Get the most-challenging GCP questions answered directly by the FDA so compliant trials can be conducted safely and effectively. Here’s how.
Get answers to the most challenging questions about good clinical practice (GCP) directly from the FDA.
GCP Questions, FDA Answers, 2022 Edition, the latest addition to our best-selling series features more than 70 new questions answered by the FDA’s Good Clinical Practice Program (GCPP), empowering clinical professionals to conduct safe, effective, compliant trials that can win FDA approval of the new drug or device.
Clinical trial practitioners can comb through all the questions and answers the program posts. But with GCPP receiving 2,400 inquiries each year, that’s impractical, to say the least.
The hard work is already done, pinpointing the questions and answers: the most difficult, and important, topics in clinical research.
The GCP Questions, FDA Answers, 2022 Edition is comprised of entirely new content. There is no overlap with previous editions, only the FDA’s latest advice on:
Reporting serious adverse eventsDealing with informed consent of non-English-speaking individualsRequirements for electronic consentSharing private participant information with auditors.
Using data and samples from former trial participants who are deceased sponsor vs. contract research organization (CRO) responsibility for records storage .Proof of trial staff training when protocol changes are made rescreening excluded participants after inclusion criteria are broadened Adding new sites to an investigator-initiated trial. Changing the sponsor name in ClinicalTrials.gov listings handling leftover investigational product
Plus, GCP Questions, FDA Answers includes copies of the documents and other resources most often recommended by GCPP, so they’re always available.
Limited Time Bonus: Buy the 2022 edition and get the 2021 and 2019 editions of GCP Questions free! With all three volumes, answers to more than 350 of the most pressing questions.