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Get answers to your most important clinical trial compliance questions directly from the regulatory source. Learn from the FDA’s Good Clinical Practice Program (GCPP) how to conduct safe, effective and compliant trials that can win approval of your new drug or device. The newest edition of GCP Questions, FDA Answers is here.
This all-new edition collates more than 100 questions and answers that get right to the heart of your role as a clinical trial professional. Our 2023 edition addresses many of the challenges you may face in your clinical research, including:
- Using virtual monitoring to supplement on-site visits
- Reconsent requirement in case of a change in principal investigator
- When an investigator needs to complete and sign a new Form 1572
- Listing local laboratories on the Form 1572
- Using diagnostic centers for standard-of-care procedures
- Reporting a serious breach of GCP or protocol during the trial
- Monitoring payments to subjects
- Clinical trial translation requirements
- Storage of investigational medications
- Maintaining old documents in the investigator site file
- Maintaining documentation after a site permanently shuts down
In addition to the extensive Q&A collection, the 2023 edition provides the complete text of essential documents most often recommended by the FDA in its answers, such as:
- 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
Gain peace of mind in your next clinical trial with answers to your most pressing compliance questions, and answers to those you might not have even thought of yet, in GCP Questions, FDA Answers.
Who Will Benefit
- Researchers/investigators
- Clinical trial research directors
- Clinical trial project managers
- CRAs
- CRCs
- Consultants
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ISBN-13:
978-1-60430-216-5
Publication date:
August 2023
Page count:
794
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