Recent changes
April 2026 - The NIHR Clinical Trials Toolkit updated to reflect the amended Clinical Trials Regulations, which took effect in the UK on 28 April 2026. Content and terminology has been updated across the CT Toolkit site, however the interactive routemap is still in the process of being updated accordingly.
October 2024 - Further links to guidance added to the Informed Consent station.
September 2024 - The Clinical Trials Toolkit pages including the Routemap has now been refreshed to include updated links.
June 2023 - Content updates to the Informed Consent and Dissemination of Results stations.
January 2023 - Content updates across the CT Toolkit to reflect changes.
May 2022 - Further reading updated within the Informed Consent station.
November 2021 - Content update within the Informed Consent station.
February 2021 - Content updates across the CT Toolkit to reflect changes due to Brexit.
May 2020 - Content updates to include updated links and revised workstream documents.
November 2019 - Content updates have been made to the Ethics Submission and R&D Submission stations.
June 2019 - Content updates including Patient and Public Involvement within the Feasibility and Investigator Selection station and Ethics Submission station. Addition of AxMP to Glossary.
February 2019 - The NIHR has a new visual identity to better reflect the breadth of its work. To find out more, please visit the NIHR website.
November 2018 - Content updates regarding Pharmacy Assurance within the Trial Supplies station, a pilot to test a combined MHRA-REC approval process in the CTA Submission station, and GDPR within the Informed Consent station.
October 2018 - Content updates regarding HRA Approval in Wales within the R&D Submission station and Ethics Submission station.
April 2018 - Content updates regarding MRC HTMR resources within the Trial Planning and Design station, Trial Management and Monitoring station, Feasibility and Investigator Selection station, and Informed Consent station.
March 2018 - Updated Trial Supplies Guide (PDF) within the Trial Supplies station.
February 2018 - Content updates including new HRA website links, EMA guidance on GCP compliance in Trial Documentation station and Final Trial Management Documentation station, UK Policy Framework inclusion in R&D Consultation station, and European Commission Guidance on CT results for laypersons in Clinical Trial Summary Report station and Dissemination of Results station.
September 2017 - Content updates including revised Monitoring Principles in the Trial Management and Monitoring station and HRA Approval within the R&D Submission station.
January 2017 - Content updates including risk-adapted approaches within the Trial Management and Monitoring station and MHRA FAQs within the Trial Master File station.
August 2016 - Content updates regarding HRA Approval within the R&D Submission station and End of Trial Declaration station.