REGIS Quick Tips


REGIS 101: Quick Tips to get you started

Please visit the REGIS website to access a series of Quick Reference Guides on how to successfully navigate the system:

REGIS Quick Reference Guides (QRGs)

Submitting a new study via REGIS

Create your unique Log In account:

  • You must use your work/student email address to set up the REGIS account.
  • No generic email addresses can be used       

Create a Project Registration in REGIS:

All information in the Project Registration must be correctly entered from the start as this PID cannot be edited.

  • List the CPI (Coordinating Principle Investigator) at time of project registration.
  • CPI must have a REGIS account.
  • CPI cannot be a student (refer to project registration 1.9.10).
  • 1.9.11 respond YES to CPI question.
  • All participating sites for which HREC approval is sought must be nominated at this stage.

Site Definition (as per PD2010_056):

A location must be listed as a study site if one or more of the following activities will occur at that location: 

  1. Enrolling participants into research (e.g. obtaining informed consent, screening);
  2. Carrying out protocol-specific research procedures with or on participants; and
  3. Managing and analysing data, tissue, and responses from surveys and questionnaires collected for or from research

This applies to PHOs, universities, MRIs and private sites.

  • St Vincent’s Hospital Sydney including Sacred Heart Hospice and the Kinghorn Cancer Centre come under SVHN (St Vincent’s Health Network).
  • A Cover Letter must be submitted listing ALL sites and documents and in the case of clinical trials, indicate the phase of the study.
  • You also must attach previous EMAIL correspondence with the Research Office directly prior to your REGIS submission stating what level of risk (LNR or full HREC).
  • Documents MUST be named according to the REGIS file naming conventions - please refer to the REGIS Quick Reference Guides (QRGs) on the REGIS website     
  • You will be issued a PID reference number.
  • A HREA cannot be initiated until this step is completed.        
 Create a HREA in REGIS:

  • You will be issued an ETH reference number (different to Project Registration number).
  • All questions must be answered.
  • The CPI and study contact must be clearly identified and contact details provided.
  • Study Contact/student can prepare the submission.
  • CPI must complete the final submit.
  • Communications are only sent to CPI and the study contact listed in REGIS.
  • All investigators (if multiple) on HREA must have a REGIS account.    

Create an SSA/STE in REGIS:

  • You will be issued a STE reference number (different to Project registration number and different to ETH number).
  • All questions must be answered.
  • Study contact/Student can prepare.
  • PI must submit.
  • All Head of Departments and Head of Supporting Departments must have a REGIS account.
  • SSA can only be approved AFTER HREC approval.    
  Approval / Post-Approval:
  • In REGIS you will have 3 Reference numbers linked to your study (PID # / ETH # / STE #).
  • Read your Approval Emails carefully as some unique special conditions may apply.
  • Annual Report is due 1 year after HREC approval.
  • You must submit all amendments via REGIS.
  • SVH Research Office will not provide retrospective HREC and/or governance approval.