CDER Assessment of FDA Regulatory Requirements - Sponsor and Clinical Investigator Compliance with GCP

How does CDER assess FDA regulatory requirements pertaining to sponsor and clinical investigator compliance with GCP?

Sponsor Responsibilities (21 CFR 312.50-312.58) - General and Specific Responsibilities of Sponsors include:

• Select qualified investigators
• Provide investigators with the information they need to conduct an investigation properly
• Ensure that the investigation is conducted in accordance with the protocol
• Maintain an effective IND for the investigators
• Maintain an effective IB for the investigators
• Maintain an effective communication with the investigators
• Ensure that FDA and participating investigators are promptly informed of significant new adverse events or risks with the clinical trial drug
• Ensure that FDA and participating investigators are promptly informed of significant changes to the protocol
• Ensure that FDA and participating investigators are promptly informed of significant new data, preclinical, clinical, same chemical class or otherwise
• Ensure that sponsor and investigators protect subject rights on study.
• More to come...