The investigator should ensure that the investigational product(s) are used only in accordance with what?

• A. The investigational product(s) should be used only in accordance with the approved protocol.
• B. May be used for other research even if not approved.
• C. Can be used after expiration.
• D. May be used at investigator's discretion.

Answer: (A)

The key idea is that the investigational product must be used exactly as described in the approved protocol. The protocol lays out who can receive the product, what dose and route are used, how often it’s given, under what conditions, and how safety and efficacy are monitored. Following this plan protects participant safety and ensures the data are reliable and compliant with regulatory requirements and ICH-GCP.

Using the product for any purpose outside the protocol would be a protocol deviation (or require an approved amendment and ethics approval) and could put participants at risk or compromise study results. It would also be inappropriate to use the product after expiration or at the investigator’s discretion, both of which violate the protocol and regulatory standards.