Ongoing Management of Multi-site Research

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Ethical and Scientific Review | SSA Authorisation | Amendments | Safety Reporting | Reporting | Submission Requirements | Fees | Notification of Review Outcome

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

 

Important information for researchers 

As from 16 July 2018 the Ethics and Governance database and submission process has changed.  All applications and post approval documents will need to be created and submitted through the newly released Ethics Review Manager (ERM) Database for approval.  ERM replaces Online Forms.

Post-Approval Submissions

All post-approval submissions including amendments, progress reports, adverse events etc. must now be submitted through ERM. They can no longer be submitted by email.  

If you already have an Online Forms login and password it will transfer to ERM.  If your Online Forms login and password does not work, contact Helpdesk@infonetica.net

If you have not previously used Online Forms you will need to register in ERM.

The instructions on our website will be updated to reflect these changes.  

Where do I find ERM?

https://au.forms.ethicalreviewmanager.com/Account/Login

The staff from the Office for Research will be able to assist you.  Call Kim Sherry on 9784 2680 to make a time to call in or email Kim, KimSherry@phcn.vic.gov.au with your questions.

 

Ethical and Scientific  Review

Ethical and scientific review of post approval amendments and reports relating to projects reviewed under the Streamlined Ethical Review Process (SERP) including National Mutual Acceptance (NMA) is undertaken by the accredited Reviewing HREC that provided the original approval.

For multi-site clinical trials – processes and template are available from: http://www.health.vic.gov.au/clinicaltrials/

For multi-site health and medical research – processes and templates are available from: http://www.health.vic.gov.au/healthandmedicalresearch/index.htm

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

Research Governance / SSA Authorisation 

The requirements for submitting post approval documentation for Research Governance / SSA Authorisation at Peninsula Health are detailed below. 

All submissions must:

  • Include the HREC reference number
  • Comply with the submission instructions

AMENDMENTS

  • Must have Reviewing HREC approval and SSA Authorisation prior to implementation

Changes to research protocol or study documents

  • HREC Amendment Form (
  • HREC Approval Letter
  • Documents approved by reviewing HREC
  • Revised Peninsula Health versions of PICF(s) / Advertising
  • Protocol amendments initiated by a commercial sponsor will incur a fee. Please refer to the Governance Payment Form.

Include in amendment form:

  • Justification for this request
  • If existing participants are to be re-consented and the number of participants (where the amendment includes a revised PICF)

All revised documents must include:

  • Tracked changes (including additions and deletions)
  • A revised version and date

Changes to Research Personnel

 

Include a brief CV (full CV not required) for all new researchers who have not previously submitted a research CV

Investigator CV Template available

Request to extend the approval or re-activate the approval granted

  • HREC Amendment Form
  • HREC Approval Letter

Include in amendment form:

  • Original expected completion date
  • New expected completion date
  • Justification for why this request is required

SAFETY REPORTS

Adverse Events (AE) and Serious Adverse Events (SAE)

  • AE and SAE Report (Clinical Trials)
  • AE and SAE Report (Health/Medical)
  • HREC Acknowledgement

Refer to Adverse Events Reporting policy for reporting requirements

 

Suspected Unexpected Serious Adverse Reaction (SUSAR) and Unanticipated Serious Adverse Device Effect (USADE)

  • SUSAR/USADE Site Report (Clinical Trials)
  • HREC Acknowledgement

Refer to Adverse Events Reporting policy for reporting requirements

For clinical trials only

Six-monthly listings of all SUSARs or USADEs

Not required unless changes to study are indicated

Annual Safety Report

Not required unless changes to study are indicated

PROGRESS REPORTS

Annual Reports

  • HREC Progress Report – Site Report
  • Self Audit Tool for Researchers
  • HREC Acknowledgement

Failure to submit an annual report within 30 days of the due date may result in the withdrawal of site authorisation

  • Reporting period should comply with the reporting period specified by Reviewing HREC. Must not exceed 12 months in any report

 

Final Report

  • HREC Final Report
  • Self Audit Tool for Researchers
  • Copy of publications and/or presentations
  • HREC Acknowledgement

Submit a final report if project discontinued prior to completion or at the conclusion of the research projects

OTHER REPORTS

Protocol Violation  A failure to comply with the study protocol as approved by the HREC.  A violation is a serious non-compliance issue that may result in exclusion of a patient or their results from the study or have implications for participant safety

  • Protocol Deviation or Violation
  • HREC Acknowledgement

Submit report within 5 days if:

  • There are safety or ethical implications for the participants
  • The scientific integrity of the study is affected
  • The protocol methodology causes the protocol deviation/violation
  • The conduct of the study causes the protocol deviation to occur

Protocol Deviation – A less serious non-compliance with the protocol, which does not affect the scientific soundness of the study or the rights, safety or welfare of participants

  • Protocol Deviation or Violation
  • HREC Acknowledgment

Submit as an individual report or in summary format with the annual report submission including any actions taken to reduce recurrence

Submission Requirements

Post-approval submissions are to be submitted electronically via ERM Applications. Call Kim Sherry on 9784 2680 to make a time to call in or email Kim, KimSherry@phcn.vic.gov.au if you need assistance with setting up your application in ERM.

Ensure electronic files are submitted according to the Requirements for Naming Electronic Documents guidelines.

Scanned signatures are acceptable as long as the original signed documents can be provided on request (such as during an audit).

Research submissions will be returned if they do not comply with the submission requirements.

Fees

Protocol amendments initiated by a commercial sponsor will incur a fee. Please refer to the Governance Payment Form.

Notification of Review Outcome

The outcome of the research governance/SSA review will be emailed by the Office for Research

Research amendments must not be implemented until approval from Peninsula Health has been received.