Qualifications and Credentialing

Recommended and mandated prerequisites for participation for investigators and coordinators in clinical trials include:


  • Curriculum Vitae (full and 1-page versions)
    • Trial sponsors, Human Research Ethics Committees (HRECs) or study grant funders will require, as a minimum, evidence of your Investigators’ professional experience and ability to deliver protocol requirements in a clinically appropriate way.


  • GCP (Good Clinical Practice) Certification
    • GCP certification is a formal recognition of a researcher’s knowledge and competence in their ability to adhere to applicable GCP guidelines in clinical trials. It is considered essential training for research professionals. Free training for NSW Health hospital staff and NSW-based medical research institutes is available here.  


  • Other trial specific training
    • Sponsors, supporting departments and/or affiliated organisations may have specific training you and supporting staff will be required to complete before being permitted to commence work on a clinical trial. This may include but is not limited to:
      • access to study specific databases
      • patient held devices
      • study specific devices e.g. Electrocardiogram, sphygmomanometer 
      • biological sample processing etc.


  • Australian Health Practitioner Registration
    • Research staff involved in trials (e.g. medical doctors or research nurses) require evidence of currency of authority to practice, i.e. in Australia their current AHPRA registration


Trial Management Documents


Insurance and Indemnification