GCP Questions, FDA Answers, 2022 Edition
Clinical trial compliance — and success — would be easy if the FDA directly answered your most challenging questions about good clinical practice (GCP), right?
That’s exactly what you get from the newest volume of GCP Questions, FDA Answers.
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 you to conduct safe, effective, compliant trials that can win FDA approval of your new drug or device.
Sure, you could comb through all the questions and answers the program posts yourself. But with GCPP receiving 2,400 inquiries each year, that’s impractical, to say the least.
We’ve done the hard work for you, pinpointing the questions and answers that matter to you: the most difficult — and important — topics in clinical research.
And GCP Questions, FDA Answers, 2022 Edition is comprised of entirely new content. There is no overlap with previous editions, so you’ll get the FDA’s latest advice on:
- Reporting serious adverse events
- Dealing with informed consent of non-English-speaking individuals
- Requirements for electronic consent
- Sharing 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 at your fingertips, including:
- ICH E6(R2) — Good Clinical Practice
- A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers
- Investigator Responsibilities — Protecting the Rights, Safety and Welfare of Study Subjects
- Frequently Asked Questions — Statement of Investigator (Form FDA 1572)
- Electronic Source Data in Clinical Investigations
- Safety Reporting Requirements for INDs and BA/BE (Bioavailability/Bioequivalence) Studies
- Financial Disclosure by Clinical Investigators
Limited Time Bonus: Buy the 2022 edition and get the 2021 and 2019 editions of GCP Questions free. With all three volumes, you’ll have answers to more than 350 of your most pressing questions.
Focus on running compliant trials, not on searching for how best to do it. Let GCP Questions, FDA Answers guide you.
Who Will Benefit
- Manufacturers’ R&D departments
- Hospitals’/medical centers’ clinical trial heads
- Laboratory managers
- Legal counsel
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