Concord Hospital Concord Hospital
The Concord Research Office

REGIS Guides

The CPI/PI delegation functionality was released on Wednesday 19 October 2022.

The main functionality of this enhancement is to allow Coordinating Principal Investigators and Principal Investigators to delegate the administrative task of submitting applications and forms in REGIS.

 

This does not remove the overall responsibility of the study from the Coordinating Principal Investigator or the overall responsibility of the study at the site from the Principal Investigator.

 

All significant protocol amendments* must be submitted with a cover letter signed by the Coordinating Principal Investigator.

Please refer to the following Quick Reference Guides:

Sharing Access to an Application/Project

Approving Delegate Submitter Access Requests

 

* Significant protocol amendments include but are not limited to: changes to trial methodology, inclusion/exclusion criteria, recruitment processes, data management processes and participant consent processes.  If you are unsure, please contact the Research Office prior to submitting the amendment for confirmation.

 

Please find below, a number of useful guides to assist you with your REGIS application.

1. Responding to a Request for Further Information

2. How to Submit a General Amendment

3. How to Submit an Amendment to add a New Site

4. How to Submit a Site Amendment 

Other REGIS Quick Reference Guides are available here.