Clinical Trial Preparation Agreement ("Pre-Nup")
This can be used to cover the start-up fee and should be signed before or during the ethics review, before the main agreement is executed.
Clinical Trial Research Agreements
Medicines Australia Standard Form (Commercially Sponsored Pharmaceutical Studies)
CTRA - Medicines Australia Standard Form Mar 2017 (Word)
Medical Technology Association of Australia Standard Form (Commercially Sponsored Device Studies)
Clinical Investigation Research Agreement (CIRA) May 2017 (Word)
Medicines Australia Contract Research Organisations (CROs) acting as the Local Sponsor
CTRA - Contract Research Organisation acting as the Local Sponsor Mar 2017 (Word)
Medicines Australia Collaborative or Co-operative Research Group (CRG) Studies
CTRA - Collaborative or Cooperative Research Group (CRG) Studies Mar 2017 (Word)
Medicines Australia Phase 4 Clinical Trials (Medicines)
CTRA - Phase 4 Clinical Trials (Medicines) Mar 2017 (Word)
Medicines Australia Phase 4 Clinical Trials (Medicines) Contract Research Organisations (CROs) acting as the Local Sponsor
CTRA - Phase 4 Clinical Trials (Medicines) Contract Research Organisation acting as the Local Sponsor Mar 2017 (Word)
Investigator-initiated, company supported studies
A checklist has been developed for researchers to check the agreement and indemnity, if applicable, before they are submitted to the Office of Ethics and Research Governance.
If the checklist highlights any of the details as incorrect, please arrange corrections prior to submission of the documents.
The checklist does not apply to the investigator-initiated, company supported study template.
Research collaboration Agreement
Material Transfer Agreements (MTA)
A MTA governs the exchange of materials between two organisations, usually for research purposes and should be used for the transfer of tissue and other material. There are two types of MTAs: incoming and outgoing. An outgoing MTA is used when Alfred Health is providing materials to an external organisation.
An incoming MTA is provided by the relevant institution to an Alfred Health researcher requesting materials from an external source.
Amendments or Addenda to Agreements
Once the Agreement has been signed, any revisions to the Agreement are done via Amendment or Addendum to the Agreement. Many Sponsors have their own template. Alfred Health has created a template which can be used if the Sponsor does not have a template.