SOCRA CCRP Practice Exam

What do FDA regulations mandate for sponsors regarding the Investigator's Brochure?

1. Provide it only at the end of the investigation

2. Provide at the beginning and keep investigators informed of new AEs

3. They do not need to provide it

4. Inform investigators about AEs only

The correct answer is: Provide at the beginning and keep investigators informed of new AEs

The FDA regulations mandate that sponsors provide the Investigator's Brochure at the beginning of an investigation and keep investigators informed of any new adverse events. This is to ensure that investigators have the most up-to-date information on the investigational product in order to make informed decisions about the safety and effectiveness of the product. Providing the brochure only at the end of the investigation (option A) would not be sufficient, as it would not allow investigators to make any necessary adjustments during the trial. Option C is incorrect, as the regulations do require sponsors to provide the Investigator's Brochure. Option D is also incorrect, as the regulations not only require informing investigators about adverse events, but also providing the full Investigator's Brochure. Therefore, option B is the correct and complete answer.