Each department conducting a clinical trial must keep a binder(s) containing every piece of documentation pertaining to the trial.
- All written Correspondence with sponsor, including e-mails
- Copies of all the regulatory documents submitted
- Approved Informed Consents
- Notes to file
- Screening/enrollment Log
- Monitor Sign-in
- Delegation of Authority
Regulatory binders, for non industry sponsored trials, will be provided to the research teams upon study activation.