Common use of Procedure for sponsors Substantial Modifications Clause in Contracts

Procedure for sponsors Substantial Modifications. 5.1. Submission of a substantial modification regarding a clinical trial approved in the CTR pilot project Substantial modifications (SM) regarding clinical trials that were approved in the CTR pilot procedure will also need to be submitted following the CTR pilot project procedure. Upon submission, the SM cover letter and any other communication should clearly state: CTR pilot project number : XXX – CTA 20XX-XXXXXX-XX – Substantial modification The submission dossier must comply with the requirements of annex II of the CTR.

Procedure for sponsors Substantial Modifications. 5.1. Submission of a substantial modification regarding a clinical trial approved in the CTR pilot project Substantial modifications (SM) regarding clinical trials that were approved in the CTR pilot procedure will also need to be submitted following the CTR pilot project procedure. Upon submission, the SM cover letter and any other communication should clearly state: CTR pilot project number : XXX – CTA 20XX-XXXXXX-XX – Substantial modification SM n°XX The submission dossier must comply with the requirements of annex II of the CTR.