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Monitoring of Research Projects

Monitoring of research at Ballarat Health Services is undertaken through a number of different means:

1. HREC-Initiated Monitoring of Research Projects: where the HREC requests information from researchers about a project, e.g. annual project reports (or more frequent if required), final reports, safety reports, etc. All reports must be submitted to BHS Research and Ethics Service by the Principal Investigator. 

Annual Progress Report/Final Report

It is a condition of approval by the HREC that the Principal Investigator should submit a Progress Report for the study annually. If the study has been completed please use the same form to submit a Final Report along with any publications arising from the project.

Please refer to the attached “Flow Chart” to ensure compliance of the Annual /Final Progress Reports requirement for the continuation of your approved research project.

All progress reports must be submitted by the *30thApril each year. 

*Annual Reports for projects that have been approved in January – April in any year do not need to be submitted until 30 April the following year

Completed Annual Reports must have either an electronic signature attached or be signed and scanned prior to emailing toResearchEthics@bhs.org.au

 

Requirement to report- amendments, adverse events, other relevant safety information or other matters which may impact the conduct of the project.

2. Researcher-Initiated Monitoring of Research Projects: where researchers provide information to the HREC in a timely manner as the requirement to report arises, i.e. serious adverse events (SAEs) and other safety information, requests for amendment of approved protocol/documents, other correspondence.

In accordance with the National Statement Chapter 5.5.3, researchers also have a significant responsibility to monitor their research activity and must submit the following to the HREC, in relation to a given project:

  • Reports of Adverse/Serious Adverse Events/Suspected Unexpected Serious Adverse Reactions- and advise the HREC if the event has resulted in an amendment to the protocol and/or to the informed consent document.
  • Protocol amendments, updates to Investigator Brochures or changes to informed consent documents- from time to time, amendments to research projects are required. These are usually initiated by either the researchers or by external project sponsors (such as pharmaceutical companies) and may also require a change to the informed consent process.
  • Correspondence- notification of start of recruitment, project closed to accrual, protocol deviations or project suspended for a period of time, or any other matters that need to be reported to the HREC (including reason or discussion where appropriate). 

·        Annual Site Progress Report/Final Report

It is a condition of approval by the HREC that the Principal Investigator should submit a site progress report for the study annually. If the study has been completed please use the same form to submit a Final Report along with any publications arising from the project. The Victorian post-approval reporting forms are being reviewed in line with the new NHMRC guidance. Always access the forms from the Monitoring and Reporting page of the Clinical Trials and Research website each time you need them. The documents are frequently updated, and the most up to date versions are available on the website.

Please refer to the attached “Flow Chart” to ensure compliance of the Annual /Final Progress Reports requirement for the continuation of your approved research project.

All site progress reports must be submitted by the *30th April each year. 

*Annual Reports for projects that have been approved in January – April in any year do not need to be submitted until 30 April the following year

Completed Annual Reports must have either an electronic signature attached or be signed and scanned prior to emailing toResearchEthics@bhs.org.au

 

3. Office for Research-initiated: where the Office for Research requests further information about research staff or approved research projects, including auditing of research projects. 

Acknowledgement of Source http://www.mh.org.au/monitoring-of-research-projects/w1/i1015376/ accessed 1/5/2014

Research Amendments

From time to time, Amendments to research projects are required. These are usually initiated by either the researchers or by external project sponsors.

Notifications of protocol Amendments must be addressed to:

Diane Clingin
Research Integrity & Quality Officer (Research Governance Officer)
(Acting) Secretary, Ballarat Health Services & St John of God Human Research Ethics Committee
Medical Administration, Ballarat Health Services
Drummond Street North, Ballarat VIC 3350
ResearchEthics@ballarat.edu.au

Requirements:

One electronic copy of the Amendment  HREC Amendment Form with signatures explaining the background of the amendment, amended sections of the protocol, and any other relevant documentation. Changes should be highlighted for ease of review.

Please ensure that HREC Project Number, Amendment Number and date are included within the subject of the email.

If the Patient Information and Consent Form (PICF) is to be amended, please utilize “tracked changes” or underline all additions and changes to the text and strikethrough any deleted original text. One approved copy is to be provided, along with one tracked copy and a final 'clean' copy. A new version number and date is required in the footer of each page of the PICF. If new researchers are to be included, their names and contact details are required on the PICF.

An electronic copy of the HREC Amendment form (scanned original) and all documents included in the amendment ie. PICF, Protocol, CV's, Additional Personnel Form etc must also be emailed to: researchethics@bhs.org.au as a word doc in order to facilitate the review and comment process. 

Confirmation of payment. Please refer to the Research Fees Schedule on Research and Ethics Services website. 

Acknowledgement of Source http://www.mh.org.au/hrec-amendments/w1/i1001396/ accessed 1/5/2014