Tools for Determining if a Study Requires Registration in CT.gov
Federal Form OMB 0990-0263 (formerly Form 310) is the Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption Form. It is required for Human Subjects Research activities that are conducted or supported by the Departments and Agencies adopting the Common Rule.
FDA Investigator Responsibilities
Guidance for the Investigator as a Sponsor
Guidance on Special Considerations and Reporting Requirements for FDA-NIH-DHHS Regulated Items
Comparison of Clinical Trial Phases