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Each clinical trial needs a protocol and a patient information and consent form, but most trials require other essential documents to conduct a clinical trial efficiently as specified by ICH GCP.
The Lead Investigator for a trial is ultimately responsible for these documents, though in practice the implementation of these processes often is strongly supported by clinical trial coordinators, technical specialists in clinical trial conduct.
If you wish to provide feedback or contact the team at the NSW Regional Health Partners Clinical Trials Roadmap please email ctroadmap@hmri.org.au
New South Wales Regional Health Partners respectfully acknowledge Aboriginal people as the past, present and future traditional custodians of the land and recognise their continued connection to land, waters and culture. We aim to partner with the Elders, community members and community controlled health services to improve health outcomes for Aboriginal people.
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