PET trials: Additional information

Do I need a CTA?
The following are fictitious examples of PET ligand trials to help you determine when a CTA is required

PET ligand trials (21Kb)

What is in my CTA?
Key documents to be sent with your CTA submission:

• covering letter
• proof of payment
• receipt of confirmation of EudraCT number
• application form (and EudraCT XML file)
• clinical trial protocol with all amendments to date
• a summary of relevant data that support the use of the IMP in the clinical trial. This can be provided as an investigator’s brochure or may be incorporated into the protocol.
• full or simplified IMPD providing details on the manufacture of the active and placebo (if relevant) product
• examples of the label in the national language
• copy of the manufacturing authorisation(s) for the site(s) performing manufacture and/or assembly in order to modify the product
• TSE certificates (when applicable)

Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of trial (CT-1) (external link)

Mock IMPDs for marketed products that have been modified for use in the trial:

Mock IMPD for PET – non clinical (110Kb)

Mock IMPD for PET - pharmaceutical (174Kb)

Guidance on the dossier requirements for non-IMPs can be found in the following guidance document:

Guidance on Investigational Medicinal Products (IMPS) and 'Non Investigational Medicinal Products' (NIMPS) (Rev. 1,March 2011) (external link)