Ethics services
Facilitation of clinical research that will adhere to the highest ethical, medical, and scientific standards, without sacrificing time.
MUCTC helps companies and investigators manage a fast trial start-up process with standardised ethics documentation and streamlined processes.
CORE SERVICES
- Identify and engage with appropriate Human Research Ethics Committees (HREC) i.e. Bellberry, Monash University HREC, and Alfred Health HREC
- Preparation of ethics and governance submissions
- Develop participant consent processes
- Facilitating consumer and community involvement
- Adherence to local and international guidelines
- Safety monitoring
- Bespoke staff training through site initiation visits
- Generic research training through short courses e.g. ICH GCP certification and Clinical Trial Fundamentals.
ALL CLINICAL TRIALS MUST FOLLOW LOCAL AND INTERNATIONAL GUIDELINES, INCLUDING:
- International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines
- Declaration of Helsinki
- National Health and Medical Research Council (NHMRC) Australian Code
- NHMRC National Statement
- relevant privacy legislation.
Our team of experts efficiently develops and submits the documentation needed to ensure your trial is conducted to these standards.