Good clinical practice

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Good clinical practice (GCP) is likely to follow the International Conference on Harmonisation (ICH) of GCP guidelines in many aspects. GCP will enforce tighter guidelines on ethical aspects of a clinical study. Higher standards will be required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities including computers. Quality assurance and inspections will 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. Today, the GCP are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights. Ongoing research shows that whether conducting research involving a new drug, a behavioral intervention, or an interview or survey, GCP provides investigators and their study teams with the tools to protect human subjects and collect quality data.[1][2]

GCP is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. A similar guideline for clinical trials of medical devices is the international standard ISO 14155, that is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.[3]

GCP guidelines include protection of human rights as a subject in 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 clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates.

ICH GCP overview[edit]

See also[edit]

References[edit]

  • Verma K (2013) Base of a Research: Good Clinical Practice in Clinical Trials. J Clin Trials 3: 128. doi:10.4172/2167-0870.1000128

Notes[edit]

  1. ^ Verma K (2013) Base of a Research: Good Clinical Practice in Clinical Trials. J Clin Trials 3: 128. doi:10.4172/2167-0870.1000128
  2. ^ "Base of a Research: Good Clinical Practice in Clinical Trials | Full-text OMICS Publishing Group". Omicsgroup.org. Retrieved 2013-11-23. 
  3. ^ Examples of clinical practice guidelines using 'good clinical practice' as lowest grade of recommendation

External links[edit]