Toni Hegyi, Manager, Quality Assurance at IMARC Research, Inc.

No matter where you land on the clinical research spectrum, chances are you have encountered some challenges with interpreting and/or implementing Good Clinical Practice (GCP) guidelines. With so many trial designs and research settings, it can be difficult to know how to appropriately apply GCP and even more difficult at times to get answers. To help with your search, the FDA has created a page that provides copies of e-mail messages (the original inquiry and associated reply(ies)) that have been submitted by the public to the Good Clinical Practice Program’s gcp.questions@fda.hhs.gov e-mail account.  Inquiries range from 2013 to 2018 and are categorized by the following inquiry subjects:

• Adverse events
• Computers
• Device study
• FDA forms 1571 and 1572
• Financial disclosure
• Foreign studies
• Good clinical practice
• Health Insurance Portability and Accountability Act
• Human subject protection
• Informed consent
• Inspection
• Institutional review board
• Recordkeeping and record retention
• Special populations
• Training and qualifications

Often times, we can find resources for most questions that arise. However, it can be overwhelming when we run into hundreds of documents online to scour for an answer, or when we find conflicting advice from peers. As a helpful resource to have in your arsenal, the FDA e-mail bank can provide answers with clear explanations, helpful referrals, and point directly to specific resources. There are over 1,000 FDA responses to the most common, as well as the unusual and even difficult questions, around the U.S and international GCP standards available for review. This is a website to bookmark as a favorite; it can help save time, find accurate information, and allow you to move that much more quickly towards assuring safety and compliance for your clinical research.

Comprised of 13 Principles, GCP is an international quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies. The goals of GCP guidelines include protecting the rights, safety and welfare of subjects in a clinical trial and assuring that data generated from the research is reliable and accurate.

13 GCP Principles

Ethics:

1. Ethical conduct of clinical trials

2. Benefits justify risk

3. Rights, safety and well-being of subjects prevail

Protocol and science:

4. Nonclinical and clinical information supports the trial

5. Compliance with a scientifically sound, detailed protocol

Responsibilities:

6. IRB/IEC approval prior to initiation

7. Medical care/decisions by qualified physician

8. Each individual is qualified (education, training, experience) to perform his/her tasks

Informed consent:

9. Freely given from every subject prior to participation

Data quality and integrity:

10. Accurate reporting, interpretation and verification

11. Protected confidentiality of records

Investigational products:

12. Conform to good manufacturing processes (GMP’s) and user per protocol

Quality control/quality assurance:

13. Systems with procedures to ensure quality of every aspect of the trial.

For more information on GCP, please take time to review see IMARC’s whitepaper on the fundamentals of GCP.