REGIS Quick Tips

REGIS 101: Quick Tips to get you started

Submitting a new study via REGIS:

  1. 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.

  2. Create a Project Registration within 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.
    • St Vincent’s Hospital including Sacred Heart Hospice and St Joseph’s Hospital come under SVHN (St Vincent’s Health Network).Note that separate SSAs are required for St Vincent’s Hospital and St Joseph’s Hospital.
    • A Cover Letter must be submitted, listing ALL sites and documents.
    • 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) and which phase (Phase 1,2,3,4) of trial your study is.
    • Upload Protocol without version and dates in the filename.

      While this can be done in the body of the document, the files must not be labelled with a date and version number:

      For example, please use “Protocol” or “Study Protocol”

      Do Not use “Protocol, V1” or “Protocol, V1 dated 13.12.18”

    • You will be issued a PID reference number.
    • A HREA cannot be initiated until this step is completed.

       

  3. Create a HREA within 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 contact listed in REGIS.
    • All investigators (if multiple) on HREA must have a REGIS account.

       

  4. Create an SSA within 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.
    • CPI must submit.
    • All Head of Departments and Head of Supporting Departments must have a REGIS account.
    • SSA can only be approved AFTER HREC approval.

       

  5. Approval / Post-Approval:
  • You will be issued:
    • Email Approval for HREC (ETH #)
    • Email Approval for SSA (STE #)
  • Within REGIS you will have 3 Reference numbers linked to your study (PDI # / ETH # / STE #).
  • Read your Approval Emails carefully as some unique special conditions may apply.
  • Annual Report due 1 year after HREC approval.
  • You must submit all amendments via REGIS.
  • SVH Research Office will not provide retrospective HREC and/or GOV approval.