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COVID-19

  • REG office

    The REG Office is transitioning back to working onsite at the Melbourne's Children's Campus. You can now contact us during work hours on our general number: 9345 5044. You can also email us at: rch.ethics@rch.org.au   Include a brief description of your query and quote the RCH HREC number in the subject heading of your email. 

    MCRI staff

    You can access the MCRI COVID Intranet Portal for information on MCRI-related work and research implications. This includes work documentation, working with research participants, travelling regionally and interstate from Melbourne. Please also follow the appropriate COVIDSafe  guidance and planning procedures.

    RCH staff

    You can access current COVID-related information via the RCH COVID-19 Intranet Portal and CEO Staff Forum updates. 

    For clinical trials being undertaken by The Royal Children's Hospital (RCH) Children's Cancer Centre please contact the Clinical Trials Manager on 9345 4592.

    More COVID-19 resources

    Breaches

    Protocol and GCP breaches and deviations do happen. The priority, in clinical research, is safety. For this reason you should report all significant safety issues, urgent safety measures and serious breaches impacting on patient safety and rights.

    If the breach is non-serious, in lieu of reporting individual events, you should submit a post COVID-19 deviation report after the situation has resolved.

    The report will require summary information on:

    • number of patients impacted,
    • changes to medication dispensing,
    • dose interruptions,
    • changes to visit schedule and visit activities,
    • use of external services (e.g. pathology, imaging, visit sites),
    • missing data

    Project notifications: Please submit on  ERM a Project Notification for any documents you would like formal acknowledgment from.

    Remote monitoring clinical trials during COVID-19

    There is no requirement to submit a remote monitoring plan to the RCH HREC or RGO for remote monitoring during the disruptions caused by COVID 19.

    There is no requirement for supplementary “Participant Informed Consent” for remote data monitoring. Every Participant Information and Consent Form (PICF) contains a statement on privacy and confidentiality stating that de-identified data will be shared with the sponsor. E.g ”By signing the consent form you consent to the study doctor and relevant research staff collecting and using personal information about you for the research project. Any information obtained in connection with this research project that can identify you will remain confidential. Your health records and any information collected and stored by the study doctor during the study may be reviewed (for the purpose of verifying the procedures and the data) by the ethics committee which approved this study or by regulatory authorities. In these circumstances, we will not collect or record your personal identifiable information.”

    For more information on onsite monitoring arrangements please see here for MCRI-related related clinical trials.

    Research and evaluation activity involving Victorian government schools and Victorian early childhood sites.

    All research and evaluation activity involving schools and early childhood services requires approval through the Department of Education and Training’s (the Department’s) Research in Schools and Early Childhood settings (RISEC) process.

    Subject to public health advice and operational guidance about external visitors to education settings, the Department’s RISEC process and all research and evaluation activity in education settings, is suspended for the remainder for 2021.