There is no one right way to document PI oversight. Ideally, a discussion with the study team and the sponsor should be held to identify acceptable methods for achieving this. Here are some ideas that may help you identify methods to incorporate into your practice:
- Have the PI initial/date when reviewing study specific tests/procedures, adverse events, etc.
- Summarize informal communications with the PI related to the study in an email that goes to the PI and the study team
- Keep minutes of study team meetings.