Site-Specific Assessment - Adding GH

If your project has obtained ethics approval from an external Human Research Ethics Committee (HREC) and will involve research activity at or through GH, you must complete an SSA (Site-Specific Assessment) before starting any research activity at Grampians Health (GH).

This is a research governance process, separate from ethics review, and ensures that GH can support the project safely and in compliance with legal and organisational requirements. You cannot commence research activity at GH until this step is complete.

Please review the fee schedule.

If fees apply, complete the Grampians Health HREC and Governance Fees Form and include this in your submission documents.

This form makes sure we have the correct information to issue the invoice.

Liaise with the lead research team to gain access to the SSA in ERM. (If the lead research team hasn’t used ERM to obtain their ethics approval, please contact us for further information about how to get around this.)

When you have access to the SSA, complete all the fields. Take care to:

• Ensure all members of the site research team are listed (anyone involved in data collection, recruitment, consenting, etc) and their investigator documents are uploaded to the application: CV, evidence of professional registration (e.g. current AHPRA certificate), and a GCP certificate for each investigator. For CVs, you can use this template [link to Researcher CV template Word file] if preferred to your regular CV.
• At question 3.4 (summary of site impact), carefully note what actual research activities will happen at GH, and who will do them.
• At question 4.1(b) (summary of recruitment), carefully note the local recruitment processes in detail.

Here is a list of documents often needed as part of an SSA submission:

• HREC approval letter listing GH as an approved site and all master versions of study documents.
• Victoria Specific Module (VSM) – addresses Victorian legislative requirements.
• Master Participant Information and Consent Forms (PICFs) as approved by the overseeing HREC
• Site-specific PICFs based on the Master PICFs:
  • Include GH contact details, GH logo, local investigator names, and local contact details for complaints (Manager, Research Ethics and Governance, 0417 733 520, ResearchEthics@gh.org.au).
  • Submit both a clean version and a tracked changes version (showing differences from the master PICF).
• Study protocol and any HREC-approved documents intended for use at GH.
• Insurance and indemnity documents (mandatory for clinical trials).
• CTN form (if applicable for clinical trials).
• Investigator CVs, professional registration, and GCP certificates for all GH investigators.
• Any advertising or patient-facing materials (if applicable).
• Fee form.

Most of the time when joining an external project, you’re collaborating with an organisation outside Grampians Health, and a research agreement is likely needed.

See more: Contracts and Agreements

Please feel free to contact us to discuss.

If any members of the research team are students (e.g. university students), some extra paperwork is needed to cover their involvement. This is:

• a copy of the Student Placement Agreement (fully executed, between the student’s university and GH)
• a letter/document/email from the university confirming that that student is indeed enrolled in the course specified in the placement agreement
• the student’s CV
• a Confidentiality Agreement signed by the student

The SSA/LRSSA, when completed with everything attached, needs to be signed by:

• The GH Principal Investigator
• The relevant Head of Department (HOD). If the HOD is on the project team, then they cannot sign approval – rather, the person to whom they report must sign as approving HOD.
• ERM has a signing function that should make this pretty straightforward for anyone who has an ERM account.

We will review the submission and let you know if anything’s missing. Otherwise, we will issue an authorisation letter – and organise for any research agreement to be signed by the correct person at Grampians Health – and you’ll be set to start your research!