Which statement is included to confirm compliance with protocol and regulatory requirements?

• A. The trial will be conducted according to the protocol only
• B. Documentation will be kept at sponsor site only
• C. A statement that the trial will be conducted in compliance with the protocol, GCP and applicable regulatory requirements
• D. The trial will be conducted without regulatory oversight

Answer: (C)

A formal commitment to comply with both the protocol and all applicable regulatory requirements under GCP is what this statement represents. This phrase explicitly ties the study’s conduct to the approved protocol plus the overarching ethical and legal standards that govern clinical research. It signals that the investigator will adhere not only to the trial’s procedures but also to Good Clinical Practice guidelines and any regulatory rules, such as safety reporting, informed consent, and record-keeping. This comprehensive assurance is what regulators and ethics committees look for to confirm that the study will be conducted in a compliant and accountable manner.

Choosing a statement that mentions only following the protocol misses the broader requirements of GCP and regulatory oversight. Claiming documentation is kept at the sponsor site alone ignores site-level responsibilities and oversight. Saying there will be no regulatory oversight directly conflicts with the mandate to follow regulatory and ethical standards. By explicitly stating compliance with the protocol, GCP, and applicable regulatory requirements, the document covers both the study’s procedures and the necessary regulatory framework.