Forms and Templates

As of February 2014 the Research Ethics & Governance Office no longer requires paper copies of submissions and subsequent correspondence with the exception of Site Specific Regulatory Documents ie. CTN’s, Indemnities, CTRA’s – Hard signed copies still required.

All documents should be submitted via the new Research Ethics and Governance System (REGIS) as part of the application process.  

Ethics Forms

Suggested Protocol Templates for Clinical Trials

Post Approval Forms

  • Variation Application Form (only to be used for projects that have been approved outside of REGIS. Please note: this will change once all applications have been migrated into REGIS whereby all post approval activities will then be required to be submitted via the new IT Platform).

Governance Forms

Due to the change in IT platforms from Online Forms to REGIS there will be a transition period for site applications. Please contact your local Research Governance Office before completing a Site Application for advice on which platform to use to create your site application.

Reporting Forms

Progress reports

SAE Reporting

Other Templates 

Information Statements and Consent Form Templates