Relevant background documents for protocol development
NIHR clinical Trials toolkit Use this to plan a clinical study, apply for ethics and monitor progress.
Protocol guidance and template for use in qualitative research
Pre-Ethics Peer Review
Keele University Peer Review Gudance and Application Form
University Hopsptials of North Midlands NHS Trust Peer Review Application Form
Ethics
IRAS Integrated Research Application System common gateway for ethics, R&D, MHRA, SSI an other research-related approval processes.
Keele University Research Ethics guidance
Key documents and regulations
ICH GCP E6 (R3) updated clinical trials regulations legally required for all CTIMPs and other tirals in the UK as of April 28th 2026
Simplified arrangements for consent in clinical trials October 2025
Risk adapted approach to clincal trials and risk assessmements 2022
UK Policy Framework for Health and Social Care Research (update 30 Oct 2020: use this for UK)
The Medicines for Human Use (Clinical Trials) Regulations 2004 Statutory Instrument No. 1031
ESOTA table of contry specific trials regualtions in Europe
RED: Central Resource for Navigating the Clinical Study Regulatory &
Ethical Submissions Requirements in Europe hosted by ECRIN
Research Governance
Research Governance Keele University summary (short and informative, good start)
Data Protection
Data Sharing
Guidance on data sharing, developing a repository, and data sharing agreements