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Ongoing Management of More than Low Risk Research (HREC)

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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:

 

The requirements for the submission of Post-HREC approval documentation are detailed below.

All submissions must:

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

AMENDMENTS

  • Must be approved prior to implementation

Changes to research protocol or study documents.

 

If applicable

  • Revised PICF(s)
  • Revised recruitment methods/advertising documents
  • Revised data collection tools
  • Revised Investigator’s Brochure or other study documents
  • Fee Form

Include in the amendment request:

  • Justification for this request
  • Ethical issues that may arise as a result of the changes
  • 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

Include in amendment form:

SAFETY REPORTS

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

 

Refer to Adverse Events Reporting policy for reporting requirements

 

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

Refer to Adverse Events Reporting policy for reporting requirements

For clinical drug/device trials only

Six-monthly listings of all SUSARs or USADEs

Must be accompanied by a statement from the study sponsor

For clinical drug/device trials only

Annual Safety Report

Must be accompanied by a statement from the study sponsor

For clinical drug/device trials only

PROGRESS REPORTS

Annual Reports (due on the anniversary of approval)

Failure to submit an annual report within 30 days of the due date may result in approval being withdrawn

Example:

  • Approval date: 1 Jan 14
  • First report due: 1 Jan 15
  • Reporting period: 1 Jan 14 -31 Dec 14

Final Report

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

 

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

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

Submission Requirements

Post-HREC approval submissions are to be submitted electronically by the relevant HREC agenda closure deadline

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

Email completed submission to ResearchEthics@phcn.vic.gov.au. Include HREC reference number in email subject line.

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 Fee Schedule for costs.

Notification of Review Outcome

The outcome of the HREC review will be emailed by the Office for Research within 7 days of the HREC meeting. 

Research amendments must not be implemented until notification of approval has been received.