Multi-site Research

Page Contents

Ethical and Scientific Review | SSA Authorisation | Application for SSA Authorisation | Submission Requirements | Fees | Notification 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

 

 

 

 

 

 

 

 

Coversheet for New Research Governance Applications

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 NEAF or LNR Form submitted to the Reviewing HREC (help information available from website)

Victorian Specific Module (VSM) Section 4

This is additional to the VSM submitted to the reviewing HREC.  VSM Guidelines to assist completion are available.

Participant Information and Consent Forms (PICFs)

  • based on HREC approved Master PICF(s)

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.

Templates for Clinical Trials

Templates for Health and Medical Research

Investigator CV for all researchers who have not previously submitted a research CV.

Investigator CV Template available

Full CV is not required

Fee Form

Refer to the Fee Schedule and complete relevant section if applicable.

RESEARCH GOVERNANCE SUPPORTING DOCUMENTS

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

Clinical Trial Research Agreement (CTRA)

Standard templates available

Required when a trial has a commercial, Contract Research Organisation (CRO) or Collaborative Research Group (CRG) sponsor.

A CTRA is also required for multi-site investigator-initiated clinical trials.

Only the standard CTRA templates will be accepted.

Collaboration Agreement

May be required for non-clinical trials. Contact Manager Office for Research

Clinical Trial Notification (CTN) Form

For projects involving the use of unapproved therapeutics goods. See TGA guidelines

Indemnity

Standard templates available

Required when the trial has a commercial, CRO or a CRG (registered as a business) sponsor. Indemnity is not required for university or health service CRG.

Only the standard form of indemnity will be accepted.

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.

Electronic Submission

The electronic submission involves

  • Uploading all supporting documents to the SSA Form
  • Generating the SSA submission code

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

Email the SSA submission code to rgo@phcn.vic.gov.au with the HREC Reference number and study title included in the email. 

Hard Copy Submission

The hard copy submission is to be delivered/sent to the Office for Research.  Documents required in hard copy include:

  • One copy of complete application (including documents approved by Reviewing HREC) with relevant signatures
  • Required number of copies (as applicable) of
    • CTRA – signed by sponsor and Principal Investigator
    • Indemnity – signed by sponsor
    • CTN – signed by Reviewing HREC and Principal Investigator

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

Fees

Peninsula Health charges a Research Governance Review Fee. Refer to the Fee Schedule.

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 approval 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.