United Kingdom

United Kingdom

International Standard Registered Clinical/soCial sTudy Number (ISRCTN)

Verified on September 8, 2021

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


References


  1. 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.
  2. 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.
  3. 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.