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Ongoing Management of Low and Negligible Risk Research (LRRS)

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Amendments | Safety Reporting | Reports | 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-LRRS approval documentation are detailed below.

All submissions must:

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

AMENDMENTS

  • Must be approved prior to implementation

Changes to research protocol, conduct or direction of the study.

If applicable

  • Revised PICF(s)
  • Revised recruitment methods/advertising documents
  • Revised data collection tools

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 to re-activate the approval granted

 

Include in amendment form:

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

SAFETY REPORTS

Adverse Events / Incidents occurring to participants

Incidents resulting in harm must be notified to the Office for Research within 24 hours.

Reporting in VHIMS may be required

PROGRESS REPORTS

Annual Reports (due on the anniversary of original 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Failure to submit an annual report within 30 days of the due date may result in approval being withdrawn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 2014
  • First report due 1 Jan 2015
  • 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

Submission Requirements

Post-LRRS approval submissions are to be submitted electronically by the relevant LRRS submission deadlines.

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

Email completed submission to ResearchEthics@phcn.vic.gov.au. Include LRRS 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

Fees are not applicable to LRRS review. 

Notification of Review Outcome

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

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