FDA
This section includes requirements regarding:
- Clinical Investigator (individual who conducts the study)
- FDA 1572 (drug)
- Investigator Agreement (device)
- Serious Adverse Event reports submitted to Sponsor
- Sponsor-Investigator (individual who initiates and conducts the study)
- Clinician Investigator requirements 1 or 2
- Original application and all subsequent submissions to the FDA:
- IND Application (drug)
- IDE Application (device)
- Amendments to the Application
- Adverse Event Reports
- Annual Reports
- Form 3674 (Certification of Registration to ClinicalTrials.gov)