17th Apr 2015, 02:17 PM
Distribution of IB updates to Investigators
What is the Inspectorate’s opinion on distributing updated IBs to Investigators – should they be approved by the Competent Authority (CA) and/or Ethics Committee (EC) (according to standard amendment requirements) prior to being sent to the Investigator or afterwards? ICH GCP 5.6.2 states “Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator's Brochure, and should provide sufficient time for the investigator/institution to review the protocol and the information provided” – it is generally accepted that this initial provision of the protocol and IB normally happens in parallel with CA/EC submissions. However, once the IB has become an “approved” CA/EC document, for any future updates (that are not considered urgent safety measures) should the IB be sent to the Investigator before or after CA/EC approval/notification?