Research governance is a framework through which an institution is accountable for the scientific quality, ethical acceptability and safety of the research it allows to be conducted under their auspices.

What is site specific assessment?

Site specific assessment (SSA) forms part of good research governance and is an essential component of the responsible conduct of research. It enhances ethical and scientific quality, promotes good research practice and accountability, reduces adverse incidents and ensures lessons are learned, thus reducing the likelihood of poor performance and research misconduct.

Research governance is:

  • A framework through which institutions are accountable for the research they allow to be conducted under their auspices
  • A way of thinking about and managing research and applies to all individuals involved in research – staff and students, in all professional groups, no matter how senior or junior
  • About how research is conducted and about facilitating good (ethical and worthwhile) research
  • About responsibility and about managing risk

Before starting your submission, does the following circumstance apply to your research project?

Does your investigator-initiated clinical trial or multi-site study require the RMH to formally act as sponsor? If yes, action is required.

Submit a governance application for site specific assessment

Section Mandatory As applicable
Section 1: All components in this section are mandatory and must be completed
Section 2: For projects where ethics approval was not undertaken by the RMH HREC
Section 3: Projects that involve collaboration with any other organisations
Section 4: Projects involving Radiation and/or GMOs
Section 5: Applicable only to drug and/or device clinical trials
Section 6: Submission procedure
1a. Obtain a local HREC project number
1b. Victorian SSA form
1c. Statement of Approval forms and Departmental forms
1d. Project Budget Review
1e. RMH Participant Information and Consent Forms (PICFs)
1f. REDCap survey and the EPIC Electronic Medical Record (EMR)
1g. Research Governance Checklist for a Site Specific Application
1h. Fee payment

Section 2: Provide the following documentation where ethics approval was not undertaken by the RMH HREC

2a. Submit HREC application documents where ethics review was not undertaken by the RMH HREC

Section 3: Projects that involve collaboration with any other organisation

3a. Research Agreements

Section 4: Complete the elements below where projects involve radiation and/or genetically modified organisms

4a. Radiation element: Research involving ionising radiation
4b. GMO element: Projects involving Genetically Modified Organisms

Section 5: Complete the following section only if your project is a clinical trial investigating a drug and/or device

5a. Drug and/or Device Clinical Trial Documentation
5b. Site selection dates for externally sponsored clinical trials
5c. CTN information

Section 6: Submission Procedure

There are no submission deadlines for Site Specific applications however Site Specific applications for projects reviewed by the RMH HREC must be submitted within 12 months of obtaining ethical approval.

6a. Submit all documentation via email
6b. Submit documentation via ERM
Last updated 14 March 2023