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What is FDA GCP?

What is FDA GCP?

The Office of Good Clinical Practice is the focal point within the Food and Drug Administration (FDA) for good clinical practice (GCP) and human subject protection (HSP) issues arising in human research trials regulated by FDA. Provides advice on research ethics to FDA Centers related to medical product applications.

Are GCP guidelines a legal requirement?

“Those conducting clinical trials of investigational medicinal products (CTIMPs) must comply with the high level conditions and principles of GCP, but there is no legal requirement for other types of research to do so. …

What are GCP requirements?

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.

Who has to follow GCP?

Physicians and other qualified experts (“clinical investigators”) who conduct these studies are required to comply with applicable statutes and regulations.

How do I get a GCP certificate?

Good Clinical Practice (GCP) Certification

  1. Complete a CITI GCP course online.
  2. Complete an NIH GCP course online.
  3. Attend a WUSTL-sponsored instructor-led course.

Who needs a GCP certificate?

All investigators and staff who are involved in the conduct, oversight or management of NIH funded clinical trials are required to complete training in Good Clinical Practice (GCP) and refresh this training every 3 years, consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2) .

What are Good Manufacturing Practice (GMP) guidelines?

1.0 General overview.

  • Processes and Products).
  • 3.0 References.
  • 4.0 Glossary.
  • Appendix 1: Supplementary GMP for homeopathic medicines.
  • Appendix 2: Records.
  • Appendix 3: Good documentation practices.
  • Appendix 4: Standard operating procedure.
  • What are good clinical practice guidelines?

    Good Clinical Practices (GCP) Good Clinical Practices or GCP are guidelines that cover the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of clinical studies.

    What is the purpose of GCP training?

    GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials. GCP training aims to ensure that: the rights, safety, and well-being of human subjects are protected. clinical trials are conducted in accordance with approved plans with rigor and integrity.

    What are the principles of good clinical practice?

    There are 13 key principles of Good Clinical Practice (GCP). The first seven are: Adherence to ethical principles. Risk minimization. Subject’s rights, safety, and well-being. Adequate drug information.