Which statement is true regarding ICH E6 Section 5.5 and FDA regulations?

Which statement is true regarding ICH E6 Section 5.5 and FDA regulations?

• A. The sponsor is responsible for trial management and data handling
• B. Only the investigator is responsible
• C. Data handling is only the responsibility of the CRO
• D. There is no requirement for trial management

Answer: (A)

The correct statement emphasizes that the sponsor holds the primary responsibility for trial management and data handling, a principle that aligns with both ICH E6 guidelines and FDA regulations. The ICH E6 guideline outlines the duties of a sponsor, which include ensuring that clinical trials are conducted according to the protocol, maintaining data integrity, and ensuring compliance with regulatory requirements. While investigators and Clinical Research Organizations (CROs) play crucial roles in the conduct of a trial and may handle specific aspects of data collection and management, the ultimate accountability for trial oversight and data accuracy rests with the sponsor. This ensures that there is a single, coherent point of responsibility for trial-related activities, which is essential for maintaining the integrity of clinical research. The other statements incorrectly attribute responsibility solely to either the investigator or the CRO or suggest that management is optional, which undermines the structured approach required in clinical trials to protect participant welfare and ensure the reliability of results.

The correct statement emphasizes that the sponsor holds the primary responsibility for trial management and data handling, a principle that aligns with both ICH E6 guidelines and FDA regulations. The ICH E6 guideline outlines the duties of a sponsor, which include ensuring that clinical trials are conducted according to the protocol, maintaining data integrity, and ensuring compliance with regulatory requirements.

While investigators and Clinical Research Organizations (CROs) play crucial roles in the conduct of a trial and may handle specific aspects of data collection and management, the ultimate accountability for trial oversight and data accuracy rests with the sponsor. This ensures that there is a single, coherent point of responsibility for trial-related activities, which is essential for maintaining the integrity of clinical research.

The other statements incorrectly attribute responsibility solely to either the investigator or the CRO or suggest that management is optional, which undermines the structured approach required in clinical trials to protect participant welfare and ensure the reliability of results.