RTO - Accredited Course
HLTHIR506B - Implement and Monitor Compliance with Legal and Ethical Requirements
Overview
Course features and benefits
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Testimonials
Overview
QCTN is Australia's first and only RTO to tailor a unit for Clinical Research Professionals who implement procedures and monitor compliance with legal and ethical requirements. HLTHIR506B – Implement and Monitor Compliance with Legal and Ethical Requirements is a nationally recognised unit from the health training package, and being a unique course in Australia, has been piloted with over 100 people to date.
This training is available as face to face sessions as well as self-paced modules, and has been specifically developed for three separate streams:
»HREC members
»Researchers (including Study Coordinators)
»Sponsors
Each stream has its own specific assessment.
Click here to see course dates and prices
Course Features and Benefits
This training course covers the Australian legal and ethical requirements for researchers and is delivered by a Registered Training Organisation, providing a Nationally Recognised Unit from the Health Training Package, accredited under the Australian Quality Training Framework.
The course covers the National Statement on Ethical Conduct in Human Research, The Australian Code for the Responsible Conduct of Research, ICH-Good Clinical Practice, the Clinical Trial Notification (CTN) and Exemption Scheme (CTX), The Queensland Guardianship and Administrative Tribunal and the National Privacy Principles.
This Unit has been developed (contextualised) so you have the ability to implement and monitor compliance with legal and ethical requirements as required in your role as Human Research Ethics Committee (HREC) Members/Administrators, Researchers/Study Coordinators or Sponsors/CRAs.
On completion of this course you should be able to:
1. Maintain ethical work practices
2. Maintain appropriate documentation
3. Maintain compliance with legal requirements
As an estimate, it should take approximately 40 hours to achieve the elements in this competency. Upon successful completion of the course requirements, participants will receive a Statement of Attainment for HLTHIR506B.
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