Regulatory management of a study provides oversight and support for conducting sound research. It could be argued that without all the checks and balances in place, supported by regulatory documents, even the best research is open to question.
Required regulatory documents and processes may include the following:
- IND/IDE submissions to the FDA for drug and device studies - download presentation
- Clinical Trials.gov registration for investigator initiated studies.
- Institutional Review of all studies that include human subjects – initial and continuing
Documentation of the credibility of investigators and research teams:
- CV, medical license, financial disclosure, required training
- Laboratory certifications, when applicable (CLIA, CAP)
- Protocol-specific certifications
Continued maintenance and rigorous update of these is critical to a clinical trial's success. Expired regulatory documents are and will be a concern in the event of an FDA audit. Licensure of drugs requires all sites maintain these documents.