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Austin Health is co-located with Campus partners (Universities and Medical Research Institutes).
This forms a collaboration between scientists, researchers and health professionals and allows research to be translated into clinical care.
Austin Health is the custodian of clinical care and patients and therefore forms the “site” for our research, which means Indemnities and Research Agreements should be with Austin Health acting as the site.
Our Universities and Medical Research Institutes are the custodian of research and researcher training and therefore form the “administrating institution and/or sponsor” for our investigator initiated research. This arrangement is set out in Research Partner Principles.
For Sponsors and our Research Partners, please see below for the definition of activities covered under the auspices of Austin Health.
Austin Health is considered a site when a research project fits into one of the following criteria:
Austin Health’s business details incorporate all of Austin Health’s campuses. Our business details for research agreements are
At Austin Health, all research agreements and indemnities are signed using AdobeSign® BioPharma settings. These settings are 21 CRF part 11 compliant which means they meet all international legislative and regulatory signature standards.
Austin Health accepts partially executed research agreements and indemnities that have been signed using equivalent BioPharma settings. The most common is DocuSign. There is no legal requirement to sign using the same platform. This means if the BioPharma settings are applied by each party, an agreement signed in DocuSign by one party can be signed in AdobeSign by another party because the signing method is the same.
Austin Health no longer accepts DocuSign or AdobeSign requests directly from the Sponsor to the signatory. This is because our internal signing processes cannot be followed. These requests take longer to action because they are outside of our internal processes to review and execute agreements. This is in line with standard contract practice that each organisation signs using their own internal process.
From November 2022, wet ink signatures are no longer accepted at Austin Health. If Sponsors have a particular requirement, they should contact Austin Health Office for Research to discuss firstname.lastname@example.org.
Please note Principal Investigators and Study Coordinators/Area managers have no authority to discuss signing methods with Sponsors. This is because signing methods and delegations of authority are part of our organisational governance. The Office for Research acts on behalf of our organisation to ensure appropriate governance is followed. This means signing methods and platforms are not a per project/research team matter.
Per standard contract management practice, a word version where tracked changes can be made should be supplied to the Office for Research. This allows the office to provide any amendments prior to preparing to sign-off. We won’t hold up any agreements that are partially executed. At the risk to the Sponsor, Austin Health can accept a partially executed copy of research agreements. If corrections are needed, the Office for Research will ask for these to be made, another tracked copy sent to confirm corrections prior to moving ahead for signing.
As part of our commitment to National Clinical Trials Framework, we are working on a streamlined feasibility process. If you have ideas, please email them to email@example.com.
In the meantime, please contact the relevant area of the hospital to arrange a site feasibility assessment.