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- Legal Framework and Regulation
- What is Good Clinical Practice (GCP)?
- How the CTRG team can help you to comply with these regulations
Legal Framework and Regulation
The Medicines for Human Use (Clinical Trials) Regulations 2004 and its amendments 2006a, 2006b, 2008 provide a legal framework for the conduct of Clinical Trials.
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates Clinical Trials and carry out inspections for compliance with Guidelines for Good Clinical Practice (GCP) (380kb).
What is Good Clinical Practice (GCP)?
GCP is an international ethical and scientific quality standard for designing, conducting and reporting trials that involve the participation of human subjects. Compliance provides public assurance that the rights, safety and well being of trial subjects are protected, and that the Clinical Trial data are credible. GCP is consistent with the principles of the Declaration of Helsinki.
How the CTRG team can help you to comply with these regulations
The remit of CTRG is to enable you to comply with these regulations together with the NHS Research Governance Framework 2005 as appropriate without this being too onerous. CTRG can facilitate the generation of documentation and execution of study approvals by providing advice and support appropriate to the knowledge and resources available to the researcher.