CTA Submission
Trial Approvals Phase
CTA Submission follows the IRAS station and precedes the Ethics Submission station. The process occurs in parallel with Ethics Submission and R&D Submission. CTA Submission is a legal requirement for trials within the Clinical Trial Regulations scope. This station is part of the 'trial approvals phase' group of stations.
CTA Submission
In the UK, a Clinical Trial Approval (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) is required for a Clinical Trial of an Investigational Medicinal Product (CTIMP) and IMP/device trials.
The amended Clinical Trials Regulations require clinical trial applications to be submitted through the Combined Review process via the Integrated Research Application System (IRAS). All applications submitted on or after 28 April 2026 are assessed under the updated framework, which is referred to by the MHRA and Health Research Authority (HRA) as the ‘new rules’ process. Further information on the Combined Review process is available on the HRA website. The MHRA has published guidance on common issues identified during clinical trial applications as well as detailed information on how to submit a CTA, including the documents required as part of an application.
For IMP/Device trials, the MHRA provides specific guidance on submitting an application. For ongoing trials submitted prior to 28 April 2026, transitional arrangements apply.
Notifiable Trials
The amended Clinical Trials Regulations make provision for Notifiable Trials, which, if they meet the inclusion/exclusion criteria and other criteria (.PDF), will receive automatic MHRA approval within 14 days of validation, and should receive REC approval, or approval with conditions, within 30 days of validation.
Trials Requiring Expert Advice
The MHRA and the REC may consult a relevant committee or specialist group on an application for clinical trial approval before issuing a decision. The MHRA provides details on when expert advice may be required.
Lapse of approvals
Under the amended Clinical Trials Regulations, if a CTIMP recruits no participants within 2 years, its approval lapses. The sponsor must end the trial and notify in writing by that date; however, the sponsor may apply for extensions as described on the HRA website.
Further Reading
- HRA: Step-by-step guide to using IRAS for combined review
- MHRA Guidance: Applying for approval in the UK.
- Clinical Trial Approval: (.PDF) Flowchart showing timelines
- Ethics Submission station.
- Permission and Approvals Obtained station.