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
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
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
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