Good Clinical Practice (GCP)
A Good Clinical Practice (GCP) is a Clinical Best-Practice that is an International Quality Standard for clinical trials involving human subjects.
- Context:
- It enforces internationally approved regulations and medical guidelines on ethical aspects of clinical research.
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- Example(s):
- Counter-Example(s):
- See: Clinical Research, Harmonisation of Technical Requirements for Human Use (ICH), Ethical Clinical Research, Quality Assurance.
References
2021a
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Good_clinical_practice Retrieved:2021-11-19.
- QUOTE: 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 on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
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 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.
- QUOTE: 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 on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
2021b
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-20.
- QUOTE: Good clinical practice
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. (ICH E6) ...
- QUOTE: Good clinical practice
2021c
- (NIA, 2021) ⇒ NIA Glossary of Clinical Research Terms, Retrieved:2021-11-20.
- QUOTE: Good Clinical Practice – A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial participants are protected.
2021d
- (NIHR, 2021) ⇒ https://www.nihr.ac.uk/health-and-care-professionals/learning-and-support/good-clinical-practice.htm Retrieved:2021-11-20.
- QUOTE: Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted.
It is important that everyone involved in research is trained or appropriately experienced to perform the specific tasks they are being asked to undertake. GCP training is a requirement set out in the UK Policy Framework for Health and Social Care Research developed by the Health Research Authority for researchers conducting clinical trials of investigational medicinal products (CTIMPs).
- QUOTE: Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted.
2018
- (FDA/CDER/CBER, 2018) ⇒ U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research (2018) "E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry". In: OMB Control No. 0910-0843 Expiration Date 09/30/2020.
- QUOTE: Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
The objective of this ICH GCP guidance is to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
The guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization.
This guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.
The principles established in this guidance may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.
- QUOTE: Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
2002
- (WHO, 2002) ⇒ World Health Organization (2002). "Handbook For Good Clinical Research Practice (GCP). Guidance For Implementation".
- QUOTE: Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects. Compliance with GCP provides public assurance that the rights, safety, and well-being of research subjects are protected and respected, consistent with the principles enunciated in the Declaration of Helsinki and other internationally recognized ethical guidelines, and ensures the integrity of clinical research data. The conduct of clinical research is complex and this complexity is compounded by the need to involve a number of different individuals with a variety of expertise, all of who must perform their tasks skillfully and efficiently.
The responsibility for GCP is shared by all of the parties involved, including sponsors, investigators and site staff, contract research organizations (CROs), ethics committees, regulatory authorities and research subjects.
- QUOTE: Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects. Compliance with GCP provides public assurance that the rights, safety, and well-being of research subjects are protected and respected, consistent with the principles enunciated in the Declaration of Helsinki and other internationally recognized ethical guidelines, and ensures the integrity of clinical research data. The conduct of clinical research is complex and this complexity is compounded by the need to involve a number of different individuals with a variety of expertise, all of who must perform their tasks skillfully and efficiently.