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Ongoing Management of More than Low Risk Research

Page Contents

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.

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

All submissions must:

  • Include the HREC reference number
  • Comply with the submission instructions 
  • Be submitted via ERM Applications 

AMENDMENTS

  • Must be approved prior to implementation

Changes to research protocol or study documents.

  • HREC Amendment Form
  • Revised protocol

 

If applicable

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

  • HREC Amendment Form

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 Form

 

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 Form

Refer to Adverse Events Reporting policy for reporting requirements

For clinical drug/device trials only

Six-monthly listings of all SUSARs or USADEs

  • SUSAR/USADE Line Listing Report Form

Must be accompanied by a statement from the study sponsor

For clinical drug/device trials only

Annual Safety Report

  • SUSAR/USADE Line Listing Report Form

Must be accompanied by a statement from the study sponsor

For clinical drug/device trials only

PROGRESS REPORTS

Annual Report 

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

Failure to submit an annual report by the September agenda closure deadline each year may result in approval being withdrawn.

The reporting period is the financial year. 

An interim report covering less than 12 months will be required for some projects in the first year. This should cover from the approval date until 30 June. 

Final Report

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

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

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 Report

 

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 Report

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.

Submit by the relevant HREC agenda closure deadline

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

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 Ethics Payment Form 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.