Clinical Trials Administrative Start-Up Handbook

SECTION 3

OFFICE OF SPONSORED PROGRAMS

Flow Chart Illustrating the Office of Sponsored Programs Process

TABLE OF CONTENTS The Research Agreement The Concurrent Review Process What it is How it works - At CRBB - At OSP Best Practices For Using the Concurrent Review Process For Streamlining the OSP Review Process For Completing the eGC-1 Form for Industry-Sponsored Clinical Trials Significant Financial Interest Disclosure The Budget Number Advance Budget Numbers Key OSP Contacts Timeline

The Research Agreement

For each UW clinical trial, a research agreement is negotiated and executed between the UW and the sponsor, or by a Contract Research Organization (CRO) representing the sponsor. The Office of Sponsored Programs (OSP) is the only UW office authorized to negotiate and sign research agreements. The principal investigator may also be asked to sign the agreement, indicating that he/she has read and understood its terms.

The research agreement defines the legal relationship between the parties and specifies each side's rights and responsibilities with respect to the study. The agreement deals with important issues such as conduct of the study, publication, indemnification, confidentiality, and data ownership. Sponsors ordinarily prefer to use their own standard agreements to provide homogeneity for multi-site studies. If the company's standard agreement language is not acceptable to the UW, then the clinical trial group at the Office of Sponsored Programs will contact the sponsor's representatives to negotiate changes in the language prior to final signature.

The research agreement also includes the financial terms (budget and payment schedule) by which the sponsor will pay the UW for conducting the trial. At the UW, the study team works with the Clinical Research Budget and Billing (CRBB) office to develop and negotiate the study budget and payment schedule. Once developed, the financial terms can then be finalized with the sponsor, either by CRBB or by the investigator. These negotiated financial terms will be included in the research agreement that is signed by OSP.

The Concurrent Review Process

What it is:

In order to reduce the start-up time for industry-sponsored clinical trials, the University has implemented a process by which the contract language and the financial terms are negotiated concurrently. Concurrent processing allows OSP to negotiate the terms and conditions of the research agreement while CRBB negotiates the budget and payment schedule. Combining the budget and agreement negotiations reduces start-up time by several weeks. Other reviews - including IRB review and administrative reviews specific to individual departments - may occur during this time, thus increasing efficiency even further.

How it works:

At CRBB:

• After you have done a feasibility determination, submit the required information to CRBB so that CRBB can begin work on your study. CRBB requires the following information:

• The study protocol
• The sponsor's proposed research agreement
• The sponsor's proposed budget
• The sponsor's proposed consent form
  
  
• At CRBB, the budget package is assigned to a budget specialist who will be in charge of developing and negotiating your budget with the sponsor. Upon assignment, the budget specialist will send you an "assignment message," which you will need to include in your initial eGC-1 package to OSP (see below, "The Concurrent Review Process and OSP"), enabling negotiations to begin at OSP while the budget is being developed at CRBB.
  
  
• The CRBB budget specialist will keep in touch with you while your budget is under development and will send you a "review summary" email when the budget is complete. The review summary will also be sent to your department administrator for his/her authorization. Watch for possible or actual budget deficits. If these occur, you and your department administrator will need to discuss plans for handling the deficits. By their authorizations, the Dean's Office and all other concerned parties will assume that the department administrators are aware of and have plans for handling any budget deficits incurred by the study.
  
  
• When you receive the "review summary" email from CRBB, withdraw the eGC-1 form in SAGE, insert the budget information, attach the review summary, and re-submit the eGC-1 form. This step does not require a second round of signatures.

At OSP:

• After you have done a feasibility determination, complete an initial "eGC-1 package" and route the package for division/department signatures to OSP. For School of Medicine industry-sponsored clinical trials, the initial eGC-1 package is composed of:
  
  • The completed eGC-1 Form . In the budget section on page 1 of the eGC-1 form, enter "$0" by Total Direct Costs and "$0" by Total Costs.
  • The sponsor's proposed contract
  • The "assignment message" from the Clinical Research Budget and Billing office
  • The study protocol
  • The completed Significant Financial Interest Disclosure Form (if required)
    

All of these items will be routed electronically. By their signatures on the eGC-1 form, the department chairs and division heads signify that they are aware of and approve our plans to perform the trial, pending receipt of final budget negotiation information in CRBB's "review summary" email.

• At OSP, the eGC-1 package is assigned to a contract administrator in the clinical trials group who will be in charge of negotiating your agreement with the sponsor. Upon assignment, the administrator will identify himself/herself to you by email message and will continue to update you by email throughout the research agreement negotiations. OSP will assume that you are working with CRBB to develop the study budget and payment schedule, and OSP will confine its negotiations with the sponsor to the agreement's other terms and conditions.
  
  
• When you receive the "review summary" email from CRBB, withdraw the eGC-1 form in SAGE, insert the budget information, attach the review summary, and re-submit the eGC-1 form. This step does not require a second round of signatures.
  
  
• When OSP has received the final eGC-1 form (the one with the budget information), the clinical trials group will proceed to finalize the research agreement. In order to finalize the agreement, OSP will need a copy of the IRB-approved consent form and, if applicable, a Significant Financial Interest management letter. After the agreement has been signed, OSP will follow your instructions by mailing the signed research agreement directly to the sponsor.

Best Practices

For using the concurrent review process

In general, for the concurrent review process to work, the best advice is this:

• Work closely with OSP and CRBB by providing timely information to both offices. Neither CRBB nor OSP will be able to start work on your study until they have received all of the required materials.

For streamlining the OSP review process

• Ask OSP whether the UW has negotiated a Master Agreement with your trial's industry sponsor. If no Master Agreement exists, OSP will typically use the sponsor's proposed single-trial contract when negotiating terms and conditions on your behalf. You can help OSP by recording your own comments about the contract language, either on a separate page or in the margins of the contract itself. Send your comments to OSP. Do not send these comments to the sponsor - doing so would confuse the negotiations.
  
  
• Note that for industry-sponsored clinical trials, the Department of Medicine requires signature by both the Principal Investigator's Department Chair and Division Head.  By their signatures on the final eGC-1 form (the one with the budget information), department chairs and division heads signify that they are aware of and have plans for handling any budget surpluses or budget deficits incurred by the study.
  
  
• Ask OSP to arrange for an advance budget number for your research project.
  
  
• Provide OSP with your budget number or the sponsor's overnight delivery account.

 

For completing the eGC-1 form for industry-sponsored clinical trials

• Certain sections of the eGC-1 Form might cause confusion for investigators who are completing the form for industry-sponsored clinical trials. For point-by-point instructions about completing these sections, see Completing the eGC-1 Form for Industry-Sponsored Clinical Trials. . Please call the clinical trials group at OSP (206-543-4043) or your departmental grants administrator if you have additional questions about the eGC-1 form.

Significant Financial Interest Disclosure

For industry-sponsored clinical trials, the UW SOM has adopted a "zero disclosure threshold" for financial interest reporting. This means that any interest, regardless of financial value, held by the principal investigator, co-principal investigators, or any person who is responsible for the design, conduct, or reporting of the research must be reported by means of the Significant Financial Interest Disclosure Form. The purpose of the Form is to determine whether there is potential for financial conflict of interest and, if so, to manage or eliminate it.

To determine whether you need to complete the Disclosure Form for a particular clinical trial, refer to GIM 10, the UW "Investigator Significant Financial Interest Disclosure Policy for Sponsored Projects." If a disclosure is necessary, follow the instructions outlined in GIM 10 by attaching the completed Disclosure Form and supporting documentation to the eGC-1 package. Route the package through the normal signature process.

OSP will not sign an agreement until the significant financial disclosure has been reviewed favorably.

The Budget Number

You'll need a budget number in order to use your study account. Budget numbers are assigned by Grant and Contract Accounting (GCA), upon authorization from the Office of Sponsored Programs (OSP).

OSP will *authorize your budget and notify GCA to set up your study account. In order for this to happen, OSP requires:

• A clinical trial agreement or an award from a non-industry fundor, signed by the UW
• An approved IRB application
• A favorably reviewed Significant Financial Interest Disclosure (if applicable)

*Note that OSP and GCA do not require a check from the sponsor before authorizing and setting up your account if your study is an industry-sponsored clinical trial at 25% IDC.

GCA will notify you of the assigned budget number, which you can then report to CRBB, enabling CRBB to activate your account. You are then free to begin using the account.

For industry-sponsored clinical trials, instruct the sponsor to send checks to you, to your department, or directly to GCA. For non-industry-sponsored clinical studies, instruct the sponsor to send checks directly to the OSP. Emphasize to the sponsor that all checks should be labeled with the investigator's name and the study title. If unlabeled checks are sent to GCA or OSP, time will be lost while staff at either office try to match the check with the study. The checks should be written to the "University of Washington."

Checks sent directly to GCA should be mailed to:

University of Washington Grant and Contract Accounting
3917 University Way NE - Room 150
Seattle, WA 98105-1122

Checks sent directly to OSP should be mailed to:

University of Washington Office of Sponsored Programs
4333 Brooklyn Avenue NE - 17th Floor
Seattle, WA 98195

Advance Budget Numbers

If you want to receive your budget number before the clinical trial agreement has been signed or before the official notice of award, you may request an "advance" budget number. Advance budget numbers are convenient when, for example, you need to complete pre-trial activities in preparation for a fast start-up after the agreement has been signed. To request an advance budget number:

• Enter SAGE. At the top of the page, select the "My Advance Requests" tab.
  
• Determine whether your study is eligible for an advance budget number by taking the tutorial entitled "How to Create the Online Advance Budget Request Form."
  
• If your study is eligible for an advance budget number, go to the "Create New" tab (again, at the top of the page) and, to access the form itself, select "Advance Request."
  
• Remember to follow the step-by-step instructions in the tutorial. When your advance budget number has been authorized, GCA will send you an email message notifying you of the assigned budget number, which you can then report to CRBB to activate your account.

Note these important points when considering an advance budget number:

• Although an advance budget number enables you to complete requisition forms and to charge the study account, if the sponsor's check(s) do not arrive, your department is responsible for covering all advance expenditures.
  
• You may not contact or enroll study participants until the research contract has been signed both by the UW and by the sponsor and until the IRB has approved your study.

Key Contacts

The clinical trials group:

Office of Sponsored Programs
Box 359472
Main telephone number: (206) 543-4043
FAX: (206) 685-1732
Street address: 4333 Brooklyn Ave. NE - 17th Floor, Seattle, WA 98195-9472
Web address: http://www.washington.edu/research/osp/

 

Timeline

At OSP, eGC-1 packages are assigned to contract administrators as they are received. Allow up to 45 days for OSP to negotiate and sign the agreement. Usually, OSP is able to handle the agreements more quickly, but this depends upon a number of factors including the acceptability of the sponsor's proposed agreement and the sponsor's speed in responding to the UW's questions.

Submit concurrently to CRBB and OSP. Concurrent submission to other start-up oversight offices (such as for IRB review) will allow even further efficiency. If start-up reviews are done consecutively instead of concurrently, lengthy delays can result.