Substantial Modifications: CTR
Substantial Modifications under CTR must be submitted via the CTIS System:
New Clinical Trials Information System - NREC (nrecoffice.ie).
- Part II National Requirements for Ireland can be found here
- You can find more information about Fees here
- For more information on the application and review process , please visit the NREC-CT FAQ and Resources page
Please note NREC have an optional template Cover Letter for Part II Substantial Modifications for Ireland available for download here:
To Note
- A substantial modification (SM) cannot be submitted while any other application for that clinical trial is still ongoing (be it an initial application, a request to add an MSC, or another SM).
- For multinational applications, all MSC must have entered their decision on the previous application, before a new application on Part I can be submitted. The only exception is Part II only SMs for different MSC, which can be submitted in parallel. Part II SM assessments can run in parallel in different MSc.
- For each substantial modification (SM), along with the updated or new documents, two documents should be submitted in CTIS to summarize the changes: a cover letter and a modification description. Templates are available on CTCG website.
- The cover letter provides any relevant background information on the application, and a concise summary of the changes. The modification description contains a complete list of all new or modified documents and data that were submitted with the SM.