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Guidance for NIH, FDA, Investigational Drug Studies and Clinical Trials

Tools for Determining if a Study Requires Registration in CT.gov

Instructions for Completing the Protection of Human Subjects Assurance Identification Form (OMB 0990-0263)

Form OMB 0990-0263

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

Creating a Regulatory Binder

Comparison of Clinical Trial Phases

Dispensing Investigational Drugs or Drugs Used In Research

Device Accountability Policy

Device Accountability Log