UK Profile Updated in ClinRegs

The United Kingdom (UK) profile in ClinRegs has been reviewed and updated with the following:

• Updated information on the UK’s withdrawal from the European Union and its impact on clinical research (See Scope of Assessment)
• Updated information on electronic communication with UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) (See Scope of Assessment)
• A new requirement for clinical trial application fee payments, effective December 1, 2019 (See Regulatory Fees)
• A new version of the Standard Operating Procedures for Research Ethics Committees (See Ethics Committee, Clinical Trial Lifecycle, and Informed Consent topics)
• Information on the Health Research Authority (HRA)’s pilot to test a single application submission route that incorporates both the ethics committee and MHRA Clinical Trial Authorisation application submission (See Submission Process)
• Updated information and tools for clinical trial agreements (See Trial Initiation)
• Updated information on urgent safety measures and reporting (See Safety Reporting)
• Information on the UK Local Information Pack, which was launched in June 2019, to use one consistent UK-wide package to support study setup and delivery across the UK; the package replaces the Statement of Activities (used in England and Wales) and the Site Specific Information form (used in Northern Ireland and Scotland) (See Site/Investigator Selection)
• MHRA-HRA joint statement on electronic consent for clinical research (See Documentation Requirements)
• An updated version of the Consent and Participant Information Guidance, including new requirements for research involving pregnant women and fetuses (See Informed Consent topic)