Clinical Study Agreement/Clinical Trial Agreements
(CSA/CTA)

Efficient and timely study start-up requires attention to multiple processes, some of them concurrent, including:

• IRB review and approval (and other committees as applicable, e.g., radiation safety, institutional biosafety, etc.)
• Contract review, negotiation and full execution in Office of Clinical Research (OCR)
• Proper account set up in Financial Services; for any hospital based-charges, set up of clinical system billing number (“98#)

1) IRB review and approval:

Full understanding of the role of the human subjects office and guidance regarding Institutional Review Board (IRB) submission and review is available by visiting the Human Subjects web-site, by calling the office at x 68092 or visiting them in the Office of Research: S1-859

2) The Clinical Study Agreement/Clinical Trial Agreement:

Industry-sponsored clinical trials are highly competitive and time-sensitive.

Choosing the right studies requires a feasibility review, often under a time constraint; efficiency at a research site is important if the investigator is to reach recruitment potential. At the same time, careful review and negotiation of the CSA/CTA is critical. Both University policies and Best Practices in clinical research must be addressed. In order to meet both of these needs (i.e., reasonable turnaround time and careful review), communication between all parties is essential. The following section outlines important issues to keep in mind as you consider conducting an industry-sponsored clinical trial at UMass Worcester and/or at UMass Memorial Medical Center :

Our Philosophy in the OCR:

• Efficient study start-up is a shared responsibility among Office of Clinical Research, sponsor,   investigator and research staff 
• Good communication is crucial: a brief meeting at time of receipt of budget and contract with PI or designee can pave the way to smooth initiation and identify potential issues that need special attention
• Each sponsor and CSA/CTA is treated as a long-term relationship

Important Info about the CSA/CTA:

• All CSA/CTA’s (including their budgets*) are reviewed, negotiated and signed by the Office of Clinical Research.

• A feasibility review for a potential study is the most important first step before moving ahead with a sponsor; be realistic regarding needed timeframe, recruitment plan, staff, space and resources required ( Critical Steps for Clinical Trial Processes  ); consultation re: feasibility is available with Sheila Noone (x65015).

• If interested in an industry-sponsored clinical study, bring contract and budget to OCR (S1-859) so that it is entered into our database or have it sent electronically to:
  • Sheila.noone@umassmed.edu

Receipt will be acknowledged by email with an expected timeframe for completion of review

• A CSA/CTA is between the Sponsor and the University, not with the individual investigator

• If contract requires input and advice from either UMW’s   Office of the General Counsel or Office of Technology Management (OTM), the Investigator will be notified of that layer of review

• The process of contract/budget review, IRB review or other review committee work should happen concurrently, as each piece of the process can take a number of weeks

• Updates on contract review progress (or snafus) will be shared with Investigator regularly, but please feel free to call for an update

• PLEASE REMEMBER: Investigators should not sign any CTA   or budget until the document has been reviewed in the OCR

*Some guidance on budget review with the CSA/CTA

• All budgets are negotiable and an ‘offer’ from industry should be fairly evaluated and any requested increase justified; if not negotiated well, the investigator and institution lose money on a trial
• Final budget is a fixed price agreement – you are obligated to perform the work as described in the contract
• Remember the hidden costs of clinical studies & trials that are not always captured in the neatly packaged unit cost spreadsheet: IRB communications, adverse event reporting, upfront time to assess protocol and feasibility, time away at an investigator meeting, monitor visits, record storage costs, etc
• Underestimating research coordinator time is a frequently seen  problem with budgets we review in OCR – base salary is underestimated, and the hours required to not only conduct a given visit - but plan, remind, document and follow-up each visit - are often not captured
• Budgets can be broken into sections: Institutional Start-up Costs, Investigator Start-up Costs and Per-Subject Costs. Use a   worksheet  to take the budget apart and assess whether what you are offered is reasonable. It will help you easily justify to the sponsor any requested increase (link to my budget worksheet as an example)
• Meet with OCR early on to work through your budget – although the investigator and his/her staff are in the best place to evaluate per-subject costs, the OCR assesses institutional costs and has final budget approval

3) Account Set-up:

• The   Clinical Research Transmittal Form is the critical link between final contract/budget and account setup; this Transmittal Form must be received in OCR by the time the final contract/budget is being prepared. Because both the contract/budget and Transmittal require signatures, please return it with investigator-signed CTA.
• Upon full execution of the contract (all parties have signed) school Financial Services receives information from Office of Research to set up school account into which sponsor checks will be deposited. Financial services sends this account number to Office of Research, Investigator and Dept. Administrator
• If labs, procedures, etc. are being billed through the hospital system, a Clinical Research Billing Number (aka “98 #”) must be assigned. This number is generated by a   Special Accounts Authorization Form ; return this completed form with Transmittal – once the school account number is assigned, the OCR will add that number to this form and fax to UMass Memorial Billing Dept. for assignment of 98 number. This number will be sent to study coordinator and investigator within 2-3 working days.
• Use “98 #” on any research-related requisitions (procedures, lab tests) so that no industry-sponsored research procedures are inadvertently charged to the research subject or his/her insurance.

REMEMBER: Three things must occur before you can recruit into your clinical study/trial: