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.

LEADERSHIP

DR MARINA SKIBA

Our Ethics team is led by Dr Marina Skiba who has over 30 years of experience in clinical research with expertise in protocol development, ethics applications, data management and project co-ordination.

She has been involved in a variety of research, ranging from early and late-phase interventional studies and mechanistic trials to community-based observational research

A well-organised study set-up can lay the foundation for how an entire clinical trial is run.

We ensure you have the necessary ethics approvals, governance authorisations and processes in place and help bring supporting departments and external suppliers on board.

This all enhances the likelihood of a well-run clinical trial.

Book your complimentary initial consultation:

E: med-clinicaltrials@monash.edu

T: +61 3 9903 9300