c





 
 


    


 

CDM work starts once Protocol gets finalized..........CDM starts designing Case Report Form as
per protocol............so team members will be CDM, Clinical. Stats and Medical Writing
team..........once CRF gets finalized database design and data management plan documents are
generated parallel...DMP will be designed by Team lead with the help of other DM
members..........Database design team design the database.......once database design goes
through the QC process the database is set ready for data entry..............DM lead will generate
the edit check document.........this document is the key document for the study as on this basis
only the data is cleaned.........edit check document and other DMP documents need to be
approved by sponsors.........once this get approved the DBP programmers all these
checks..........once you receive the data on CRF, first pass and second pass entry is
performed........after this the batch validation is run on the data......because of batch validation
all the discrepant data is flagged by the system..........all this discrepant data is flagged in the
form of queries........the responsible team member reviews all these queries..........and
accordingly they raise the queries to the site appropriately...........the queries are raised in the
form of std text which is called as DCF and sent to the sites for resolution......sites resolves the
DCFs and send them back to DM..........DM reviews the resolution and update or close the
queries depending on the resolutions............this process goes on till there will be no queries on
entered data.....the Medical History, Adverse Events, Concomitant Medications, Surgical History
are coded using Medical Dictionaries (MEDdra, WHODD).........if external data is going to be
loaded in database then DBP designs the database to incorporate data.........the loaded data is
reconciled with the database to match the records...........if SAE reconciliation is going to be take
place then all SAEs captured in database are reconciled with the SAEs recorded at
Pharmacovigilance database...........once all the queries are resolved and all the terms are
coded, the database is declared ready for QC.........100% QC is done for critical
parameters...........QC for non-critical parameters % can be decided or as approved by
sponsor..............meanwhile Biostats dept also reviews the data.....they flag the issues which
are solved by DM.............once all these steps are cleared the database is declared as Final and
transferred to the sponsor..........

http://clinicalresearchforum.com/some-nice-videos-links-and-articles-on-clinical-research/all-
checklists-you-need-for-a-clinical-trial/
http:///@
-management/study-protocols-and-edit-checks/msg17636/#msg17636

http:///@
- 
/edit-checks/msg16452/#msg16452

http:///@
-management/sample-ecs-document/msg23343/#msg23343

You can refer following posts and let us know whether it answer your questions or not.

http:///@
-management/study-protocols-and-edit-checks/msg17636/#msg17636

http:///@
- 
/edit-checks/msg16452/#msg16452

http:///@
-management/validation-of-programmed-edit-checks/msg13948/#msg13948

http:///@
-management/sample-ecs-document/msg23343/#msg23343

http:///@
-management/can-anyone-pleae-tell-me-the-clinical-@
-management-process/

http:///@
-management/discrepancy-management/msg25309/#msg25309

http:///@
-management/validation-and-discripency-management/msg11665/#msg11665

http:///@
-management/user-acceptance-testing/msg13901/#msg13901

http:///@
-management/user-acceptance-testing/msg13853/#msg13853

http:///@
-management/user-acceptance-test/msg19290/#msg19290