Post-approval2020-12-16T12:20:24+10:00

Post-approval

While undertaking a research project, researchers have an obligation to monitor their projects and to report to the HREC via Ethics Review Manager (ERM).  Amendments, Annual and Final Reports, Safety Reports, SUSARs, DSURs, SAEs, Site Closures, etc. are submitted to the HREC via the ERM platform. Ethics and Research Governance approvals must be obtained prior to a research project commencing at a site.  Once these approvals are in place and the study has commenced, a Notification of Commencement of Research Protocol should be uploaded into ERM.  Details on uploading into ERM can be accessed in the ERM Researcher User Guide (available from a Queensland Health computer only) or ERM Quick Guides.

A condition of approval for all research projects approved by the Royal Brisbane & Women’s Hospital Human Research Ethics Committee (HREC) is that an Annual Progress Report must be submitted by the Principal Investigator by 30 April each and every year.

In Metro North Hospital and Health Service there are now no longer any expiry dates for HREC approved studies. The continuation of Ethical approval is contingent upon meeting the requirements as set out in the original approval letter and the receipt of an Annual Report, which is to be submitted for all studies by 30 April each year.  This eliminates requests for extensions for research projects , providing an Annual Report has been provided each year by 30 April.

Annual Report Process

  1. Please complete the Annual Report template ensuring all fields are completed and the form is signed by the Coordinating Principal Investigator.
  2. Access your HREA application in ERM and ‘Create Sub-Form’. The sub-form to be selected is ‘Project Progress Report Qld’. Please complete the progress report form in ERM and upload the Annual Report into this Sub-Form.
  3. Once completed and the Sub-Form has been signed, please select ‘Submit’ in the Actions Tile.
  4. Once submitted via ERM, please send your Annual Report in an email to: RBWH-Ethics@health.qld.gov.au to allow HREC to confirm successful submission via ERM.
  5. The HREC should be notified when a study has been completed, including if it is terminated prior to the expected completion date.
  1. Please note, an Outcomes Report will also be required at the completion of the study.

From time to time, amendments to research projects are required.  Amendments may include changes to the Protocol, the inclusion of additional sites and investigators and changes to the Participant Information Sheet & Consent Form, etc.   Researchers must notify the reviewing HREC of such changes. The majority of amendments are reviewed out-of-session and do not require review at the HREC meeting, nor submission by a certain deadline. When deemed necessary, amendments are sent to an HREC Sub-Committee out-of-session for review. The Sub-Committee will determine whether the amendment can be approved by the Chairperson/Sub-Committee review or whether more detailed consideration is required. If detailed consideration is required, the matter will be listed for discussion at the next HREC meeting.

Amendment Process (HREA):

  1. Download and carefully follow the RBWH Amendment Checklist
  2. Please include both tracked and clean copies of any documents to be amended, with an updated date and version in the footer of the documents. If additional study personnel are being added, please submit the ‘Change of Study Personnel Form’ and include a copy of their Curriculum Vitae.
  3. In the original application (HREA) in ERM, ‘Create Sub-Form’, which is located in the Action Tiles. The Sub-Form to be selected is ‘HREC Amendments Qld’. Please complete the amendment form in ERM and upload amendment documentation into this Sub-Form. Once completed and the Sub-Form has been signed, please select ‘Submit’ in the Actions Tile.
  4. Once submitted via ERM, please send the amendment documentation in an email to: RBWH-Ethics@health.qld.gov.au to allow HREC to confirm successful submission via ERM.

Amendment Process (Exemptions: Quality Assurance projects / Service Evaluations):

ERM unfortunately does not provide Sub-Forms for studies which have been deemed to be exempt from HREC review.  For amendments to exempt projects, please complete the following steps:

  1. Complete the RBWH Amendment Checklist. Please disregard “Submit application online via ERM”.
  2. Please include both tracked and clean copies of any documents which are being amended, with an updated version and date in the footer of the documents. If additional personnel are being added, please include a copy of their Curriculum Vitae for review.
  3. Please send an email with all amendment documentation to: RBWH-Ethics@health.qld.gov.au.  HREC staff will manually upload the amendment documentation into the exempt application in ERM.

Serious Breaches (Sponsor)

The NHMRC publication Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials involving Therapeutic Goods (2018) sets out the requirements for reporting serious breaches that occur in clinical trials.

A Serious Breach is a breach of GCP or the Protocol which is likely to affect, to a significant degree, the safety or rights of a research participant or the reliability and robustness of the data generated in the research project.

Serious breaches must be notified to the Royal Brisbane & Women’s Hospital Human Research Ethics Committee.

The submission must be completed by the sponsor when reporting a serious breach to the RBWH HREC or when a sponsor is providing additional / follow-up information following notification by an individual / institution of a confirmed serious breach.

Serious breaches at a site should also be reported by the site Principal Investigator to their site Research Governance Officer.

Suspected Breach report Form (Third Party)

A Suspected Breach is a report that is judged by the reporter as a possible serious breach, but has yet to be formally confirmed as a serious breach by the sponsor.

The submission must be completed when a third party (e.g. individual / institution) wishes to report a suspected breach of GCP or the Protocol. This should be reported directly to the RBWH HREC without reporting through the sponsor.

Non-serious Breach – Deviation Report

A Deviation is any breach, divergence or departure from the requirements of GCP or the Clinical Trial Protocol and does not have a significant impact on the continued safety or rights of participants or the reliability and robustness of the data generated in the clinical trial. Deviations that are considered to be a serious breach, should be reported using the  ‘Breach – Serious or Suspected – Report Form (HREC) Qld’ in ERM.

The Chairperson of the RBWH HREC

  • will review the impact on ongoing ethical acceptability of the research
  • will review the management of the breach
  • may provide ethical advice
  • will assess the corrective and preventative action outlined in the report

Breach Process

Serious, Suspected, Non-Serious/Deviations

  1. Provide a Cover Letter addressed to the Chairperson, Royal Brisbane & Women’s Hospital Human Research Ethics Committee, clearly outlining the breach.
  2. In the original application (HREA) in ERM, ‘Create Sub-Form’, which is located in the Action Tiles. The Sub-Form to be selected is ‘Breach – Serious or Suspected – Report Form (HREC) Qld’.  Please complete the applicable fields and upload the breach documentation into this Sub-Form.  At Question 1d please identify whether this is a serious breach or a suspected breach.  Once completed and the Sub-Form has been signed, please select ‘Submit’ in the Actions Tile.
  3. Once submitted via ERM, please send the breach documentation in an email to: RBWH-Ethics@health.qld.gov.au to allow HREC to confirm successful submission via ERM.

The Royal Brisbane & Women’s Hospital Human Research Ethics Committee complies with the NHMRC Safety monitoring and reporting in clinical trials involving therapeutic goods (2016) and the National Statement on Ethical Conduct in Human Research (2007).  It is essential that all Principal Investigators are familiar with and comply with the requirements of the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (November 2016).

The NHMRC publication sets out definitions of:

  • Serious Adverse Events (SAEs)
  • Serious Adverse Reactions (SARs)
  • Suspected Unexpected Serious Adverse Reactions (SUSARs)
  • Unanticipated Serious Adverse Device Effects (USADEs)
  • Significant Safety Issues (SSIs)
  • Urgent Safety Measures (USMs)

What should be reported to the HREC?

  • USMs instigated by the Site or Sponsor within 72 hours of becoming aware of the event
  • All other SSIs should be notified within 15 calendar days of the sponsor instigating or being made aware of the issue
  • An annual safety report including a clear summary of the evolving safety profile of the trial
  • Investigator Brochure amendments
  • Data Safety Monitoring Board (DSMB) reports

SAE/Safety Report/DSUR/SUSAR Process:

  1. Provide a Cover Letter addressed to the Chairperson, Royal Brisbane & Women’s Hospital Human Research Ethics Committee, clearly outlining the safety event you are reporting on.
  2. In the original application (HREA) in ERM, ‘Create Sub-Form’, which can be located in the Action Tiles. The Sub-Form to be selected is ‘Safety Report Form Qld’.
  3. Please complete the applicable fields and upload the safety report documentation into this Sub-Form. Once completed and the Sub-Form has been signed, please select ‘Submit’ in the Actions Tile.
  4. Once submitted via ERM, please send the safety report documentation in an email to: RBWH-Ethics@health.qld.gov.au to allow HREC to confirm successful submission via ERM.

A final report will be on completion or termination of the project.  This report should be provided to the HREC and relevant Research Governance Office.

Final Report Submission Process

  1. Please complete the final report template, ensuring all fields are completed and the form is signed by the Coordinating Principal Investigator.
  2. In the original application (HREA) in ERM, ‘Create Sub-Form’, which is located in the Action Tiles. The Sub-Form to be selected is ‘Project Final Report Qld’. Please complete the project final report form in ERM and upload the Final Report into this Sub-Form.  Once completed and the Sub-Form has been signed, please select ‘Submit’ in the Actions Tile.
  3. Once submitted via ERM, please send the Outcomes Report in an email to: RBWH-Ethics@health.qld.gov.au to allow HREC to confirm successful submission via ERM.
  4. Once reviewed by the Committee, the study will be closed, and no further submissions will be required to be made to the RBWH HREC.

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Contact us

Ethics & Research Governance Location: Lower Ground Floor Dr James Mayne Building Open: Monday-Friday 8:30am - 4:30pm

Ethics Phone: (07) 3646 5490 Email: RBWH-Ethics@health.qld.gov.au

Research Governance Phone: (07) 3646 2377 or 3646 4301 Email: RBWH-RGO@health.qld.gov.au

General enquiries Email: RBWH_Research_ESO @health.qld.gov.au