| FDA (if study conducted under and IND or IDE) |
Clinical Investigator (individual who conducts the study)
- FDA 1572 (drug) (The form FDA 1572/Investigator Agreement identifies the facilities where the research will take place, the reviewing/ approving IRB and sub-investigators participating in the study. The 1572 should be updated if changes are made during the course of the investigation.)
- Investigator Agreement (device)
- Serious Adverse Event reports submitted to Sponsor
Sponsor-Investigator (individual who initiates and conducts the study)
- FDA 1572 (drug) (The form FDA 1572/Investigator Agreement identifies the facilities where the research will take place, the reviewing/ approving IRB and sub-investigators participating in the study. The 1572 should be updated if changes are made during the course of the investigation.)
- Investigator Agreement (device)
- Original application and all subsequent submissions to the FDA:
- IND Application (drug)
- IDE Application (device) Amendments to the Application
- Amendments to the Application
- Adverse Event Reports
- Annual Reports
- Form 3674 (Certification of Registration to ClinicalTrials.gov)
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21 CRF 312 and 812; ICH GCP E6 Section 4.1 |