Which statement describes investigator obligations under 5.6.2 a-d?

• A. To conduct the trial in compliance with GCP, applicable regulatory requirements, and the protocol
• B. To conduct the trial in compliance with only the protocol
• C. To retain trial records indefinitely
• D. To disclose trial data publicly without oversight

Answer: (C)

The key idea is that investigators must run the trial in line with Good Clinical Practice, all applicable regulatory requirements, and the protocol itself. This means following the study plan, keeping participant safety and data integrity as priorities, and ensuring all activities meet the law and GCP standards. The option that describes compliance with GCP, regulatory requirements, and the protocol best captures the full scope of responsibilities, because it encompasses following the approved plan, upholding ethical and legal standards, and protecting participant rights. Retaining trial records is indeed required, but not indefinitely; the retention period is defined by regulatory requirements and sponsor/authority expectations, so an indefinite retention statement is not accurate. Public disclosure without oversight violates confidentiality and oversight protections, which is not part of investigator obligations.