Join us for Drop-in sessions!!!

When:       every Wednesday from 9:30am - 10:30am and Fridays 10:30am - 11:30am. 

Where:      our office is located on Level 4, South Building. 

What to expect: the team are here to discuss your study and answer questions. 

Prof Robyn Langham - TGA Chief Medical Adviser

Congratulations to Professor Robyn Langham, Chair of the RCH Human Research Ethics Committee (HREC), who has been appointed to the role of Chief Medical Adviser at the Therapeutic Goods Administration (TGA). Professor Langham will take on the tasks of providing expert medical advice on current and emerging issues to key stakeholders including government, health care professionals, consumer organisations and industry. As this position is part-time, Professor Langham will continue as Chair of the HREC, albeit with the need to defer responsibility of any work that relates to the function of the TGA. 

Ionising Radiation  

The Radiation Health Committee have agreed to recommendations made to facilitate the National Mutual Acceptance program when multiple sites Radiation Safety Letters were previously required for HREC review, as often differed as Standard of Care differs across sites. The Lead HREC will review one Radiation Safety letter (ideally that with the highest dose) and consider the risks and benefit to the participants based on that report. The approved Risk Category will then be included on the Ethics Approval Letter (Category I, IIa, IIb or III) . The Governance Officer at each site will review their own site’s Radiation Safety letter as part the Site-Specific Application. Site governance authorisation will only be provided if the Risk Category is at or below that which was ethically approved. If not, the Radiation Safety letter (with a higher dose level) must be submitted back to the HREC as an amendment for re-consideration. 

MCRI Sponsorship Committee

The MCRI sponsorship committee needs to approve new investigator initiated clinical trials that are not commercially or collaboratively group sponsored. The committee meets on the first Monday of every month to review new trial applications for sponsorship.

The committee's role is to identify any requirements for extra indemnity, insurance and contracts for a trial, on a case by case basis. They will advise the Sponsor-Investigator, and REG where necessary, of these requirements. 

For this review, you will need to submit the following documents at least 10 working days prior to the next Sponsorship Committee Meeting: 

• MCRI Sponsorship Committee Application Coversheet and Risk Management Table
• Protocol (current draft is acceptable) 
• Data Management Plan
• Data Sharing Plan
• Monitoring Plan
• Budget
• Funding source: evidence of trial funding e.g. NHMRC letter, contract with international sponsor. 

Applications should be emailed to mctc@mcri.edu.au.  Once your application has been received, your application will be tabled for consideration at the next Sponsorship Committee meeting. You will be asked to attend the meeting to discuss your application and answer any questions raised by the committee during their review.  

They review and approve sponsorship for Investigator Initiated Trials (IIT) conducted at sites within Australia. For sponsorship of international sites, additional consideration is required by the sponsorship committee. Investigators requesting sponsorship for an IIT must be employees of, or have honorary appointments with, The Royal Children's Hospital (RCH) and/or MCRI.

MCRI cannot support individual members of staff to personally act as the sponsor of a clinical trial. This requires Investigators to submit their IIT protocol and supporting documentation to the MCRI Sponsorship Committee for review and approval before obtaining HREC approval and prior to commencement of the project.

If Investigators are unsure if the sponsorship process applies to them, please refer to the:

• MCRI Sponsorship Standard Operating Procedure
• MCRI Sponsor Application Form  
• MCRI Sponsorship Approval FAQ

Please contact the Director of the MCTC for clarification, guidance and new submissions.

Please note: the Sponsorship Committee meeting dates can be found here or via the New Applications page. 

Clinical Trials involving GMOs

MCRI has developed a process for using Genetically Modified Organisms (GMOs). It must be followed by researchers intending to conduct clinical trials involving GMOs at Melbourne Children's Campus. Please refer to the below link on the process: 

IBC - Performing Human Clinical Trials involving Genetic Modified Organisms (GMOs) in Melb Children’s Campus – A Process

Quality Improvement Projects 

Projects that are quality improvement or assurance, rather than research, (see quality project) do not require research ethics approval, and should instead be submitted through the organisational project management process. This process replaces the previous process of registering quality projects on RiskmanQ.

If you are not sure whether your project is quality or research, please refer to the quick survey found in Step 2 on the Getting Started - Project Management page. 

Consent forms and EMR

Participant information statements and consent forms for clinical trials (and other clinical research as appropriate) should be scanned into the EMR.

After consultation with Health Information Services, it has been clarified that researchers should send a high quality copy of the consent document for scanning into the EMR. This does not need to be a certified copy. Original consent documents should always be retained within the site file. To ensure transparency and accountability, it is strongly recommended that researchers mark the original as having been sent to EMR to ensure multiple copies are not sent for scanning.

Please note, if you send the original document to EMR for scanning, it will be archived off site and will not be retrievable.

A SOP is currently being prepared to detail this process, however in the interim, it is recommended that researchers amend current processes to incorporate the above.

If you have any queries relating to this matter, please contact REG on 9345 5044 or rch.ethics@rch.org.au

Good Clinical Practice training 

If you are conducting a clinical trial at the Melbourne Children’s Campus, you must provide evidence that the investigative team has successfully completed TransCelerate accredited GCP training in order to obtain governance authorisation. This includes all investigators, study coordinator, research nurse, pharmacist, and anyone undertaking a trial-specific procedure that is additional to standard of care. It is strongly recommended that all investigators for other clinical research also complete GCP training.

MCRI have a number of GCP workshops scheduled throughout the year. These are free for campus staff & students. PIs, and any other members of the research team, are welcome to enrol in one of these at mcri.edu.au/research/facilities-resources-and-training/clinical-research-development-office-crdo/crdo-workshops.

Other free courses include: 

• NIDA Clinical Trials Network (part of the National Institutes of Health in the US) is now Transcelerate-recognised and we are recommending this to those unable to attend our face-to-face CRDO workshops. Go to https://gcp.nidatraining.org/
  
• Australian Clinical Trials Education Centre (A-CTEC) – GCP training designed for Australian audiences is provided on-line at no cost through A-CTEC (you just need to set up a free account) https://actec.myopenlms.net/enrol/index.php?id=156 - this course is Transcelerate-recognised
• Contact CRDO ( crdo.info@mcri.edu.au) if you would like to take this option and they will provide you with log in / registration details