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ORA

Seven Steps with Clinical Trials


 

7-Step Process for Issuing Work Orders Under the Tulane University & Tulane University Hospital & Clinic Master Clinical Trial Agreement

Step #1 - Submit Study Application to IRB, Department Notice to ORA of Proposed Study & ORA Negotiation of Sponsor Agreement:

  • Tulane’s PI/Coordinator submits a new study application to Tulane’s Biomedical IRB consistent with the IRB’s applicable policies.

  • The PI/Coordinator submits to ORA the following:

    • TUHSC Routing Sheet

    • Protocol and/or Summary

    • Draft Sponsor Agreement for Proposed Study (provide electronic copy ASAP)

    • Draft Informed Consent Form & Assent (if applicable)

    • Final Study Budget. No right of Hospital to review/approve study budget (unless PI or Co-PI is a TUHC employee)

  • ORA Negotiated Sponsored Research Agreement. This includes:

    • TUHC & TU must have identical sponsor indemnification

    • ORA executes sponsor agreement

Step #2 - IRB Approval of Protocol & Notice of Approval:

  • Tulane's IRB will notify the PI/Coordinator of approval & provide a copy of the IRB Approval letter.

Step #3 - Department Sends ORA Documents for Hospital Work Order:

  • The PI/Coordinator submits to ORA the following:

    • Departmental Cover Letter, to specify department approval, listing of documents submitted & clarify study type (e.g., all procedures paid for by sponsor versus all procedures paid for by subject/subjects payer versus mixed process)

    • IRB-approved protocol to the extent that the IRB makes any revisions

    • IRB-approved informed consent/assent including HIPAA consent

    • IRB Approval Letter

    • Hospital Meditech Forms (available online):

      • Meditech Client/Study Addition Form

      • Meditech Change Form - Note that the PI/Coordinator is responsible for accurate entry of procedure codes. While formal approval of Hospital Departments/Managers is not necessary, confer as needed to ensure accurate budget.

    • TUHC Investigational Study Questionnaire (available online)

Step #4 - ORA Notice to Hospital & Issuance of Draft Work Order:

  • The ORA Coordinator will submit the work order (via e-mail) to the Hospital Coordinator the following documents:

    • Department Cover Letter

    • Completed Work Order (executed by ORA on behalf of Tulane University) & all required appendices (approved & signed by ORA)

      • Appendix 1: IRB-approved protocol and/or summary of services, including IRB approval letter, & IRB approved informed consent/assent

      • Appendix 2: Study Budget, which is the TUHC Meditech Forms

      • Appendix 3: Standard Funding Agency Requirements

      • Appendix 4: TUHC Investigational Study Questionnaire

Step #5 - Hospital Reviews & Signs Work Order:

  • TUHC's Coordinator will confirm that the submission package is complete.  If so, the packet (including work order & all appendices) will be submitted to TUHC's senior management for final review & execution. This step should be completed within five (5) business days.

Step #6 - Hospital Establishes Clinical Trial Study Account:

  • Within 2 days of TUHC's signature of the work order, the Hospital will:

    • Provides copy of executed work order (excluding appendices) to ORA Coordinator

    • Enters study into Meditech Library

    • Submits required documentation to TUHC Billing Dept for account setup

    • Provides to PI/Coordinator study account number

Step #7 - Commence Subject Enrollment

 


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