UK Profile Updated
The United Kingdom profile in ClinRegs has been reviewed for accuracy and updated with the following information:
- Updates to the combined review processes for clinical trials (See Scope of Assessment and Clinical Trial Lifecycle topic)
- Updated information about the UK Research Ethics Service (See Ethics Committee)
- Updated standard operating procedures for UK research ethics committees (ECs) (See Ethics Committee topic and Submission Process)
- Updated information on the accreditation scheme for ECs and associated quality control and quality assurance (See Oversight of Ethics Committees)
- Updated guidance on requesting approval of trials with complex innovative designs (See Scope of Assessment and Submission Process)
- Updated safety reporting procedures (See Safety Reporting)
- Updated information on ending a clinical trial (See Progress Reporting and Risk & Quality Management)
- New and updated requirements on research involving vulnerable people (see Vulnerable Populations and Children/Minors)
Sources Added During this Update:
(Document) Involving Children in Research: MRC and ESRC Joint Guidance (GBR-4) (September 11, 2021)
Medical Research Council and Economic and Social Research Council, UK
(Form) Notification of the End of a Clinical Trial of a Medicine for Human Use to the UK Competent Authority (GBR-133) (September 29, 2021)
Medicines and Healthcare Products Regulatory Agency
(Webpage) Decommission of eSUSAR (GBR-127) (August 3, 2022)
Medicines and Healthcare Products Regulatory Agency
(Webpage) Ending Your Project (GBR-128) (Last Updated May 10, 2022)
Health Research Authority
(Webpage) HRA and Devolved Administrations Accreditation Scheme Report (GBR-124) (Last Updated December 6, 2022)
Health Research Authority
(Webpage) ICSR Submissions Login Page (GBR-126) (Current as of January 13, 2023)
Medicines and Healthcare Products Regulatory Agency
(Webpage) IRAS for Combined Review Login Page (GBR-125) (Current as of January 13, 2023)
Health Research Authority
(Webpage) Quality Assurance (GBR-123) (Last Updated August 31, 2022)
Health Research Authority
(Webpage) Research Ethics Service and Research Ethics Committees (GBR-51) (Current as of January 13, 2023)
Health Research Authority
(Webpage) Research Involving Children (GBR-130) (Last Updated September 6, 2021)
Health Research Authority
(Webpage) Research with Potentially Vulnerable People (GBR-131) (Last Updated June 16, 2022)
UK Research and Innovation
(Webpage) Search RECs (GBR-112) (Current as of January 13, 2023)
Health Research Authority
(Webpage) What is Valid Consent? (GBR-129) (October 14, 2022)
Information Commissioner’s Office
Sources Revised During this Update:
(Guidance) Clinical Trials for Medicines: Apply for Authorisation in the UK (G-CTApp) (Last Updated July 18, 2022)
Medicines and Healthcare Products Regulatory Agency
(Guidance) Clinical Trials for Medicines: Manage Your Authorisation, Report Safety Issues (G-CTAuth-GBR) (Last Updated November 8, 2022)
Medicines and Healthcare Products Regulatory Agency
(Guidance) GDPR Guidance for Researchers and Study Coordinators (G-GDPR) (Current as of January 13, 2023)
Health Research Authority
(Guidance) Guidance on the Licensing of Biosimilar Products (G-Biosimilars) (Last Updated November 7, 2022)
Medicines and Healthcare Products Regulatory Agency
(Guidance) Step-by-step Guide to Using IRAS for Combined Review (G-IRASCombRev) (Last Updated January 5, 2023)
Health Research Authority
(International Agreement) Agreement on the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (WithdrlAgrmt) (Current consolidated version: February 22, 2022)
European Union, European Atomic Energy Community, and the United Kingdom of Great Britain and Northern Ireland
(Legislation) Data Protection Act 2018 (UK-DPAct) (Current through January 12, 2023)
UK Parliament
(Legislation) Human Tissue Act 2004 (UK-HTA) (Current through January 13, 2023)
UK Parliament
(Document) RES SOPs (Version 7.6) Summary of Changes (GBR-8) (September 2022)
UK Health Departments’ Research Ethics Service, Health Research Authority
(Document) Standard Operating Procedures for Research Ethics Committees (GBR-9) (Version 7.6) (Effective September 26, 2022)
UK Health Departments’ Research Ethics Service, Health Research Authority
(Webpage) Applying to a Research Ethics Committee (GBR-68) (Last Updated October 27, 2022)
Health Research Authority
(Webpage) Combined Review (GBR-72) (Last Updated December 9, 2022)
Health Research Authority
(Webpage) EudraCT – European Union Drug Regulating Authorities Clinical Trials Database (GBR-87) (Last Updated December 15, 2022)
European Medicines Agency
(Webpage) Fast-track Research Ethics Review (GBR-116) (Last Updated December 20, 2022)
Health Research Authority
(Webpage) Good Clinical Practice for Clinical Trials (GBR-92) (Last Updated January 11, 2023)
Medicines and Healthcare Products Regulatory Agency
(Webpage) Integrated Research Application System (IRAS) Login Page (GBR-78) (Version 6.3.3) (Last Updated November 14, 2022)
Health Research Authority
(Webpage) IRAS Development Questions and Answers (GBR-122) (Last Updated May 12, 2022)
Health Research Authority
(Webpage) IRAS - Templates for Supporting Documents (GBR-107) (Last Updated December 20, 2022)
Health Research Authority, Department of Health and Social Care
(Webpage) Online Booking Service (GBR-95) (Last Updated February 25, 2022)
Health Research Authority
(Webpage) Progress Reports (GBR-65) (Last Updated July 28, 2022)
Health Research Authority
(Webpage) Research Ethics Service (GBR-62) (Last Updated August 31, 2022)
Health Research Authority
(Webpage) Research Registration and Research Project Identifiers (GBR-102) (Last Updated May 25, 2022)
Health Research Authority, Department of Health and Social Care
(Webpage) Research Transparency (GBR-55) (Last Updated December 19, 2022)
Health Research Authority
(Webpage) Safety Reporting (GBR-99) (Last Updated October 7, 2022)
Health Research Authority
(Webpage) UK Policy Framework for Health and Social Care Research (GBR-101) (Last Updated November 4, 2022)
Health Research Authority (England), the Department of Health and Social Care (Northern Ireland), the Scottish Government Health and Social Care Directorates, and the Department for Health and Social Services (Wales)