Legal and regulatory
Formal agreements should be established for commercially sponsored research, research with collective or collaborative groups and research involving collaboration between institutions (locally and internationally).
The quick reference table outlines the agreement, indemnity and insurance arrangements by type of research.
Pharmaceutical templates and compensation guidelines are issued by Medicines Australia.
Device templates and compensation guidelines are issued by the Medical Technology Association of Australia (MTAA).
Research involving a device, medicine or biological not listed on the Therapeutic Goods Administration's ARTG (i.e. an "unapproved therapeutic good") or an approved device, medicine or biological but used outside of its marketing approval, requires a clinical trials notification (CTN).
The name of the parties should be consistent across all documents, for example, the name of the local commercial sponsor should be the same on the CTN, agreement, indemnity and insurance.
All legal documents are to be submitted, along with the research funding contract checklist, to the Office of Ethics and Research Governance for signing. Researchers cannot sign on behalf of Alfred Health.