The Melbourne Children’s ReseaRCH unit (MCRU) is a dedicated clinical research space in the RCH. Located on level 2 West, its primary use is for clinical trials run by staff of the Melbourne Children’s Campus, with a particular focus towards facilitating commercially sponsored clinical trials. MCRU is equipped in much the same way as a Day Medical Unit. The area meets all regulatory and safety requirements for the conduct of high risk and early phase drug trials.
The Department of Research Operations is responsible for the management of MCRU. The Director of Research Operations reports to the CEO and Board of RCH via the Executive Director Medical Services, Clinical Governance and Chief Medical Officer.
MCRU is overseen by the Clinical Nurse Consultant (CNC) for Research & Trials and the MCRU Clinic Coordinator, who is based in MCRU Monday-Friday and is available to assist with bookings, supplies and day-to-day issues. The coordinator can be contacted on x52260 or mcru@rch.org.au.
For requests to use MCRU, contact the CNC for Research & Trials.
Participant facing research happens throughout the RCH and Murdoch Children’s Research Institute. In addition to MCRU, there is a second dedicated research space for Melbourne Children’s Campus researchers on level 4west managed by the Melbourne Children’s Trials Centre. For requests to use the 4west research space, contact the Business and Operations Manager.
Key management, operational and infrastructure decisions for MCRU, are made in consultation with the Melbourne Children’s Trials Centre (MCTC) and other relevant stakeholders.
The MCTC provides investigators and industry sponsors with support for clinical research ranging from trials of novel therapeutic agents to large public health prevention trials. The centre has staff to support each stage of a trial from concept to protocol design through to trial conduct and analysis. For participant study visits the MCTC uses 2 west space (MCRU) at RCH and the level 4 west space (MCTC) at MCRI. The MCTC are the owners and are responsible for the day-to-day decisions for the 4 west research space.
Researcher responsibilities when using the MCRU space
- The
clinical trial / research project has current ethics and RCH governance
approval (including MCRU supporting department declaration sign off)
- Researchers
hold an RCH appointment (honorary or
paid)
- All
participants will have arm bands on
- All
drugs will be documented on EMR.
- All
bookings will be accurate on EMR, participants will be checked in and checked
out
- All
researchers will have completed their mandatory competencies, i.e.
- First 3-minutes (basic life support training)
- Hand hygiene
- Aseptic technique - All
researchers must have undertaken a local induction.
- All
researchers must have undertaken a local induction EMR training.
- Researchers
using the laboratory space must:
- have completed a face-to-face laboratory induction.
- have completed the online biosafety training.
- Follow
the RCH Procedural Pain Management Clinical Practice Guideline
- Prior to providing nitrous clinicians must have been accredited
- The sedation navigator is used if nitrous is being administered.
- Researchers
will create, update, and follow the following on EMR:
- Procedural
support plan
- Behavioral
support profile
- Researchers
will clean the participants’ bed spaces prior to and after departure with
Tuffie5 wipes.
- All
users of the space must join and interact with the MCRU team’s MS Team group to
keep abreast of changes and updates to the space and alert the Operations team
with any issues with the space.