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

A Notifiation of an Amendment to a Research Study is to be completed via REGIS

There are 3 types of Amendment Forms in REGIS:

  • Addition of a Site
  • Change of CPI/PI
  • General Amendment

Governance Forms

Reporting Forms

Progress reports

SAE Reporting

For HREC

  • All Significant Safety Issues (SSI's) via REGIS
  • Annual Safety Reports (to be emailed to the Research Ethics Office outside of REGIS)
  • Updated Investigator Brochures via a General Amendment via REGIS

For Governance (to be emailed to the Research Governance Office outside of REGIS)

  • All Significant Safety Issues (SSI's)
  • Any Local Serious Unexpected Serious Adverse Reaction (SUSARs/USADEs/URSAEs)
  • Any research-related events that met the definition of an incident (PD2014_004)

Other Templates 

Information Statements and Consent Form Templates