneapolis Campus Twin Cites Compur Researeh Subjects Py Re: "An Evaluation of Efficacy and Safety of Posterior Justascleral Injections of Anecostave Acetate 15 mg (0.5ml of 30 mg/ml Anecortave Acetate Sterile Suspention) Versus WISUDYNE in Patient with Subfoveal Exudative Age-Related Macular Degenaration » (AMD) Eligible for Initial Treatment with Photodynamic Therapy (PDT) Using VISUDYNE Human Subjects Code Number: 0206126801 This correspondence replaces my lener dated August 01, 2002 Dear Dr. Olsen: At its meeting on July 31, 2002 the IRB: Human Subjects Committee reviewed your response to its deferral and approved the referenced study (protocol dated May 3, 2002). For grant centifeation Purposes you will need that date and the Assurance of Compliance number which is FWA00000312 (Fairview Health Systems Research FWA00000325), Approval for the study will (fbire one year from that date. A seport form will be sent two months before the expiration date. Xf you would like us to send cenification of approval to a funding agency, please provide the narge and address of your contact person at the agency. The code number above is assigned to your research. That number and the title of your study Should be used in all communication with the IRB office. IRB approval of this study includes the consent form dated 07/12/2002 and recruitment materials received on June 11, 2002, The IRB notes that the use of drugs/biologics!devices in this study is carted out under IND #56595 and IDS #2266RO. The IRB would like to stress that subjects who go through the consent process are considered enrolled participants and are counted toward the total number of subjects, even if they have no further participation in the study. Please Keep this in mind when caleulating the nuraber af subjects you request, This study's currently approved for 200 subjects. If you desire an increase in the number of approved subjects, you will need to make a formal r DEPOSITION a. EXHIBIT Olaalra UM IRB 0324As Principal Investigator of this project, you are required by federal regulations to inform the IRB of any proposed changes in your research that will affect human subjects. Changes should not be initiated until written IRB approval is received. Adverse events shor ld ce reported to the IRB as they occur, Research projects are subject to continuing review and renewal Ifyou have any questions, please call the IRB office at (612) 626. 3654 On behalf of the IRB, I wish you success with your research Si rely, ‘rol Siegel, MES, eX Assistant Director CSiki . CC: Sally Cook, Bric Steuer UM IRB 0325Comparative Effectiveness of Antipsychotic Medications in Patients with Schizophrenia Consent Amendment Comparative Effectiveness of Antipsychotic Medications in Patients with Schizophrenia (The CATIE Study) Sponsor: National Institute of Mental Health eee The U.S. Food and Drug Administration has issued a new warning about an increased risk of hyperglycemia (high blood sugar) and diabetes mellitus in persons taking the antipsychotic drugs aripiprazole, clozapine, olanzapine, quetiapine, risperidone, and ziprasidone, all of which are used in the CATIE tral. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued, however, some patients still needed anti-diabetic treatment after stopping the atypical antipsychotic drug. In rare cases hyperglycemia is associated with ketoacidosis (high levels of acid in the blood), coma, and death, The new warming does not apply tothe other CATIE study drugs (perphenazine and fluphenazine decanoate) but all persons with schizophrenia are thought to be at increased risk of hyperglycemia and diabetes mellitus compared to the general population In the CATIE study we are monitoring your blood glucose quarterly with a fasting blood glucose 2st anda test called Hemoglobin Ale. ‘Symptoms of hyperglycemia include excessive thirst and irinking, increased urination, increased appetite and eating, and weakness. If you develop any of hese symptoms let your study doctor know as soon as possible. You will be asked to undergo ‘sting blood glucose testing. Your doctor will then discuss options with you and make reatment recommendations, These recommendations may include referral toa general medical doctor, stopping the study medication, and starting anti-diabetic treatment. The tecommendations may also include suggestions about diet and exercise. If you have risk factors for diabetes mellitus (e.g, obesity, family history of diabetes), please advise your study doctor As always, your participation in this study is voluntary. You can refuse to participate or withdraw from this study at any time, without penalty Subject's Acknowledgement: Thave read and understand the information provided above, ——— — Signature of Research Subject Date Printed Name of Research Subject SCH O111M12742 Page 1 of 1 UM CAFE 3146 Version Date: April 5,200Jennifer | frantz@qui../04 -0500, [eafesc] FDA's Waring about hyperglycemia and diabete Page 1 of 2 X-From,, bounce-cafesc-1433002@listserv unc.edu Mon Mar 15 11:17:08 2004 X-Umn-Remole-Mta: [N] mhub-m6 tc. umn.edu #+*LO+NM X-Umn-Remote-Mta: [N] lambada oit unc.edu #+NE+NR*UF+CU (A,-) X-Umn-Report-As-Spam. ject. [catesc] FDA's Warning about hyperglycemia and diabetes To: “cafe study coordinators" From. jennifer frantz@quintiles. com Date: Mon, 15 Mar 2004 12:14:47 -0500 X-MIMETrack: Serialize by Router on QNEWLNO1/QNEW/Quintiles(Release 5.0.5 [September 22, 2000) at 03/15/2004 12:15:18 PM, Itemize by SMTP Server on QRTPLCOZORTP/Quintiles(Release 5.0.11 [July 24, 2002) at 03/15/2004 12:16:58 PM, MIME-CD by Router'on GRTPLCOZ/ORTP/Quintiles(Release 5.0.11 July 24, 2002) at 03/15/2004 1216-59 PM, MIME-CD complete at 03/15/2004 12:16:59 PM, Serialize by Router on GRTPLCO2/GRTP/Quintles(Release 6.0.11 [July 24, 2002) at 09/18/2004 12.17.01 PM List-Unsubsonibe: 2 Ya! Kort arma “Ap ny, CAFE schedule of events provides adequate monitoring for hyperglycemia and diabetes according to the ADA's guidelines. As a reminder, please submit any revised consent forms to Quintiles before submitting them fo your IRB for approval. Best Regards, Jen {AZ Wording for Addon of Hyperglycemia and Diabetes here have been reports of hyperglycemia and diabetes in patients treated with the CAFE study medications, You may therefore be UM CAFE 3113 Printed for Jeannie Kenney sn7i04 ~ 4jennifer | frante@quintiles.com, 05:06 PM 4/30/04 -0400, [cafesc} All Cause Treatment .. Page 2 of 3 2c. If the clinician and the patient agree that study medication should be discontinued by convention this is considered a clinician decision, 3, Patient Decision should be chosen if the subject decides to discontinue study medication against the clinician's recommendation. Lost to follow up should be considered a patient decision. Suicide, by convention, is also coded as a patient decision. 3a. A patient decision cannot have a primary and secondary component. Please also note that the following subjects that will be included in the data transfer will have EOS queries. Therefore, these queries need to be resolved as soon as possible after they are issued 00160002 00210008 00220020 00100002 00250004 0250008 00250014 00270002 00270003 o0g0001 ooos0003 00020007 00030008 ooo4o002 ooo4o009 oa80007 00720003 00140001 00150017 00170008 00180013 00180014 00180017 00180045 00180048 00190003 00230011 00250002 00250013 00050002 ‘Thanks for your help in completing these very important queries. Have a great weekend. Jen ssseeeenseetsss4 PORTANT PLEASE READ *Ytteteseasete UM CAFE 3133 Ss~~ UNIVERSITY OF MINNESOTA Invoice #4 Date: o7/11/02 Uof M Acct #. 1743-645-9031 ‘Tax Identification #: 41-6007513, ‘Award Amount: $251,237.00 Payeats Nan and Ross taka Check Paya University of Minnesota Ain: Paymonts Mai Check Quintiles, nc University of Minnesota 10201 Waterige Circle Sponsored Financial Reporting San Diego, CA2421 200 Oak Street SE, Suite 450 L i ___| minneapots, mn 8485-2070 Protocol #:os77iL 10114 Tie: Etficacy and Tolerability of Olanzipine, Qutiapine and Risperidone in Treatment of First Episode Psychosis: A Randomized Double Blind 82 Week Comparcen Principal Investigator Stephen Olson July 11,2002 |Per Agreement Due Upon Iain of Stuy 16,262.00 Independent Review Board Fees 1500.00 I TOTAL ANOUNT DUE |} —“Ti.5600 PAYABLE WITHIN 30 DAYS, | certify that to the best of my knowledge and belie, all expenditures reported (or payments requested) {are for appropriate purposes and in accordance with the agreements set forth in the application and award documents. Vw at. ¢ On Norah Ochmike, Fiscal Offeer Preparers Name and Phone Number: Sponsored Financial Reporting i heer Haris 612-624-4038 UM SPA 0437Sponsored Projects Administration Troe jrosvos2.*] Notice of Grant or Contract Award omer riack ts: | i Paymeré Frequency Schedule of Payment: ‘SFR a clon ‘Ste.ssz00araina tees REPORTING REQUREMENTS Repering Frequency: [ soeney (i ee Adress 1: 10201 weterpe Gicle Address 2 ow: Overt: ibs SS ert Nes Fonds mast * comsnareRennteg: io | Cost Share Aco Gd cea Te gos Wo projac win Unerly of Minnesota guiedires. | Can nar caste beaw amine be] Fj} Can FAA wetter eps tarFaSY Contac Fem po” ] ASDA pe | Par Paya | Budget pd ond ca Tl Prec ena catetrocestentson: ‘SmallSmal dsadvartanea business eparing recueea(>$500.000% ne [MBENBE reporng resid (EPA ony | i Pree UM SPA0075, geAmy VandenEynden@quintles com, 04:00 ./03 -0600, CAFE Study Updates- Please Rea Page 1 of 3 X-From_: Amy. VandenEynden@quintiles com Fri Feb 28 16:02:33 2003 Subject. CAFE Study Updates. Please Read Sen: To: “Amawi, Lana’ , Jeannie Kenney , ‘Shannon Knepfie , Kimberlee Hansen , Shannon Knepfle From: Amy. Vanden€ynden@aquintiles.com Date: Fri, 28 Feb 2003 16.00.49 -0600 XcMIME Track: Serialize by Router on QKANLNO4/QKAN/Quintles(Release 5.0.11 uly 24, 2002) at 02/26/2003 04:01:48 PM, ltemize by SMTP Server on QRTPLCO2/QRTP/Quintiles(Release 5.0.11 jJuly 24, 2002) at 02/28/2003 05:01:29 PM, “MIME-CD by Router on QRTPLCOZ/ORTP/Quintiles(Release 5.0.11 [July 24, 2002) at 02/28/2008 05.01.30 PM, MIME-CD complete at 02/28/2003 05:01-30 PM, Serialize by Router on QRTPLCOZ/ORTP/Quintiles(Release $.0.11 \luly 24, 2002) at 02/28/2003 05:02:09 PM X-Umn-Report-As-Spam: hitp./Jumn.edulme/s? BL LYVW.DaViiUyXD4VRnwSFVbYRcY2Vqb8YfigBUNPc X-Umn-Remote-Mta: [N] ns3 quintiles.com # (1) X-Umn-Remote-Mta: [N] mhub-m4 te umn edu #+LO+TR+NM (Embedded image moved to file: pic22813 pcx) Important Updates Prior Anti-psychotic treatment: Because itis often difficult to quantify the exact duration of and compliance with prior prescribed antipsychotic treatment, we will now be considering patients with up to 24 weeks of prior {treatment with an antipsychotic for inclusion in CAFE. Please contact Dr McEvoy on a case-by-case basis to request approval for a protocol deviation in patients who may have had more than 16 weeks of prior antipsychotic treatment. In order to enhance patient safety and well being, we will also Consider requests for approval of protocol deviations to allow patients to enter CAFE while taking adjunctive antidepressant mood stabilizing drugs. In ail such cases, send a brief email to Dr. McEvoy at jpmcevoy@duke. edu with 8 copy to Jennifer lfrantz@quintiles com Recruitment Efforts In an effort to assist you in your recruitment efforts, @ monetary allowance is being made available to you to provide food and beverages at functions that serve as a forum to recruit subject for the CAFE study UM CAFE 3191 Printed for Jeannie Kenney y 2128/03 é‘Amy. VandenEynden@quintiles.com, 04 00 _/03 -0600, CAFE Study Updates- Please Rea Page 20f 3 Your site would be reimbursed an amount up to $100 over each 3 month Period. Quintiles will pay on behalf of AstraZeneca for reasonable costs upon review and receipt of an invoice. Please forward invoices to Quintiles, ine Attn: Mary Ann O'Herron 10201 Wateridge Circle San Diego, CA 92121 Some suggestions for forums in which to provide informational meetings: Other focal outpatient clinics, Mental Health Clubhouses in your area, social work agencies that deal with the mentally il, homeless shelters and outreach programs, contacting the assessment units! screening units of state agencies (Departments of Mental HealthiHuman Services) that provide services to this population, Here in the Northeast, state budgets are on the chopping block and the human service sectors are often the first to be impacted. This study may provide @ well needed resource in a time of economic uncertainty Updated Study Contact List- Please file within your regulatory binder (See attached file: Contact List 02-03 doc) Clarification for the dating all cause eatment discontinuation al lln the case where the study | The date of discontinuation | medication is abruptly discontinued|(DOD}would be the last day the i subject took I i | medication I | Inthe case where a patient is [DOD= the first day that the | |eross-titrated from the study |cross-titration was initiated (even | |medication to another medication if the patient I | continued on study medication for | [several days or longer as the | |eross-titration was completed). | jould be the date that the | | In the case where a patient [DOD: independently decides to discontinuelpatient actually stopped taking | Imedication prior to coming in for a medication. Note that all. available| Istudy [information can be used to determine| | Ithis date, including patient. — | | Ireport, pill counts, and family | | Imember reports. 1 I 1 lin the case where a patient is lost | DOD= the day that the patient would] [to follow-up and date of medication|have run out of medication Note | Idiscontinuation can not be obtained |that information from family member] [from the patient or family. Jor friends can be helpful in| | Jobtaining a more accurate date, for | UM CAFE 3192 Printed for Jeannie Kenney 2728/03 aoa‘Amy VandenEynden@quintiles com, 04 00 . /03 -0600, CAFE Study Updates- Please Rea Page 3 of 3 | [example if the family member says | | [the patient left town, and left the | I Ifull study medication bottle behing | lin their room, then the date of || I medication discontinuation would not} i linclude the possibility thatthe | I [patient had taken those pills. | I When entering information into the MetaTrial system, the system will display an error message if the dale of treatment Giscontinuation/completion does not match the visit dale The following will appear "The date of study discontinuation/completion does not maich the visit date. Please re-check”. Please disregard this message if the date does not match dué to one of the circumstances listed Please contact Joe McEvoy or Diana Perkins if there are any questions about how dating should be done in particularly complicated cases (e.g when the patient is intermittently adherent to medication} (Embedded image moved to file: pic9514.pex) Data Eniry Please ensure that data is being entered promptly after each subject visit. Please contact me with any questions. Thank you Amy VandenEynden Sr. Clinical Research Associate 513-533-1306, (See attached file: pic22813 pcx) (See attached file: Contact List 02-03 doc) (See attached file: picd9514 pcx) pic22813,pcx ontact List 02-031.doc pic09514.pex UM CAFE 3193 Printed for Jeannie Kenney 22503 9 oydanielle simons@auintiles com, 09 21 06/13/2002 -0400, Re: CAFE ..: Contact Informatio Page 2 of 2 feels a bit overwhelming to step up and say, "yes, 'm the one to direct questions to". I've reed the protocol but wonder if there is also a training guide that may be of help. Also, is there any on-line training | should be doing to become competent in doing the many assessment scales, etc.,? ‘What is the next step from here in getting things up and running? Will we be receiving materials? I'm anxious to formally start recruiting My contact information is as follows: Jeannie Kenney University of Minnesota Depariment of Psychiatry Riverside Professional Bldg 606-24th Avenue South Suite 602 Minneapolis, MN 55454 Phone. 612-627-4840 Fax 612-627-4808 You can reach Elizabeth at the above as well, Thanks. On 41 Jun 2002, danielle. simons@quintiles.com wrote > Hi Jean > Dr. Olson forwarded me your neme as the new primary Study Coordinator for > the CAFE Study. Welcome to the study! | am the clinical assistant and > will be working with you to finish up the regulatory/IRB requirements so > that your site can hopefully start enrolling soon. If you could send me > your contact information (phone, fax) | would appreciate it! Since you are > the primary Study Coordinator is it correct that you are the first contact > for any questions or CAFE related information? if you have any questions > please feel free to contact me at 908-956-2232! > Have a good night! > Danielle > Danielle Simons > Senior Clinical Assistant > Quintiles, Inc.-QNEW > Phone: 908-956-2232 > Fax 908-653-0108 UM CAFE 3028 Printed for Jeannie Kenney 06/14/2002 Il‘webmail message view: Re: CAFE questions Page 2 of 2 Me T have 6 few more questions regarding the CAFE trial. A. Dr. Olson's site received study drug, but Jeannie (study coordinator) doesn't have an 1VRS password. What does she need to do to get one? 2. Olson's site wants to make sone sort of prees release combining CAFE and CATIE. Ts there » tonplate created yet or do you have # short sunmecy gf the trial rhat they could use for flyers? 3. Has @ contact 1ict bean sent to the sites? ‘Thanks, aay (See attached f11e: pico0041.pex) BRS. 28 Ye St, BBO UM CAFE 3003 baps://worw5.mail.umn.edureadmsg,phpmailbox=+Hn-Boxéeuid=569 enpgn002‘webmail message view: Re: Consent Versions 6-26-02 + at sey of ef ae From T Te: T andeas23 i T eteabeth Lemke T erenneasr@umn ea T stephen Olson Subject _ Rp, Consent Versions 6-28.02 Date Yardunta $ 04pm {@)=7s0-0859-1207CKFE Aporovel LTR doe?= (anpicationsward 1 2Q7CAFE_ sponser Ch 6:26.02 d007= Atochments Bx7s0-0050-170?Paretal consen\ = 6-28-02 d02?=(applcaloniswats) #2) =2)0-8859-1207Adul 6-28-02 doc? (appl e wt mise T looked over everything and it locks goad! The email version was very easy to open. Thank you for taking care of it so quickly..-If you nave any Cther questions please let me know! Have a good day! Danielle ande3$23 on 06/27/2002 15:59:57 10 €ci danielle. simons@quintiles.com, Elizabeth Leake , kenna091@unn-edu, stephen Olson Subject: Consent Versions 6-26-02 Hi Danielle, T thought I'd try something different from the everyday fax and attach these viz enail. Let me know if this is easy to open or a real paint Bnclosed are 2 copy of the letter we're sending to the IAB with the consents, 2 copy of each of the two consents including the stipulations you'd suggested, and a copy of the Letter we sent £0 the IAD along with a Copy of cur site approval letter: Noxt on the docket then is recruit, recruit, recruit! This is so exciting thank you so mich or everything you've done so far to get us going! Elise s+ esate server ORTPNT31 scanned this email for malicious content ++ (See attached file: CAPE Approval LTR. doc} (See attached Cile: CAFE spenser changes to Consents 6-26-02.doc) (See attached file: Parental consent = 6-26-02 dec) (See attached file: Adult 6-26-02, doc) UM CAFE 3006 Ittos/fwweS.mait umn edu/readmsg php?msilbox=+n-BoxSiuid=563 ‘7102/2002 v BAmy VandenEynden@quintiles com, 05.00 PM 1/27/03 -0600, Re CAFE Page 1 of 3 X-From_: Amy. VandenEynden@quintiles.com Mon Jan 27 17:00:24 2003, Sensitivity Subject: Re: CAFE To: Jeannie Kenney From: Amy VandenEynden@quintiles.com Date: Mon, 27 Jan 2003 17:00:17 -0600 X-MIMETrack. Serialize by Router on QKANLNOA/QKAN/Quintiles(Release 6.0.11 [July 24, 2002) at 01/27/2003 05:00:21 PM, ltemize by SMTP Server on GRTPLCOZ/QRTP/Quintiles(Release 5.0.9 |November 16, 2001) at 01/27/2003 06:00:09 PM, Serialize by Router on QRTPLCO2/ORTP/Quintiles(Release 5.0.9 [November 16, 2001) at 01/27/2003 06:00 16 PM, Serialize complete at 01/27/2003 06:00:16 PM X-Umn-Report-As-Spam: htto-/lumn.eduimcis? BfetstoowXJwPH) laeM@s6UxJSleaRORs 0 X-Umn-Remote-Mta: [N} mail2.quintites com # (I,-) X-Umn-Remote-Mta’ [N] mhub-c4 tc umn edu #+LO+TR+NM It sounds like you have a good amount of leads/potentials. Hopefully your hard work will start to pay off soon! The specially inpatient unit sounds like it will help out a fot with recruitment!! Definitiey call about the 41 year old. everything is worth a call Like | said, let me know if you think of anything that could help you out with recruitment.....you will know what you can benefit from more than { : do! Take care and try not to get too frustrated! Amy : h Jeannie Kenney on 01-27-2003 16.47.17 To: Amy VandenEynden@quintiles.com ce: Subject’ Re: CAFE We ate getting more info out and are still waiting for our IRB to approve the newest CAFE recruit info. | am going to be screening a 41-year old man 80 if he meets criteria on the SCID will have to get the ok to take someone at age 41 (the cutoff is 40). UM CAFE 2959 re Printed for Jeannie Kenney 23103Amy. VandenEynden@quintiles com, 05:00 PM 1/27/03 -0600, Re: CAFE Page 2 of 3 The last young woman who was referred from inpatient would have benefitted so much from this study. | put in a lot of time, meeting with the case manager and attended the discharge planning meeting. | thought the parents were interested. | do have her scheduled with Dr. Olson for outpatient med management so perhaps we can gain their trust and offer it as an option again. am organizing a family education series for the community and hope that this will also get the word out about the University and our schizophrenia program, Ill attach a copy of the flier. It wll not specifically deal with research but I'm sure it will be brought up as a treatment option. Also, the hospital is opening a psychosis specially inpatient unit first of April. Dr. Olson and | are very much involved in the planning so will have closer contact with first episode people who come in. We are really hoping to promote state-of-the-art care and potential for research is part of the programming. in fact, it will be discussed in the interviewing of staff so it will be nice to have a treatment team fully on bodrd with what we are doing in the department Thanks for letting me ramble. | really do think our efforts will pay off. I just hope soon! Jeannie At 16 33 01/27/2003 -0600, you wrote >Hie >| can understand that you are frustrated! Do what you can with subject >002.....please call if the subject gets out of window bic there is always >the possibilty of granting exceptions. if | am not available, contact > Jennifer Frantz >As for recruitment, have you had any luck with any of the area facilities? =I thought you mentioned that you go to area sites and give them information. 1s there anything that we can provide to help with this? >Jeannie Kenney on 01-27-2003 16:06:17 >To: Amy VandenEynden@quintiles com >ee >Subject Re: CAFE >Hi Amy, UM CAFE 2960 >Having trouble with Subject 002. His sister just died, his father has 5 Printed for Jeannie Kenney 2/5/03Amy VandenEynden@quintiles com, 05 00 PM 1/27/03 -0600, Re: CAFE Page 3 of 3 >terminal cancer and now the grandmother is sick. He missed a visit and now >just missed the next one. | hope I can get him in for the allowable window >for the visit he missed Friday. | understand the situation is really difficult but am afraid we might be losing him when his family thinks he >probably needs this treatment now more than ever. Have had another person > show interest from inpatient and then the parent put the pressure on and >said, "NO" (3rd time this has happened) Have tried to ask about concerns, >etc, but usually just get a NO. So, some frustration here bic we really >need to get more enrollees, We've had none for January and that concerns >me a lot >At 15:45 01/27/2003 -0600, you wrote: > >Hi- > Just checking in to make sure everyone is doing ok. | am going to be > >sending weekly emails just to check in, so please feel free to email me or > >call me with any issues that you are having with the tral. > >Thanks- > >Amy > >513-533-1306 >Jean M. Kenney, MSW, LICSW >Ambulatory Research Center >Department of Psychiatry >University of Minnesota 606 24th Avenue South, Suite 602 >Minneapolis, MN 55454 >Phone. 612-627-4809 >voicemail: 612-627-4363 Jean M, Kenney, MSW, LICSW Ambulatory Research Center Department of Psychiatry University of Minnesota 606 24th Avenue South, Suite 602 Minneapolis, MN 55454 Phone: 612-627-4809 voicemail. 612-627-4363 UM CAFE 2961 Io Printed for Jeannie Kenney 213/03EMERGENCY CONTACT INFORMATION ‘Concerns During Daytime Hours Jennie Keaney 612-627-4363 De Stephen Olson 612.273.9765, Direct Urgent Questions After Hours Jeanie (Fuge) 612-899-5080 Dr Olson (Pager) 612-899-7512 Please contac Fairview University Medical Center in ease ‘ofan emergency (612-672-6402) or need for hospitalization (612-612-6600). A psychiatrist f avaiable 24 hours a day. CAPE sTUDY ‘The CAFE (Comparison of Atpieae for Firs Episodes) « short ie given t Trial SO77ILIOLI4 : “The Eficacy and Tolerability of Olanzapine, Queipine and Risperidone inthe Treatment of Firs pina Psychosis - A Randomized Double Blind $2- week Comparison” ‘This projectis sponsored by AstraZeneca Pharmaceutieals Participants are randomized to one ofthe above 3 treatment meatins and mas participate in this study up to 17 mooths. In eae ofa medical emergency please contact Dr. Stephen Olson. ‘Note: Lwould suggest using the above wording that reflects both che acryaym and trial name more prety ‘Would it be etter not to mention unblinding on this card butt simply contact the doctor? Please eal me with questions Tins 8056 3669 ext 63803, EMERGENCY CONTACT INFORMATION Concerns During Daytime Hours JeautieKeney 612-627-4363 Dr Steen Olson 612.273.9763 Direct Urgent Questions After Hours Sear (Paget) 612-495-5080 De Olsan (Pager) 12 Please contact Fairview University Medical Center in ese ‘of an emergency (612-672-6402 or need for hospitalization (612-672-6600, A psychiatrists avaiable 24 hours a day. CaF STUDY The Comparison of Atypicals in First Episode Pachoss ia double-blinded sty prt of the AstraZeneca Pharmaceuticals sponsored Efcacy ane Toleability of Olanzapine, Quetipine and Risperidone ine Teealnent of Firs Episede Psychosis Project Paripantsare randomized fo one ol te above eament mediation ad tty particpae upto 17 ‘months. The blind may be broken in eae of niedical ererpency by onlactng Dr. Stephen Olson, UM CAFE 2979/7jennifer | frantz@quintiles com, 10 15 11/21/2002 -0500, Re: Update of Consents Page 1 of 4 X-From_. jennifer frantz@quintiles com Thu Nov 21 09.22.02 2002 Subject” Re: Update of Consents To: Kenne097@umn edu Cc: Amy. VandenEynden@auintiles com From: jennifer | frantz@quintiles.com Date: Thu, 21 Nov 2002 10:15:04 -0500 X-MIMETrack. Serialize by Router on QNEWLNO1/QNEW/Quintiles(Release 5.0.5 |September 22, 2000) at 11/2112002 1015.29 AM, ltemize by SMTP Server on QRTPLCO2/QRTP/Quintiles(Release 5.0.9 November 18, 2001) at 11/21/2002 10:21:41 AM, MIME-CD by Router on QRTPLCO2/QRTP/Quintites(Release 5.0.9 [November 16, 2001) at 11/21/2002 10:21:41 AM, MIME-CD complete at 11/21/2002 10.21.41 AM, Serialize by Router on QRTPLCO2/QRTP/Quintiles(Release 5.0.9 November 16, 2001) at 11/21/2002 10:21'52 AM . X-Umn-Report-As-Spam. http //umn edufmels? BNUDBTTR4Y OcrA73txayhjoxBhehjTodU27bilm4WYOcANA, X-Umn-Remote-Mia: [N] mail2 quintiles com # X-Umn-Remole-Mla, [N] mhub-c4 te.umn.edu ##LO#TR Hi Jeannie, | made a blunder when | reviewed your consent and am really really sorry was using your ICF as an example last night when I noticed my error_ On page 4 on each of the consents (adult and adolescent), in the "During Phase 2..." paragraph. You added that bullet about measure vital signs...up 10 and including visit 12, visit 24, visit 52 and end of study. Those are the ‘weeks that the VS will be taken but not the visit numbers. Because the weeks were correct I didn't even think about it. It needs to be edited to read visi 9, visit 12, visit 19 and end of study. My hope is that your IRB already caught itor that it has not been reviewed yet. | don't think this should hold up eny patients at your site as long as you explain the procedures correctly and indicate it on the form that they sign while notifying the IRB of the mistake. | am_so sorry for any inconvenience this causes you. Thanks, Jen —— Forwarded by Jennifer L. Frantz/QNEW/Quintiles on 11/21/2002 10.10 — = Jennifer L Frantz 11/08/2002 08 03 To: Amy VandenEynden/QKAN/Quintiles@quintiles ce: UM CAFE 2986 18Amy.Vanden€ynden@auintiles.com, 12:52 08/28/2002 -0500, CAFE - Newest Protocol and consent To: Amy. Vanden ynden@quintiles.com From: Jeannie Kenney Siblect CAFE - Newest Protocol and consent changes Cc: danielle simons@quintiles.comm Bec: ‘Attached, Hello, [know that ou site ison holdfprobation for CAFE recruitment but | have some things | want to make sure I have updated. 2iso. | have the protocol with the minor changes highighted but | Wondered if there was a final c ‘copy that reflects the new date and version ofthe protocol Contd, You forward that to me as well ‘Thanks for your help. Jean Mt. Kenney, MSW, LICSW Ambulatory Research Center Department of Psychiatry University of Minnesota 606 24th Avenue South, Suite 602 Minneapolis, MN 58454 Phone: 612-627-4363 Printed for Jeannie Kenney akeaneoSi gee a Printed for Jeannie Kenney UM CAFE 2989 oy 4Coordinator call minutes ~ 9/12/02 ~ See attached site status grid, “Joe McEvoy ~ concommitant meds ~ We only want to record medications that are used regularly. Tn such a case, we want to know the median dose (the dose most commonly Ryeg), there ae any specific questions regarding concomitant meds, contact Dye McEvoy, ditferentiating AEs from minor ailments ~ One does not need to record the Gceasional, minor ailment. Also note, if the ailment is captured in anther assessment, it does not need to be re-captured. Q- What if a pt. reports an AE that is not related to the CAFE medication, but clinician disagrees? e A= Tell the pt. your opinion and talk about ways you will try to avoid sideveffects from occursing, but record pt’s answer, not clinician's, Q= Can we enroll apt. who has >4<5_months of previous treatment? A~ Yes, but document it and send Joe McEvoy notification Q=Ifitis the clinician’s best judgement, can ttation be done very slowly? A~ Yes, But aim for BID dosing and send Joe MeEvoy natifieation otheroise. Recruitment Tips ~ Go out to pt. facilites (specifically in-pt. units in the community and make staff aware of study. Give details, recruitment materials, and offer to came out ae assess any potential CAFE pt. Siivertse in tee papers. Directing the ads to both Dis, ad potential pts, © Stress the high quality care that pts will receive as @ perk to any referal DEPOSITION ari uh Ulaalir7 UM CAFE 0422Comparison of Atypicals for First Episode Study 50771L/0114 November 24, 2003 Stephen Olson, MD. University of Minnesota Medical School “Ambulatory Research Center (ARG) 608 24th Avenue South, Suite 602 Minneapolis, MIN 55454 usa RE CAFE study - 5077IL/0114 Dear Dr Olsen Caan ina 2 inform you that am no longer going to be working onthe CAFE tial Jennifer Martin, Sr CRA has been assigned to monitor your site, Jenna contac nformaton ss flows Jenifer Marin ‘208 Meroe rive Wodkesha Wi 8309 eaesores Jennie wl bn contact with tbe study contrat your ste inte rere to dacs tesa of ins} eyo ota welt sheds he nx mag tina ia ea oe Best ofc Sra, g (tag Vendy Cpe ‘Amy VandenEynden, St. CRA ce Astra Zeneca / UNC. Mentor Cental Fes Sponsored by Conducta by Incebraton wth Manages by 4“ = uke University Astrazeneca’? UNG Dale Une Ours ee orten — cae “2 UM CAFE 0553 aAmy.VandenEynden@quintiles.com, 04:37 PM 40/21/03 -0600, IRB letter To. Amy. Vandenynden@quinties.com From: Jeannie Kenney ‘ Subject: IRB letter Ge Bec: ‘Attached: C:\Program Fiies\QualcommiKemey\attachladmin change to protocol doc; FINALLY, FINALLY completed letter fo the IRB with administrative change to protocol and failure {to have those 3 subjects sign consent They are all signed now by the way. Also, have added 2 new person to 1572, She is a MSW student whom | am supervising. She has a great deal of Clinica experience and will be going thru CAFE training for the SCID, PANSS, ele. go she can assist with study visits. Do you want copies of this now or can it walt until your nex! visit? Irn Sure you will also need a copy of the signed letter to the IRB. Again, should | fax or mail those right away or wait? Hey, | met Jody Robertson ‘al this last investigator's meeting | attended in LV. She sald CAFE has picked two sites to be spotlighted for the next or-ine conference and that we are one of them, | guess ithas something to do with enrollment (improvement in our case) and retention and being referred to 2s a “good site, So, if you had any input on tha, thank you. We fos! pretty good about it Jean M. Kenney, MSW, LICSW ‘Ambulatory Research Center Department of Psychiatry Unwersiy of Minnesota, 808 24th Avenue South, Suite’ 602 ‘Minneapolis, MN 55454 Phone: 612-627-4363 Printed for Jeannie Kenney 7 UM CAFE 0563In Page lof 4 Subject: RE: Jody's address To: Jeannie Kenney Hi Jeannie, We can switch everything but drug. The drug shipment address must match an acidress on the 1872 exactly. If this address is on your 1572, we can Switch the drug as well, please just let me know, Jen Jeannie Kenney on 09/17/2003 13:37-36 To: _“Jody Robertson" , anier Lfrantz@quintle’.com>, , lexy, Christina” cc: “Elizabeth Lemke" Subject RE: Jody's address Thank you all very much for your generosity. | really hope we can givea report that we're getting 50 CAFE referrals out of this. Gotta think Positively. | will get the invoice together and forwarded to Maria asap, While 'm writing to this group | want to request that packages and correspondence comes fo my address at the University. We have fun into University of Minnesota Ambulatory Research Center Dept. of Psychiatry 606 24th Ave. S., Suite 602 Minneapolis, MIN’ 55454 Thanks again for all your support Jeannie At 04:31 PM 9/16/03 -0400, Jody Robertson wrote: Hi Jeannie, UM CAFE 0564 Printed for Jeannie Kenney 9/18/03 = 42, Recruitment information 3. Issues with protocol implementation Study S0771L/011 Seudy ofthe Efcacy and Tolerability of Atypical Antipaychote in Fst Episode Peychosi Comparison of rtypionts: fot Pits Episode CAFE Coordinator Teleconference AGENDA. January 8, 2004 1:00-2:00 p.m. EST Plalin number: 888-830-6260 Participant Code: 677078 1. Status ofthe study to date ~ As of January 7°, Site status: 26 sites active following new ste has been added: UT Southwestern in Dallas, TX Carol Tamminga, PI and Matt Byerly, sub-L Rhiannon Holland. study coordinator ') Enrollment to date 417 patients ensolled; 340 patients randomized; 120 patients discontinued; 20 patients completed Phase Il ©) Unresolved site problems 4) End of Study e-centficaton status and PANSS rater ce tification update 8) New ideas/requests 2) Questions re: protocol ) Questions re: Metatrial TOTAL seR RPAIS UM CAFE aeMinutes _1ol4p CE SS et = Tele confertice. 7 LSS aa ay Pacis af enrolled jE 2 (anomized OCF so fav = [2 nro CFE Fel ° randomize # Sram eo 4 Lom —— CenprailoFine- OS Caer Mes — FRE Wee rresendati ovis Univ Rosh. Cleveland ql [) Tek Community enka Neat Coders I Paucn ZR Moolle Das (2) Ofer — Depis_in Hesp inkendl Widen. @) Sake Hrosoutats (4) Work our ton weenhive: Plain (6) Advertise inant S Conger waich “NBRSAD NATE t Apptach jnos— Cet Tamil inl 671801188 Rev ve8 ASM Patient Progress Record Page 202 UM CAFE 0385 5 Kourory oaswar 05 p DEPOSITION s9ez-e¥8 (616) xe) : B9rs€%8 (616) ja) 0914-69922 ON ‘iH fadeu 8 BUM oouss jeBppaNy ber wo 0914 #80 ‘ewoAsa yo dod one e21u0H4 ‘que, 'B4¥D 40) asnseaw sig aye) 01 payieo tou 29 S03 OM) HOEY OL payse Osye sem | Ma hy Buymetnsejut our Aq Uononpos 1 an W pasoos ou pu (uot Sede} voyeaua9 ou jo Seal 199 SSNVe 2} YOY 0} au pase Apap uN Stu88s VY) Mo! OZ Dsi09s si9}es may e a BLLWO @ 288A) 319 40) 02 ade) Joy PIMOYS 0S Burop si By Bue Say ‘aluueer JeUuON :eoueyoduy, 4292'0°01 Pung “YooRNo Yososoiyy sialteWy-y 0080" z8:2S:01 €00z AON Z “U4 :areq S918 3.4Y9 joslang kouuayy euucy, — «Wore “OAT ESO TENTED UNM WRIST IUabERa Hee WN+O7+# npeuunoy gui £002 9F:85:60 2 AON U4 nparoun ed SISIEE IVS ‘O0SO- CONL/LL NW LS:01 ‘netted value UM CAFE 0686Date: __10/28/03 Rater Name: Elizabeth Lemke ——Fizabeth Lemke Pl:___Dr. Stephen Olson CAFE Reason for Treatment Phase Discontinuation Vignetios colors from the medicine. Despite efforts to help educate the patient about what might be @ symptom of her lines an what might be a real Side effect of Antipsychotic medication, she emphatically states that she will not take any more ofthis medicine. This should ou considered: 1. (1) Administrative Discontinuation 2. (I.1) Clinician decision 3. (112) Clinician decision: AUS) Patient decision 5. None of the above. tis in this situation Patient agrees to hospitalization ani This should be considered 1. (L) Administrative Discontinuation 3: IM) Clinician decision: inadequate therapeutic effect 3. 2) Clinician decision: Unacceptable side etisers UM CAFE 0688‘ale Disconlititialion (1) Clinician decision inadeaunte therapeutic effect - (l2) Clinician decision: Unacceptable side effects (113) Patient decision: RefusaliFalure te take the assigned Antipsychotic None of the above. It is not necessary to complete an end-of-phase form in this situation Administrative Discontinuation decision: det the assigned Antipsychotic plete an end-of-phase form 5. Apatient who has been dong well on his assigned medication for 6 months, reports that two weeks ago he had 2° ‘days where he felt quite Sirnmtony ter telapsing on cocaine and alcohol bey hee not had any Symptoms in the past week. This should be concidereg 1. (L) Administrative Discontinuation 2. (ll) Clinician decision: inadequate therapeutic effect 3 {Ml2) Clinician decision: Unacceptable ace effects UM CAFE 0689Agrees thal she would ike to be more active and feels impaired by the edication. Itis diffcul to assess if she is having many symptoms since She sleeps so much of the day. This should be conside co 1-(L) Administrative Discontinuation Sold) Citiian decision: inadequate therapeutic eftect cision Una csp talib Side ese Sion: RefusalFailure to take the assigned Antipsychotic . None of the above. itis not necessary to complete an end-of-phase form in this situation & A CAFE study patients hit by a car while riding his bike and is killed. This should be considered: OSD Aarne Di 2. (Il) Clinician decision, 3. {l12) Clinician decision: Unacceptable side effects 4. (113) Patient decision: Refuselailure to lake the assigned antipsychotic, Re None of the above. itis not necessary to complete an end-of-phase form in this situation Te ti 390, = UM CAFE 08: zr8. After 3 months on the ‘medication, the patient imposters resultin, considered! ‘maximum dose of assigned Antipsychotic arn ues to have delusions that his parents are in continued family conflict. ‘This should bo fepeuticleicet fects te to take the assigned Antipsychotic ©. Itis not necessary to complete an end-of-phase form (if this isn't it's #2. in this situation —it just doesn't sound like this, completely disrupts his life) UM CAFE 0691 5