Table 2 Findings and results—categories and select examples of review observations
Category of Finding | Select Examples of Observations |
|---|---|
Administrative/oversight | -Internal monitoring/oversight activities should be documented on the study monitoring log (including self-monitoring) -Delegation log should be updated periodically and reviewed for timeliness and completion -Any errors in documentation should be crossed out with a single line and initialed |
Omission | -The name of the person obtaining consent should be included on the enrollment log -The column indicating whether a person was given copy of consent should be complete -All entries on pre-screening log should be completed so that enrollments can be reconciled on enrollment log |
Error | -Dates should follow the agreed upon convention (Month, Day, Year) -Log Page numbering should be entered and checked for accuracy -Staff on delegation log should correspond to staff study amendments to IRB/REC |
Clarification needed | -The study staff end date should not be a date in the future but should be completed in real time -The types of training listed on the training log should be clarified |
AEs and deviations | -Enrollment should have ceased while study approval/funding lapsed |