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- CWoW IRAS Task box
- Infographic
- IRAS Development Questions and Answers
- Initial Review Process and Timelines
- Document management for combined review applications
- Delivering benefits of combined review
- Human Medicines Regulations (EAMS)
- Decentralised trial methods position statement
- Clinical trials regulations reform
- Guidance on changes to the clinical trials regulations
- Definitions and terminology
- New definitions
- Updates to existing definitions
- Update to ‘amendment’ terminology
- Pharmacovigilance
- The approvals process for clinical trials
- The approvals process for applications
- How clinical trials of investigational medicinal product applications will be processed from 28 April 2026 - long description
- The approvals process for modifications (amendments)
- The approval process and timeframes for substantial modification requests - long description