Question

The investigators in a cooperative group decided to change the time of infusion of one of the study drugs in a protocol from 2 hours to one hour because it was found to be safe and took less nursing time. They amended the protocol and notified the participating institutions that subsequent patients enrolled on study were to receive treatment under the new guidelines. What procedures must be followed by the investigators at each institution?

Answer 1

The investigators should amend the protocol, get IRB approval, notify the institutions, and provide updated guidelines to ensure patient safety and informed consent.

Step-by-step explanation:

When the investigators decide to change the time of infusion of a study drug in a protocol, they must follow specific procedures at each institution. First, they must amend the protocol to include the new guidelines for the time of infusion. The amended protocol should be approved by the Institutional Review Board (IRB) at each institution. The investigators should then notify the participating institutions about the change and provide them with the updated protocol. Subsequent patients enrolled in the study should receive treatment according to the new guidelines.

It is important for the investigators to ensure patient safety and inform the participants about any changes in the protocol. The participants should provide informed consent for the new treatment guidelines, understanding the potential risks and benefits. The investigators should also document the changes and communicate them to the relevant regulatory authorities.