Multi-site Research

Page Contents

Ethical and Scientific Review | SSA Authorisation | Application for SSA Authorisation | Submission RequirementsNotification of Review Outcome | After Approval

Please note that this section does not apply to the following types of studies:

Peninsula Health is a participating organisation in the Streamlined Ethical Review Process (SERP) including National Mutual Acceptance (NMA) for eligible multi-site research projects.

As a participating organisation, Peninsula Health accepts the ethical and scientific review conducted by a Human Research Ethics Committee (HREC) certified by the National Health and Medical Research Council (NHMRC) that is accredited to review applications under the streamlined systems. 

The Peninsula Health HREC does not undertake ethical and scientific review under these systems.  The Manager Office for Research undertakes Research Governance/Site Specific Assessment (SSA) to determine if projects should be authorised to commence at Peninsula Health.  Submission deadlines are not applicable to SSA.

Ethical and Scientific Review

Ethical and scientific review of projects reviewed under SERP including NMA is undertaken by one of the accredited reviewing HRECs.

For multi-site clinical trials http://www.health.vic.gov.au/clinicaltrials/

For multi-site health and medical research http://www.health.vic.gov.au/healthandmedicalresearch/index.htm

Principal Investigators must be aware of their responsibilities under these review systems.

SSA Authorisation

Under SERP including NMA a multi-site research project cannot commence at Peninsula Health until:

  1. Approval has been granted by the reviewing HREC (Peninsula Health must be listed as an approved site); and
  2. Research governance/SSA authorisation has been issued by Peninsula Health.

SSA occurs once Reviewing HREC approval is granted, although some documents (such as Clinical Trial Research Agreements, Indemnity and Insurance documents) can be reviewed prior to final HREC approval.

Application for Research Governance/SSA Authorisation

Below is a list of the documents required for submission. Incomplete applications will not be accepted for review.

All applications must:

  • Include the HREC reference number
  • Contain documents which have a version number and date (no draft documents will be accepted)
  • Comply with the documents approved by the reviewing HREC
  • Comply with the submission instructions

RESEARCH GOVERNANCE APPLICATION

  • Mandatory for all applications

 

 

 

 

 

 

 

 

SERP/NMA Coversheet

To be signed by the Principal Investigator. Provide a list of all documents included in the submission.

Reviewing HREC Approval Letter(s)/Certificate(s)

  • Original Approval
  • Approval of Amendments

 

Must clearly list that ethics approval has been granted for Peninsula Health sites.

If study has been approved by an interstate HREC, ensure VSM (see below) has been reviewed and approved and PICFs are compliant with DHHS templates.

Reviewing HREC Approved Documents

All documents approved by the reviewing HREC are to be supplied (except for site specific documents which do not relate to PH sites).

Site Specific Assessment (SSA) Form

To be completed through Australian Online Forms for Research website.

Must be linked to the HREA or LNR Form submitted to the Reviewing HREC (help information available from website).

Participant Information and Consent Forms (PICFs)

Master PICF version approved by the reviewing HREC is to be modified to create the Peninsula Health site specific PICF. PICFs which are not compliant with the templates from DHHS will not be accepted.

Peninsula Health Logo’s and site specific contact information will be supplied by contacting the Office for Research.

Investigator CV for each researcher (if one has not been submitted in the previous 3 years).

Investigator CV Template available.

Full CV is not required.

Governance Payment Form

Refer to the Payment Form and complete relevant section (if applicable).

RESEARCH GOVERNANCE SUPPORTING DOCUMENTS

  • Depending on the project, some or all of these documents may be required

Resource Centre Declaration and Service Request Forms

Forms to be used by the service department to determine the cost of the services requested.  These are not considered as part of the research governance review but are to be sighted as part of the application.

Projects involving ionising radiation

Contact the Manager Office for Research.

Clinical Trial / Collaborative Research Agreements

Contact the Manager Office for Research if you are unsure if this is required for your project.

Clinical Trial Notification (CTN) is completed online.

For projects involving the use of unapproved therapeutics goods. See TGA guidelines. Contact Manager Office for Research.

Indemnity

Contact the Manager Office for Research if you are unsure if this is required for your project. 

Certificate of Currency

(Insurance)

Must provide sufficient evidence that the commercial sponsor or CRO meets minimum insurance requirements.

Submission Requirements

Submission of research governance/SSA applications involves both an electronic submission and a hard copy submission.

Submit electronic application via Online Forms website, ensuring all supporting documents have been uploaded. 

All electronic files must be labelled according to the Requirements for Naming Electronic Documents guidelines.

Submit hard copy documents to the Office for Research.  Documents required in hard copy include:

  • Required number of copies (as applicable) of
    • Agreement – signed by sponsor and Principal Investigator
    • Indemnity – signed by sponsor

Electronic signatures are preferred on application forms. Scanned signatures are acceptable as long as the original signed documents can be provided on request (such as during an audit). Original signatures are required on CTRA and Indemnity documents.

Notification of Review Outcome

The Manager Office for Research undertakes Site Specific Assessment of the application and liaises with the principal investigator/study coordinator to ensure compliance with research governance requirements. 

Multi-site research must not commence until a formal signed Site Authorisation Letter from Peninsula Health has been received.

After Approval

Researchers must comply with the monitoring and reporting requirements of

  • The Reviewing HREC; and
  • Peninsula Health

Requirements and submission templates are available from here.