A Phase I drug trial has been completed and preparations are being made to proceed...

The sponsor is responsible for updating the Investigator's Brochure (IB) with new information obtained from the completed Phase I trial. The IB must reflect the most current data on the drug’s safety, efficacy, and dosing to support Phase II planning and execution.

According to GCP guidelines, the sponsor must ensure that the IB is updated regularly with relevant findings from ongoing and completed trials.

"The sponsor is responsible for ensuring that the Investigator’s Brochure is updated with the latest safety and efficacy data before advancing to the next phase of the trial."

Objectives:

Keep the IB current and accurate.

Inform investigators of the latest safety and efficacy data.