Which document updates the Investigator's Brochure during the trial?

Which document updates the Investigator's Brochure during the trial?

• A. Master Randomization List
• B. Any Revision to Trial Documents
• C. Dated, Documented Approval/Favorable Opinion of IRB/IEC of Trial Related Documents
• D. Investigator's Brochure Updates

Answer: (D)

During a trial, the Investigator’s Brochure is treated as a living document that must reflect all new information that could affect safety or the trial’s risk/benefit. When new data or findings become available, they are incorporated through an Investigator’s Brochure update (an addendum) that revises the IB. This updated IB is then circulated to investigators and site staff so they have the current safety and efficacy information, and it may trigger IRB/IEC review for approval before the updated information is used in the trial. The other items don’t perform this updating function: a Master Randomization List is about allocation and not the IB, a generic revision to trial documents is too broad and does not specify updating the IB itself, and while IRB/IEC approval is required for changes to trial documents, the document that actually carries the new information is the Investigator’s Brochure Update.

During a trial, the Investigator’s Brochure is treated as a living document that must reflect all new information that could affect safety or the trial’s risk/benefit. When new data or findings become available, they are incorporated through an Investigator’s Brochure update (an addendum) that revises the IB. This updated IB is then circulated to investigators and site staff so they have the current safety and efficacy information, and it may trigger IRB/IEC review for approval before the updated information is used in the trial. The other items don’t perform this updating function: a Master Randomization List is about allocation and not the IB, a generic revision to trial documents is too broad and does not specify updating the IB itself, and while IRB/IEC approval is required for changes to trial documents, the document that actually carries the new information is the Investigator’s Brochure Update.