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PROCEDURES FOR PROCESSING AGREEMENTS & CONTRACTS


Instructions are provided below for the submission of draft agreements and execution of final agreements.
 

A. Submit Draft Agreements for Review 

  1. Investigator requests and receives an editable (Word), electronic version of the draft agreement from the sponsor or external party.
       
  2. If the sponsor/external party does not have an existing agreement, use the appropriate template from those listed here.
     
  3. Review the agreement and make any changes (using the “track changes” function) as appropriate.
     
  4. Using these instructions (text or video), submit the draft agreement in the Kuali Negotiation Module for review by the the appropriate Office.
     
    AGREEMENT TYPERESPONSIBLE OFFICE
    Material Transfer Agreement (MTA)#Office of Innovation & Partnership (OIP)
    Non-Disclosure Agreement (NDA)OIP
    Data Use Agreement (DUA)Office of Grants & Contracts (OGC) @ Office of Research Services
    Clinical Trials Agreement (CTA)OGC
    Other Research AgreementsOGC
    # For Material Transfer Agreements (MTAs), please make sure to include a completed and signed copy of the appropriate Material Transfer Initiation Form, found here.
  5. Continue review and submission of any revised versions in Kuali (as in Step A4) until all parties have agreed to the final language.
     

B. Obtain Signatures on Final Agreements

  1. Agreements Negotiated by OIP: OIP will coordinate acquisition of all signatures and upload a fully-executed agreement in Kuali.
     
  2. Other Agreements
     
    • OGC will accept and use wet ink signatures or authorized (DocuSign, Adobe Sign, Adobe Pro) electronic signatures.
       
    • Whenever possible, have all other parties (e.g., UMC, Sponsor) sign the agreement prior to routing as described below. Otherwise, you may submit the unsigned agreement for LSUHSC signature.
       
    • If any party requires a hard copy of the agreement with wet ink signatures, please inform OGC of this requirement and bring hard copies of any partially-executed agreements to the Office of Research Services. If no parties have signed the agreement, then OGC will print the agreement submitted in Kuali for wet ink signatures.
       

C. Route Documents for Institutional Approvals (agreements reviewed by OGC)

  1. Submit the routing packet to OGC: Submit the routing packet, including the agreement (not executed or partially executed) and the associated routing documents as listed in the table below, via the Kuali Proposal Development Module as described here.
     
    Agreement Type ►

    Clinical Trial 

    Research Grant AwardData Use Sub-contractAmend-ment

    Routing Docs 

    Agreement

    XXXXXX
    Completed Contract Terms & Conditions ChecklistX     
    Payment ScheduleX     
    Clinical Trial Revenue/ Expense BudgetX     
    Standard Budget** XX XX
    ProtocolX     
    Work Plan XX X 
    Award Notice  X X 
    IACUC/IBC/IRB Approvals**XXX X 
    Copies of Original Agmt & Amendment     X
    Copy of Original Proposal#    X 

    **These items are built into the Proposal Development form and separate attachments are not necessary.
    #Submit only if the original proposal was created outside of Kuali.
     

  2. Disposition of agreement after LSUHSC approval of routing packet: 
     
    • Fully-Executed Agreement (all parties have signed): OGC will upload an electronic copy of the agreement in the Negotiation Module and notify the PI and the person submitting the original draft agreement.
       
      • When applicable, OGC will notify the Department/PI that hard copies of the agreement with wet ink signatures are ready for pick up.
         
      • Once the agreement is fully executed, departments are responsible for submitting a sponsored project number setup request, including all required attachments, to SPA (nosponproj@lsuhsc.edu) so that a PeopleSoft account number can be established.
         
    • Partially-Executed Agreement (Sponsor and/or other parties have not signed): OGC will upload an electronic copy of the agreement in the Negotiation Module and notify the PI and the person submitting the original draft agreement. 
       
      • Department/PI will obtain the sponsor’s and/or external party’s signature(s).
         
      • When applicable, OGC will notify the Department/PI that hard copies of the agreement with wet ink signatures are ready for pick up. The Department/PI will facilitate full execution of the agreement.
         
      • Department/PI will upload an electronic copy of the fully-executed agreement in the Negotiation Module and notify OGC. This is a required step. State auditors require a central repository of all fully-executed research agreements. Continuing non-compliance with this requirement may result in suspension of future review and approval.
          

D. Concurrent Review

  1. If the research study under consideration involves human subjects and/or use of animals or biohazards, application(s) to the IRB, IACUC and/or IBC should be prepared concurrent with contract negotiations in order to expedite research approval.
     

E. Resources

  1. Agreement templates
     
  2. Clinical trial revenue-expense budget template
     
  3. KUALI Quickguide: Using the Kuali Negotiation Module to Submit Agreements for Review
     
  4. KUALI Quickguide: Creating & Submitting Initial Proposals
     
  5. KUALI Quickguide: Creating and Submitting Follow-up Proposals