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: firstname.lastname@example.org Include a brief description of your query and quote the RCH HREC number in the subject heading of your email.
You can access the
MCRI COVID Intranet Portal for information on MCRI-related work and research implications.
For an MCRI project (involving MCRI staff, areas,
participants) to ensure key operational and COVIDSafe practices are in place
for your project researchers must complete a Participant Research form and
COVIDSafe Subplan. Further further information and links can be found in the Clinical
and Participant Research section on the MCRI COVID Intranet Portal.
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
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.