Recent changes

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.