MCRU staff have experience with protocol development. Protocols are developed to ensure all studies are carried out in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Research Involving Humans, The Declaration of Helsinki and Therapeutic Goods Administration (TGA) Note for Guidance on Good Clinical Practice (GCP) (CPMP/ICH/135/95).
Case report forms
MCRU can assist in CRF development to ensure that all relevant data is collected for analysis of each clinical trial. Staff have extensive experience working with a variety of CRF designs, including electronic formats.
Our study participants are drawn from the Hospital population as well as a community trial network. Resources such as general practitioners, maternal and child health nurses, day care facilities and schools are utilised.
The MCRU staff are skilled in evaluating study protocols to assess their feasibility and to identify any potential problems in the study which may hinder the recruitment process if the studies are too difficult.
A purpose-built clinical trials area is now well established. We provide a non-threatening and family friendly environment to clinical trial participants in both inpatient and outpatient settings.
Our area contains:
- Kitchen facilities
- 3 exam/treatment rooms (exam beds/cots, sphygmomanometer, writing desk)
- A large treatment area/patient lounge
- Fully stocked resuscitation trolley
- Pathology processing area
- Refrigerated centrifuges (maintenance details available on request)
- -80oC Freezer (temperature and maintenance logs available on request)
- Monitored 2–8 degree Celsius refrigerator (Temperature and maintenance logs available on request)
To make a booking contact Barisa Kedir for further information.