Information about applying to conduct a clinical trial.
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1 April 2011: The Clinical Trials Notification Scheme has been launched. Please refer to the Notification Scheme web pages for details of the types of applications that can be submitted under the Notification Scheme and the requirements for submission. |
General information
General information about conducting a clinical trial in the UK.
Additional information
Additional information about conducting a clinical trial.
Withdrawal of a Clinical Trial Authorisation
Applicants may withdraw their request for a Clinical Trial Authorisation (CTA) at any point prior to the MHRA having reached a decision on authorisation.
EudraCT Version 8
EudraCT V8 is now available, please refer to the guidance provided on the EudraCT website (external link) for details of the new features.
Please note; IRAS is due to be upgraded within the next few weeks, please refer to the IRAS website (external link) for guidance. MHRA will accept version 7 application forms during this time.
What to send
Details of what you need to send us when making a clinical trial application.
Applications requiring expert advice
Information about applications that require expert advice.
Changes to the submitted documentation during evaluation
Following the submission of a request for a Clinical Trial Authorisation (CTA), the applicant may submit updated or additional supporting documentation prior to the MHRA assessors commencing their assessment of the application.
Go to changes to the submitted documentation during evaluation page
