Good clinical practice

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Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.

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High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented.

GCP guidelines [1] include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates.

A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research.

ICH GCP overview

Criticism

GCP has been called 'a less morally authoritative document' than the Declaration of Helsinki, lacking moral principles and guidance in the following areas: [5]

In the book Bad Pharma , Ben Goldacre mentions these criticisms and notes that the GCP rules "aren't terrible... [they are] more focused on procedures, while Helsinki clearly articulates moral principles". [6]

See also

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A glossary of terms used in clinical research.

The following outline is provided as an overview of and topical guide to clinical research:

In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today takes the form of an electronic trial master file (eTMF). The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. This guidance document established the requirement across all ICH regions to establish trial master files containing essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.[2] In some jurisdictions, for example the USA, there is no specific requirement for a trial master file. However, if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.[2]

Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.

References

  1. "ICH Official web site : ICH". www.ich.org. Retrieved 2021-11-24.
  2. "Clinical trials - Directive 2001/20/EC - European Commission".
  3. Commissioner, Office of the. "Clinical Trials and Human Subject Protection". www.fda.gov. Retrieved 2018-11-01.
  4. "Good Clinical Practice Training | grants.nih.gov". grants.nih.gov. Retrieved 2020-04-03.
  5. Kimmelman, Jonathan; Weijer, Charles; Meslin, Eric M (2009). "Helsinki discords: FDA, ethics, and international drug trials". The Lancet. 373 (9657): 13–14. doi:10.1016/S0140-6736(08)61936-4. PMID   19121708.
  6. Ben Goldacre (2012). Bad Pharma. London: Fourth Estate. OL   25682902M.