There are some additional agreements that will/may be required for investigator-initiated trials that include sites or service providers based outside Australia. These include:
Agreements with the In-Country Lead Site / Contract Research Organisation (CRO)/ Academic Clinical Trials Unit: The Sponsor-Investigator will need to delegate responsibilities for some tasks to either the In-Country Lead Site, a CRO or an Academic Clinical Trials Unit. This agreement must clearly detail the sponsoring institution’s delegation of responsibilities for tasks including (but not limited to):
Prepare country-specific Master consent form/s
Prepare ethics, regulatory authority and/or data protection authority applications
Obtain and maintain country-specific approvals for the duration of the trial
Maintain a country level TMF (or sub-section of the Master TMF)
Fulfil local safety reporting requirements
Fulfil local data protection authority reporting requirements
Fulfil local serious breach and urgent safety measure (USM) reporting
Carry out monitoring activities as directed by the trial’s monitoring plan including close-out activities and preparation for archiving
Material Transfer Agreement (MTA): Covering the transfer of any material/s such as bio-specimens/samples. If applicable to your clinical research and a statement not already contained within an existing Agreement.
Depending on the design of the study, other agreements may be required; for example, A Power of Attorney form (A2 Form) may be required in the Netherlands if engaging a participating site to act as a National Coordinating Centre (NCC)/In-Country Lead Site on behalf of other Dutch sites.
If you are the Sponsor-Investigator, you should engage the sponsoring institution’s legal team early so they can assess the insurance and business risk for the institution and advise you appropriately. They will also facilitate the preparation and negotiation of any required Agreements with third parties.
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