This document discusses common source data issues found in clinical trials in India, including lab parameters not having normal control standards noted, ECG strips capturing abnormalities but not being recorded in case report forms, pages of source documents being unsigned, trial requisition forms and verification of vitals being missing or unsigned, inadequate or inaccurate case histories, incorrect or incomplete documentation of drug disposition, failure to capture protocol deviations or delays in ethics committee notification, patient visit sources being placed in the wrong file, and unresolved findings and delays in reporting adverse events.

1. Most common source data
related issues in India
Presenter:
Dr. Ashish Singh PariharPh.D.

2. Issues
NCS not mentioned for every lab parameters which is slightly out of
range.
ECG strip with NCS but they usually missed to capture abnormality in
CRF.
Few pages left unsigned in source by PI
Few Trial requisition form missing at site.
Data recorded by ….signed but verified by ….unsigned for vitals,
physical assessment etc.
Failure to maintain adequate and accurate case histories when asked
then search for it and place in pt. file

3. Cont..
Incorrect/incomplete documentation regarding the disposition of
drugs-dates, quantity and use by subjects.
Missed to capture PD in source and delay in EC notification
Pt. visit source placed in other pt. file
Un resolved findings in source from previous monitoring visit
Delay in capture AE in source and so on…….