Mahesh Koppula

trainee pharmacist

Registered pharmacist

During the course, very well understood the protocol and content of the protocol like visit structure, procedures, therapeutic area and randomization especially which is applicable to develop database.

•Has knowledge on CRF (Case report form) entry & Query resolution.

•Successfully learned industry based training to design paper CRF from the protocol.

•Knowledge of 21 CFR Part 11, Good Clinical Data Management Practice (GCDMP).

•Has knowledge on Edit checks, open source tools - Open Clinica & open CDMS

•Has knowledge Data validation, generating DCFs & DCF tracking etc.

•Review and Resolve discrepancies identified by the system or through manual checks as per guidelines.

•Review Case Report Form, track missing CRFs for the study.