LEGAL & FINANCIAL REVIEW

Documents Reviewed

Non-Disclosure Agreements (NDA)

The CTO coordinates review of NDAs by the Office of Innovation & Partnership.

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.

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.