| WH Standard Agreement Template | Research study type | Requirements |
Clinical Trial Research Agreement - Standard Form Click here for Medicines Australia Template | Commercially sponsored pharmaceutical trials | - Three (3) original wet-ink signed copies of the Clinical Trial Research Agreement (CTRA) signed by the sponsor and principal investigator.
- Note: For all CTRAs to which Western Health is a party, complete the "Institution" details on page one as follows:
Name: Western Health Address: 176 Furlong Rd, St Albans VIC 3021 ABN: 61 166 735 672 Contact for Notices: Research Program Director, Office for Research Phone Number: 61 3 8395 8073
- Any inclusions to Schedule 4/7 Special Conditions should be reviewed and approved by the Southern Eastern Border States (SEBS) otherwise, delays are expected for Western Health legal review. For more information regarding the process for SEBS approval please click here.
- Pharmacy fees; Where WH Pharmacy resources are required, the following clause is to be included under Schedule 2: "Where there is a discrepancy between the Statement of Approval Pharmacy Fees and those entered under Schedule 2 of the CTRA, the higher of the two fees will apply
Note: Ensure that you have attached email endorsement from the WH OfR regarding the accepted review of the agreement when formally submitting your application for governance review. Failure to provide the relevant information will result in delays in review and authorisation of agreements.
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Clinical Trial Research Agreement - Contract Research Organisations (CROs) acting as the Local Sponsor Click here for Medicines Australia Template | Studies where CRO acting as a local sponsor or where an institution is assuming CRO role |
Clinical Trial Research Agreement Collaborative or Co-operative Research Group (CRG) Click here for Medicines Australia Template | Collaborative or Cooperative Research Group (CRG) Studies |
Clinical Trial Research Agreement Medicines Australia Phase IV Clinical Trials (Medicines) Contract Research Organisation acting as Local Sponsor
Click here for Medicines Australia Template
| Phase IV trials - CRO acting as a local sponsor |
Clinical Trial Research Agreement Medicines Australia Phase IV Clinical Trials (Medicines) Click here for Medicines Australia Template | Phase IV trials- Commercially sponsored |
Clinical Trial Research Agreement – Investigator Initiated Study
download from right hand side link -pending
| Investigator Initiated Study/Trial |
Western Health Memorandum of Understanding (MOU) download from right hand side link | For low risk research or QA/QI collaborations that do not involve a financial transaction between parties | A minimum of 2 original wet ink signed agreements by the collaborator and if applicable, the Principal Investigator.
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Western Health Research Collaboration Agreement (RCA) download from right hand side link
| For Simple Collaborative studies/ investigator initiated research that may involve financial transactions between parties |
MACH collaboration Agreement
download from right hand side link
| Investigator Initiated research collaborations between two or more MACH members. It accommodates the parties making "Materials" available for research collaborations and for small to medium amounts of funds to be expended by the parties. MACH Partner List |
