The investigator should comply with the protocol; what is required?

• A. The investigator may implement any changes without sponsor agreement.
• B. The sponsor may override the protocol at will.
• C. The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor and approved by IRB/IEC.
• D. Compliance with the protocol is optional.

Answer: (C)

In clinical trials, the protocol acts as the trial’s blueprint, and the investigator’s job is to carry out the study exactly as it was approved. The investigator should conduct the trial in compliance with the protocol that has been agreed to by the sponsor and approved by the IRB/IEC. This ensures participant safety and the integrity of the data. Any changes to the protocol must be reviewed and approved by both the sponsor and the IRB/IEC before they’re implemented, and deviations should be documented and addressed per the protocol and regulatory requirements. Unilateral changes or treating compliance as optional are not allowed, as they jeopardize safety and reliability.