Clinical Trial Agreement (CTA) is the appropriate term used to describe a document used to agree the contractual terms associated with the specific trial-related tasks and responsibilities. The CTA will be drafted based on the appropriate template for each site/ county. The Sponsor Legal Office or its delegate shall seek approval of the draft agreement (or specified clauses) from the site as necessary to ensure consistency with the trial protocol and associated trial documents. The Sponsor Legal Office or its delegate will send shall issue the draft CTA to the other party for review. Any negotiation of the CTA will be led by the Sponsor Legal Office or its delegate, which shall seek advice and/or approval of any changes to the CTA from the site, as required.(NON MOLTO CHIARO) The CTA shall receive final approval following signature by the authorised signatories of each contracting party. Hard copies, or electronic copies, of the final CTA shall be issued to the third party for signature.
Only once the contract is signed by all parties involved the centre can be activated
Clinical Trial Agreement (CTA)
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Glossary