United Kingdom (UK) has a primary registry, International Standard Registered Clinical/soCial sTudy Number (ISRCTN), which has provision to report both protocol registration and results posting. It is a World Health Organization (WHO) recognized primary registry. Post-Brexit, the UK is not a part of EEA countries anymore. Hence, it does not follow EU Directive for disclosure of protocol and results.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| ISRCTN | Academic/Patient Registries/Voluntary | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 1-4);Observational |
English |
| NIHR | Additional National Registry/Database (may be mandatory) | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 1-4);Observational |
English |
| Registration and Results Requirements | |||
| Registry | Activity | Legal Requirement | Timing |
| ISRCTN | Registration |
No |
Prior to Enrollment no later than six weeks after recruitment of the first participant |
| Results |
No |
Within 12 months of Study Completion (Non-paediatric Studies); Within 6 months of Study Completion (Paediatric Studies) | |
| NIHR | Registration |
n/a |
Not applicable (NA) |
| Results |
n/a |
NA | |
Registry Updates
- June 2022: ISRCTN Registry Update - The ISRCTN Registry has recently updated its display of study records for making compliance tracking easier, and to encourage trialists to follow transparency recommendations. Registry records now display green badges to highlight prospective registration, regular updating of ongoing records and posting protocols, statistical analysis plans (SAPs), data links, and results to the record.
- April 2022: Combined Review – New Video Explains IRAS User Roles and Recent Changes - On 06 April 2022, HRA UK posted on its website, a short, animated video to explain how the different roles work in IRAS for combined review and the permissions each has in the system. The clip focuses on collaborators, covering recent changes to IRAS for combined review of a CTIMP or combined CTIMP and device … Continue reading "April 2022: Combined Review – New Video Explains IRAS User Roles and Recent Changes"
- March 2022: The Draft UK Resolution: Strengthening Clinical Trials to Improve Public Health - An article, “UK proposes global effort to strengthen clinical trial transparency” has been published on 30 March, 2022, on TranspariMED. On 30 March 2022, an original draft resolution text by the United Kingdom – ‘Strengthening Clinical Trials to Improve Public Health’ was made available online. The UK will make a proposal at the 75th World Health … Continue reading "March 2022: The Draft UK Resolution: Strengthening Clinical Trials to Improve Public Health"
References
- Clinical Trials for Medicines in the UK: https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk#registration-of-your-clinical-trial. Published December 18, 2014. Accessed May 19, 2021.
- Research Registration Deferrals Policy and Procedure: https://s3.eu-west-2.amazonaws.com/www.hra.nhs.uk/media/documents/Research_Registration_Deferrals_Policy_and_Procedure_v1.9_Final_VLRPT0R.pdf. Published December 2020. Accessed December 2020.
- Research Summary Deferrals Policy and Procedure: https://s3.eu-west-2.amazonaws.com/www.hra.nhs.uk/media/documents/Research_Summary_Deferrals_Policy_and_Procedure_v1.3_Final_2UMA7Yy.pdf. Published December 2020. Accessed December 2020.
- HRA-ISRCTN FAQs: HRA-ISRCTN Registry partnership – questions and answers – Health Research Authority. Accessed 09 Feb 2022.
- Research Registration and Research Project Identifiers: Registration of Trials Submitted Through Combined Review. Accessed 25 Mar 2022.