National Research Ethics Service

Phase 1 trials and procedure flowcharts

Phase 1 trials

ABPI Guidelines for Phase 1 Clinical Trials (External link)
Expert Advisory Group and Commission on Human Medicine process: Letter to RECs Chairs Trials subject to assessment by Expert Advisory Group and Commission on Human Medicine - Guidance for Ethics Committees 14 August 2007
First in Human Studies – Points to Consider in Study Placement, Design and Conduct (External link) Supplementary guidance issued by ABPI
Incentives in Phase 1 TrialsThe National Research Ethics Advisors Panel endorsed this following guidance regarding payments and incentives in phase I studies produced by the Phase I Advisory Group.
Insurance in Phase I Trials Insurance and compensation in the event of injury in Phase I clinical trials.
Guidance developed by the Association for the British Pharmaceutical
Industry, the BioIndustry Association and the Clinical Contract Research
Association in consultation with the Department of Health and the
National Research Ethics Service.
MHRA accreditation scheme for Phase 1 trial sites (External link)
Phase 1 trials in healthy volunteers - site-specific assessment Phase 1 trials in healthy volunteers - site-specific assessment: Guidance for applicants
Strategies to Identify and Mitigate Risks in First in Human Clinical Trials (External link) Guidelines from the Committee for Medicinal Products for Human Use, European Medicines Agency