Good Clinical Practice (GCP)

Standard

Anyone involved in the conduct, management /leadership of clinical trials involving human subjects follows or knows about Good Clinical Practice, it is the guiding light that Biotech companies, Pharmaceutical companies, Clinical Research Organizations, government organizations involved in human clinical trials, Hospitals/investigators are required to follow if they conduct human clinical trials. For those of you not familiar with GCP, it is the recognized standard that helps to assure that the rights, safety and well-being of human subjects participating in a clinical trial are protected. Furthermore, GCP helps to protect the ethical standards and scientific quality that the sponsor and investigator should adhere to. The responsibility of assuring that GCP is adhered to usually lies with the sponsor company/agency/individuals who are held accountable to monitor the ethical standards and scientific quality initiated and maintained by the investigational staff.
Monitoring GCP is a critical task not to mention a challenging task; serious breaches have resulted in being black listed, fine and even jail time. Also, serious violations can result in the data not being used thus, perhaps a costly delay in meeting the objectives of the clinical trial. It is the responsibility of the sponsor to implement corrective actions to address non-compliance. Corrective actions in my experience have been slow to come if at all especially if the sponsor feels it is more important to protect the professional relationship of the violator; of course, that relationship could be in jeopardy when corrective actions are implemented.
The Food and Drug Administration has a specific office called, Good Clinical Practice http://tinyurl.com/8gvl34z and the FDA Regulations Relating to Good Clinical Practice and Clinical Trials can be found here http://tinyurl.com/kzp5gyj Both of these links are worth reviewing especially if you are not familiar with GCP.
I would be remiss if I did not mention the Informed Consent Form (ICF) and the importance of obtaining it before any clinical trial procedures are performed. Clearly, this is a critically important document and often times it is identified as a top compliance issue with regard to how and when the ICF was administered. See regulation 21 Code of Federal Regulations (CFR) Part 50 312 and an information sheet for developing an ICF http://tinyurl.com/7rqd97p
I have merely skimmed the surface with regard to GCP, but I should mention that GCP is an international standard; you will see GCP ICH guideline. ICH stands for International Conference on Harmonisation. The ICH guideline was developed with a focus on the current good clinical practice of the European Union, Japan, Australia, Canada, the Nordic countries and the United States in mind. See the following link for details, http://tinyurl.com/4duczor

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2 responses »

  1. Thanks for this GCP overview. I am curious if you have worked with any vendors for online GCP training for global clinical trials. There are a ton of solutions available but I’d love to hear recommendations from your experience. Keep up the great work on this interesting clinical operations blog!

    • Hi Nadia,Thanks for your response.I find it most effective to work wit an internal training/auditing group. I have not tried any online groups. As you mentioned, there are endless solutions available so the important thing is assuring everyone is trained.

      Kathryn

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