Monday, April 12, 2010

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...

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