LEGAL & FINANCIAL REVIEW
Documents Reviewed
Confidential Disclosure or Non-Disclosure Agreements (CDA/NDA)
The CTO reviews and negotiates all CDAs and NDAs for or related to research conducted by LSUHSC faculty. Contracts are negotiated in accordance with University legal policies and procedures.
Clinical Trial Agreements (CTA) & Amendments
The CTO reviews and negotiates all contracts/agreements for or related to industry-supported clinical trials and clinical research. Contracts are negotiated in accordance with University legal policies and procedures.
Data Transfer & Use Agreements (DTUA) & Material Transfer Agreements (MTA)
The CTO reviews and negotiates DTUAs and MTAs for or related to research conducted by LSUHSC faculty. Contracts are negotiated in accordance with University legal policies and procedures.
Medicare Coverage Analysis (MCA)
The CTO utilizes third-party Medicare coverage analysis research solutions for all clinical trials/research. Use of third-party services reduces the possibility of improper billing processes, shortens the time required for coverage analysis and assures the right payer covers costs. The CTO will provided the appropriate documentation needed to complete MCA to third-party services providers via their online portals.
Internal & Sponsor Budgets
The CTO reviews and negotiates all budgets for industry-supported clinical trials and clinical research. Budgets are negotiated in accordance with University financial policies and procedures as well as hospital policies and procedures, as applicable.
LSUHSC's current Facilities and Administrative (F&A) Rates can be found here. Upon receipt of a draft budget a
nd MCA, a member of the CTO will meet/email with the PI and other appropriate study personnel to review the draft documents. If acceptable, the PI will sign off. As changes are made, the PI and appropriate personnel will be consulted and the PI will continue to sign off until a final budget is negotiated.
How to Submit
Please submit all applicable documents related to the Clinical Trial to the CTO via the Kuali Negotiations Module. Make sure to note if the clinical trial/research will take place at a hospital.
The following documents must be provided to the CTO before negotiations can begin:
- Protocol
- Draft Informed Consent
- Sponsor's budget (if available)
- Draft internal Budget
- Draft contract/agreement
- IRB or IBC # (if available)
The CTO will handle negotiations directly with the Sponsor and any third parties involved (i.e., hospitals).
Upon completion of the negotiations, CTO will route the final contract/agreement, budget, MCA, and any other relevant documents to LSUHSC and the hospital, if applicable, for the appropriate signatures. The Sponsor will receive a partially executed copy for them to execute.
Resources
Clinical Trial Agreement Template
Clinical Trial Amendment Template
Data Use and Transfer Agreement Template (HIPAA)
Data Use and Transfer Agreement Template (Common Rule)
Kuali QuickGuide: Submitting Contracts and Agreements for Review (PDF)
Kuali QuickGuide: Submitting Contracts and Agreements for Review (Video)
LSUHSC In-House Budget Worksheet
Negotiations and Routing Workflow
Routing Contracts & Budgets for Review, Negotiation, & Execution
Routing Contracts & Budgets for Review, Negotiation, & Execution - Stanley S. Scott Cancer Center
UMC Clinical Trials Approval Process