GUIDE TO INDUSTRY SPONSORED CLINICAL TRIAL AGREEMENTS
A clinical trial agreement (CTA) is a contract between the University of Mississippi Medical Center (UMMC) and a sponsor or its designated contract research organization (CRO) to carry out a clinical research study. The Office of Research staff will work with the sponsor, the CRO, the investigator, and the attorneys to negotiate the confidential disclosure agreement (CDA), clinical trial agreement, and the budget. Clinical research involving human subjects requires approval by UMC’s Institutional Review Board (IRB). The CTA cannot be fully executed until IRB approval is obtained.
Confidential Disclosure Agreement (CDA)
The sponsor or CRO will ask the PI to sign a CDA before sending information about the proposed study. Fax or e-mail the agreement to the Office of Research to the attention of Penny Lowery (5-5010), even if only the PI is asked to sign. We will review the agreement, get the approval of the staff attorney, and negotiate any needed modifications prior to signing. If this agreement requires an institutional signature, we will obtain that signature as well.
IRB Approval
Both the IRB approval process and the contract/budget negotiation can be lengthy; therefore, we recommend initiating your IRB submission as early as possible. You will submit the following items to the IRB for review: a cover letter, a completed IRB Evaluation form, the study protocol, the investigator’s brochure, and the informed consent document. Further information on IRB guidelines is available at http://irb.umc.edu/Guidance_Information.html.
Clinical Trial Agreement (CTA) and Budget
While you are preparing the IRB submission for the study, the Office of Research will review the draft CTA and budget provided by the sponsor or CRO. To initiate this process, forward the following documents to Michelle Richard in the Office of Research:
1) UMMC Transmittal Form. Submit with signature of the Principal Investigator and the Department Chair. If the budget has not been negotiated, this section can be left blank. The Transmittal Form and Instructions for completion of the form can be found at http://dor.umc.edu/forms/UMC/index.html
2) Draft agreement and budget (preferably electronic).
3) Copy of the protocol (preferably electronic).
4) Completed Research Plan Code application form if the study requires hospital and/or physician services.
During the contract/agreement and budget negotiations, we will contact the PI and the clinical team to discuss terms, conditions, and budget issues. We will draft a budget with estimated costs for the procedures and activities required by the protocol. Using this as a starting point, we will work with the PI and study team to develop a budget to meet the needs of the study. For hospital and physician services, standard rates will be incorporated into the budget. Procedures for using Clinical Laboratory Services for phlebotomy, specimen processing/shipping, or laboratory analysis are at http://irb.umc.edu/GuidanceInfo/CLINIClabspecguidellines.DOC .
Once the study costs are negotiated with the sponsor, the budget will become the official UMC internal budget used in the payment approval process. The budget attached to the contract may be in a different format with different line items, as specified by the sponsor/CRO, but the total per patient budget will match the internal UMC-approved budget. The internal budget is approved and signed by the Office of Research, the PI, and any clinical research program that is providing services for the study.
The CTA will be reviewed by the Office of Research, the Staff Attorney, and the Office of Compliance. We will alert the PI to any terms or conditions that may require further consideration before negotiating the final contract with the sponsor.
Once the CTA and budget have been negotiated, the final agreement is signed by the PI. Contracts are then sent to the Staff Attorney and the Office of Compliance for approval. The transmittal, research plan code form (if appropriate), and pertinent protocol information is forwarded to Hospital Administration for approval if hospital space or services are involved. CTAs will be held for institutional signature until the study has been approved by the IRB.
Primary Contact during Negotiation:
Michelle Richard 5-5008, mmrichard@dor.umsmed.edu
The complete packet for clinical trials includes the following documents:
1) Completed UMC Transmittal with PI and Department Chair signatures
2) Final Contract and budget with Investigator signature
3) Internal UMC-approved budget with Office of Research, PI and clinical program approvals
3) Research Plan Code application form (if applicable)
4) Copy of the protocol
After the study is approved by the IRB, the institutional representative signs the CTA and the Office of Research forwards the agreement to the sponsor/CRO for signature. A copy of the fully executed contract is forwarded to the PI when returned to UMC. The original contract will reside with the staff attorney, and a copy will be forwarded to Suzy Campbell, Grants Accounting Manager. When the first payment arrives from the sponsor, Grants Accounting will establish the study account.
Invoicing the Sponsor
On some studies, after the contract is fully executed, sponsors or CROs may require that the site submit invoices for services. Review the contract for instructions on submitting invoices. An invoice template is available at http://dor.umc.edu/proposalprep/Contracts.
The IRB will invoice the sponsor/CRO directly for IRB review fees.
Billing the Study Account for Hospital and/or Physician Services
PI is responsible for requesting a UMC Research Plan Code by completing the application form. The Research Plan Code is approved by Hospital Administration and assigned by Patient Financial Services upon execution of the contract and entered into the SMS Invision system prior to study patients receiving hospital services. The Invision Research Plan Code directs the hospital billing system to send invoices to the study coordinator.
•Once the Invision Research Plan Code is established, the PI requests a SMS Signature Research Plan Code if physician services are needed. Requests for Signature Plan Codes should be directed to Tom Skinner at tskinner@clinassoc.umsmed.edu
The Signature Research Plan Code instructs the physician billing office to send the invoices to the study coordinator.
• PI is responsible for ensuring that study patients are registered for each visit where hospital or physician services are required using the Invision and Signature plan codes. The completed Registration form should be presented to Registration staff before a study patient receives a study-related service. If the study patient is enrolled in an inpatient study after admission to the facility, Registration must be contacted and instructed to change the patient’s registration code to the appropriate Invision Research Plan Code.
• The hospital and PLLC’s will invoice for services rendered. The plan codes will instruct the billing offices to send invoices to PI’s study office for review and payment.
• PI confirms visit date/procedures, pays Invoice via a Purchase Requisition. Attach the account summary to the purchase requisition for payment of study-related hospital charges. Attach the CMS 1500 to the purchase requisition for payment of study-related physician charges.
Use the following object codes on the purchase requisition:
• 164 for hospital charges
• 185 for PLLC physician charges
• Grants Accounting forwards purchase requisitions for payment of physician services on industry sponsored clinical trials to the Office of Research for approval. Office of Research approves the requisition after reviewing procedure costs for consistency with budget documentation.
• All physician fees are subject to institutional and departmental assessments.
• For study patients where registration is not required for physician services, the PI should work with the departmental business services manager to develop an invoice for services rendered. A service summary should be attached to the Purchase Requisition that itemizes the services rendered. A template service summary is available on the Office of Research website.
Billing for Coordinator fees
Executing this option requires having a UMC account that can receive funds from other UMC accounts. Contact Susan Campbell in Grants Accounting for more information on these accounts.
• Coordinator fees, start-up and close-out fees, and administrative fees can be invoiced into a UMC research account via an Interdepartmental Invoice with the following object codes:
• 169 for account charged
• 914 for account credited
• Interdepartmental Invoices for coordinator services must detail the services rendered with their associated costs (unit costs and number of units), and the inclusive dates of service.
Account Closure
The PI closes the study account after all invoices are paid and all study requirements are met.
For closeout, provide Grants Accounting with:
1. A copy of the IRB close out letter
2. Documentation from the sponsor that the study is complete
3. A memo from the PI certifying that all financial obligations have been expensed to the study account. Any residual funds remaining in a study account may be transferred to a UMC research account.
NOTES
• Service and procedure costs in the UMC-approved study budget will be consistent with standard hospital and practice plan rates. Payments for physician procedures/services rendered on clinical studies may be less than the standard practice plan rate, but not more. If a negotiated cost is less than the standard practice plan rate, the PI should note the lower rate on the PLLC invoice at time of payment.
• Standard physician services/procedures are the only services billable by practice plans. This does not include generic investigator fees that may appear in the budget associated with the contract.
• PI is responsible for ensuring that other physicians providing services for the clinical study are aware of the billable amount in the UMC-approved study budget and that the appropriate Research Plan Code is used.
• PI is responsible for managing the clinical trial account and ensuring that sufficient funds are available to pay all anticipated expenses.
• Coordinator fees can be invoiced on an Interdepartmental Invoice form and transferred into an internally-designated UMC Research Account. Standard UMC Accounting policies and procedures apply. For further information contact Susan Campbell in Grants Accounting (4-1058).