CDER/FDA - Clinical Investigator Responsibilities - Informed Consent Form 1572

Accurate execution of FDA Form 1572 is critical to FDA regulatory requirements and GCP compliance, as well, will ensure the subject is fully informed of their rights, benefits and risks of the investiagtional drug. It is the responsibility of the sponsor and the clinical investigator to ensure the informed consent accurately explains clinical trial conduct and protocol procedures.

Form 1572 includes names of investigators and sub-investigators who will be participating and/or assisting in the conduct of the clinical investigation. Proper execution of Form 1572 - the investigators make a commitment to:

• Follow current clinical protocol
• Personally conduct and/or supervise the clinical investigation
• Ensure all persons assisting in the clinical trials are informed of obligations
• Inform subjects of investigational drugs
• Ensure informed consent (21 CFR Part 50) and IRB review, approval and reporting (21 CFR Part 56) are conducted under GCP compliance and FDA regulatory requirements
• Report to pharma sponsor all adverse events (21 CFR 312.64)
• Inform all clinical site associates of changes to protocol
• Maintain adequate and accurate records and make available all records and source documents for FDA/DSI inspection, for cause or otherwise (21 CRF 312.68)
• Ensure initial and continuing review by IRB
• Report all changes to protocol and clinical research
• Report all anticipated or unanticipated problems involving risks and benefits to subjects
• Ensure no changes to the clinical protocol in general
• Ensure good clinical conduct
• Ensure that no changes are made to the clinical protocol without IRB approval except where necessary to eliminate immediate hazards and life-threatening events to subjects
• Comply with all FDA regulatory requirements in 21 CFR 312.