Clinical Trial AuthorisationCTA is required from the MHRA is required for all clinical trials in the UK within the scope of the UK regulations (see below).
Clinical Trials ToolkitJoint development by the Department of Health and Medical Research Council to provide information on the The Medicines for Human Use (Clinical Trials) Regulations 2004.

Other toolkits include: Data and Tissues Tool Kit; Experimental Medicine Tool Kit.

EudraCTDatabase of clinical trials in the European Community from 2004 onwards.
EudraPharmEudraPharm a database of all medicinal products for human or veterinary use that have been authorised in the European Union (EU) and the European Economic Area (EEA) and information on clinical trials of medicinal products including products with or without a marketing authorization.
Declaration of HelsinkiEthical Principles for Medical Research Involving Human Subjects first published by the World Medical Association in 1964 and updated in subsequent years.
Good Clinical Practice (GCP)The European Union Clinical Trials Directive dictates clinical trials follow the principles of Good Clinical Practice. These are specified in the EU Commission Directive on GCP. This has been incorporated into the Medicines for Human Use (Clinical Trials) Regulations 2004.
Health Research Authority (HRA)A relatively new NHS organisation that now administers the NRES. It functions to protect and promote the interests of patients and public in health research.
Integrated Research Application System (IRAS)IRAS is a single system for applying for the permissions and approvals for health research in the UK. It is the recognised format for a number of organisations including the MHRA, NHS / HSC R&D offices, NRES / NHS / HSC Research Ethics Committees, National Information Governance Board (NIGB), Ministry of Justice, Gene Therapy Advisory Committee (GTAC), Social Care Research Ethics Committee and the Administration of Radioactive Substances Advisory Committee (ARSAC).
International Conference on Harmonisation (ICH)International Conference on Harmonisation brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan and the United States.
Medicines and Healthcare Products Regulatory Agency (MHRA)United Kingdom government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe.
NIHR Clinical Research NetworkNational Institute of Health Research Clinical Research Network.
National Research Ethics Service (NRES)Now part of the HRA.
Regulatory Support CentreHosted by the Medical Research Council (UK), it provides support for investigators undertaking clinical trials.
UK Clinical Research Collaboration

 

The UKCRC brings together many partners to foster high quality clinical research.

Leave a Reply