Definition of site

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:

• the research impacts directly or indirectly on Austin Health patients- inpatients or outpatients
• Austin Health is funding the research directly
• the project uses significant Austin Health resources
• the research could impact on Austin Health's reputation
• Research partners wishing to access Austin Health staff and/or patients and/or their data and/or biospecimens. This is also applicable when our Research Partners act as Sponsor/Local Sponsor/ Administering institution for grants
• Work being conducted at any Austin Health location, including Austin Health Repatriation, Royal Talbot, and Austin Health Heidelberg are incorporated as a single site for research purposes.

Business details

Austin Health’s business details incorporate all of Austin Health’s campuses. Our business details for research agreements are

1. Business Name & Address: Austin Health, 145 Studley Road, Heidelberg, Vic 3084
2. ABN: 96  237  388  063
3. Signatory: The delegated person for research agreements changes depending on the project, and type of agreement.
   Please refer to our Research Agreement Standard Operating Procedure or contact research@austin.org.au to set-up a meeting to discuss your specific needs. We encourage early engagement to avoid lengthy delays and disappointment in research start-up times.
4. Digital Signatures: Austin Health uses Digital Signing platforms, such as Adobe Sign/DocuSign (or equivalent). Please refer to our Research Agreement Standard Operating Procedure for more information.

Getting an Agreement or Indemnity signed

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 research@austin.org.au.
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.

Avoiding delays in contract review and signing process

1. Send the contract with any context or supporting information, and provide the full agreement not just partial clauses without the full agreement.

2. Send the DocuSign/Adobe Sign request directly to the Office for Research research@austin.org.au.
   Please do not send directly to the signer as we have internal processes for the signer to know what they are signing off on, and importantly, if its within their signing delegation. Signatories rely on the internal processes to verify the relevant internal checks have happened prior to sign-off.

3. Use correct business name and details, correct study details, clear funding stream and relationships etc…..

4. Submit the research agreement and indemnities at the same time as the submission. 
   Separating this process out means providing full approval is delayed until the Office for Research has all the relevant information and documentation to review at once.

5. Keep the same signing requirements both before and after execution.
   Being asked to re-sign in another signing method to meet Sponsor requirements is not a collaborative way of working and does not acknowledge Austin Health is also an organisation with its own internal processes that must be adhered to.

6. Respect Austin Health legal advice.
   Requesting a waiver and or changing clauses means more time will be needed to consider the request.
   We are here to help, and here to ensure our patients receive the best of care, which is why we want a streamlined approach. However, we must also protect our patients, researchers, and organisations, and this is why our legal team will ask for changes and we will work collaboratively with the Sponsor to resolve the issue. Sponsors who are not willing to work in this collaborative way will experience delays.

7. Declare upfront all parties involved in the project, their relationship and discussion around who should contract with who, and the type of contracts each party should be entering.
   This is particularly relevant to investigator led research and de-centralised trials. Please note the Office for Research can advise on the best research agreements to use.

Feasibility

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 research@austin.org.au.

In the meantime, please contact the relevant area of the hospital to arrange a site feasibility assessment.