A glance at Good Clinical Practice regulations

Good Clinical Practices are a collectively bunched global scientific, quality and ethical standard relating to the following aspects of a clinical research:

  • Design
  • Conduct
  • Documentation (recording)
  • Report making

Relevant Good Clinical Practice regulations are to be followed by the sponsors of a clinical trial, no matter how big or small the trial or the company doing it is, and no matter how many subjects are involved in the study. These Good Clinical Practice regulations are to be implemented by everyone involved in sponsoring the study, such as the investigators, the sponsors and the principal, and very importantly, the ethics committee of such studies.

Both Good Clinical Practice regulations and good practice guidelines come under the same regulatory umbrella. Good Clinical Practice regulations and guidelines are set out by the International Conference on Harmonization (ICH). The ICH prescribes the procedures that sponsors of a clinical study have to comply with for conducting clinical research.

Intentions and benefits

Good Clinical Practice regulations and guidelines are formulated with the intention of protecting the safety, rights and wellbeing of the subjects involved in the clinical research are protected and ensured. Another aim of Good Clinical Practice regulations and guidelines is to lead to the creation and accretion of clinical data, which can be used for further research and studies.

13 principles of Good Clinical Practice regulations and Good Clinical Practice guidelines

Good Clinical Practice regulations and Good Clinical Practice guidelines set out by the ICH contain 13 core principles. They include the following:

  • Adherence to ethical principles as laid out by the Helsinki Declaration
  • Good Clinical Practice regulations require that clinical trials be consistent with regulatory requirements
  • Good Clinical Practice regulations require the sponsor to make available clinical and nonclinical data from the study to support further related research
  • Another criterion of Good Clinical Practice regulations is that the trials should thoroughly assess the risks and benefits inherent in a clinical research
  • The clinical research should ensure the wellbeing of its subjects
  • Good Clinical Practice regulations require sponsors of a clinical trial to contain a clearly defined protocol that should be rooted in established scientific principles and practices
  • A clinical research program must be subject to oversight from an independent Ethics Committee
  • The responsibility of taking medical care of the subjects has to be vested in a qualified medical practitioner or dentist
  • Good Clinical Practice regulations requires the sponsor to obtain informed consent from each of the subjects
  • Good Clinical Practice regulations requires adherence to set documentation practices
  • There should be thorough confidentiality of information relating to the subject
  • The adherence to applicable Good Manufacturing Practices (GMP) by the sponsors when it comes to the manufacture, storing and handling of investigational products is another requirement of Good Clinical Practice regulations
  • Finally, the principles of Good Clinical Practice regulations require the implementation of systems with procedures that bring about complete quality at every stage of the clinical trial
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