Max Neeman Clinical Operations.

Minutes of Meeting

Meeting Start Time: 02.00PM Meeting Finish Time: 03.00PM

Meeting Type: Telecom Client:GSK

Meeting Agenda: 1. Outcome of Interim Analysis efforts 2 .Review of log forms in Inform 3.Patient compliance materials 4.Site wise review of Issues and actions

Venue: Max Neeman, (Telecom),Bangalore Date: 28 Sep 2011

Participants Invited: Sponsor Team: Ms Jessy,Ms Edith,Ms Tashan,Mr Ganesh,Mr Karthik MNI Team:Dr Nivedita, Dr.Benazir, Dr Sonia.Dr Reshma,Dr Manoj,Dr Muralidhar,Dr Vijay,Dr Rohini,Ms Shrabani

Participants Attended: Sponsor Team : Ms Jessy,Ms Edith,Ms Tashan,Mr Ganesh

MNI Team: Dr Nivedita, Dr.Benazir, Dr Sonia.Dr Reshma, ,Dr Muralidhar,Dr Vijay,Dr Rohini,Ms Shrabani

Participants Came Late-.

Dr Manoj

Discussions: Site wise reviews and discussion is as follows:

LPL100601 PI CRC Discussions

Heart centre & general Hospital Jaipur

Dr Reshma

Max Devikidevi Heart & vascular institute faket Delhi

Reshma is doing very well & very clean site till date.

Dr Sonia behal

SGR Hospital Delhi Ms Shrabani.

No issues at the site.Dr Sonia is handling the site well.

Shrabani is doing very well & now the site is under control. Ms Tashan is happy with Shrabanis work. Poona Hospial Pune Dr. Vijay/Dr Rohini Cardiac Multispeciality Hospital Vijaywada The site is doing well .No issues

Dr. Muralidhar Muralidhar is doing very well & no issues at site.

Fortis Hospital Jaipur

Dr Manoj Dr Manoj is doing well and there are no issues at site.Mr Ganesh will contact Dr Reshma if there are any issues.

Dr Nivedita Parwatkar informed the sponsor team about Dr Reshma Shenoy taking over the study as Dr Benasir will be resigning.,and Dr Reshma Shenoy will be reporting to Dr Nivedita Parwatkar..The same will be communicated to all sites .and an official mail will be sent. Ms Tashan requested all CRCs to keep data 100% clear especially the concomitant logs in the inform by counterchecking the source from the screening visit onwards as it would make it easier for the CRA,s to monitor the same. Sites with higher number of enrolled patients would start doing this from now onwards to make their respective sites free from queries and be prepared for the next Interim visit. Patient compliance materials such as Stability post news letter ,and certificate of appreciation with PI,s signature and subject name would be given to the subject. MOCA ICF and ARHI[Authorisation for release of health information should be signed by all enrolled subjects by the th completion of 30 month visit. Stability Medicine bottle magnet will be sent to the sites after the EC approvals. LTFU patients will be sent a letter on PIs letter head.

Issues Pending From Last Meeting NA

Pending Since & People Responsible NA

LIST Of MOM: Recipient: Ms Jessy,Ms Tashan ,Ms Edith,Mr Ganesh,Mr Karthik.gsk@neemanasia.com Dr.Nivedita , Dr.Benazir , Dr.Reshma , Dr.Sonia , Dr.Manoj , Dr.Muralidhar , Dr.Vijay , Dr.Rohini , Dr.Shrabani ,

Prepared by: Dr.Reshma Shenoy Clinical Research Coordinator Date: 28 Sep 2011