Common issues: Validation
Updated 6 November 2023
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This publication is available at https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications/common-issues-validation
Since the initial publication of this guidance in 2017, we have seen validation failures fall from approximately 15% to 6%. The most frequent causes of an application being considered invalid are listed in this section.
Your submission will be validated on receipt and an acknowledgement letter will be sent to the person submitting the application. This is the person named in section C of the CTA application form (Annex 1) and Declaration of the End of Trial form (Annex 3) or section D of the Substantial Amendment Notification Form (Annex 2). If the application is valid then the assessment period will begin. This starts from the date of receipt of the valid application. If the application is not valid, then the person making the application will be told of the deficiencies. A new application containing all the necessary components will need to be provided.
1. Failure to supply an XML file of the completed CTA application form
The XML file of the completed CTA application form is required to enable us to create an electronic record of your trial in our database. If this is not present in your submission, or is invalid, we cannot validate the application.
2. Failure to submit under the appropriate submission category
Applicants must check the submission guidance to ensure submission under the relevant submission category. Failure to do so will result in invalidation and delays to your submission.
3. Failure to provide PDF documents that have undergone optical character recognition (OCR)
PDF documents of the protocol, investigator’s brochure (IB), Investigational Medicinal Product Dossier (IMPD) and Summary of Product Characteristics (SmPC) (where appropriate) should be created directly from Word or undergo Adobe Acrobat optical character recognition (OCR) at the time of creation. PDF document scanned images should not be provided as it is not possible to search for key words or cut-and-paste data in this format.
4. Absence of mandatory documentation
All submissions are to include a cover letter and the following signed forms as appropriate: CTA application form (Annex 1), Substantial Amendment form (Annex 2) and an updated CTA application form (Annex 1) if it is being amended, a Declaration of End of Trial Notification form (Annex 3)