A Clinical Trial Agreement (CTA) is an agreement between UTHealth and an Industry sponsor (typically a pharmaceutical or device company) to conduct a clinical study in which the protocol is书面并提供by the industry sponsor.

*注意：如果该协议是关于Uthealth教师编写的协议，或者是作为Uthealth教职员工与行业赞助商之间的合作而写的Sponsored Research Agreementis required. See临床试验开始for more information.

PROCESS

If an UTHealth physician/PI is approached by an industry sponsor to participate in a study, the PI and department administrator should perform a feasibility assessment to determine if it is financially and operationally feasible to participate in the clinical study.

如果已经确定,π/部门would like to participate, the PI or designee should submit the contract to negotiate the legal terms of the agreement.

To expedite start up timelines, the study team should negotiate the study budget with sponsor and submit the protocol to the IRB at the same time SPA is negotiating the legal terms of the contract.注意：优先考虑与主动IRB提交和主动预算谈判的协议。

行业赞助的研究过程清单[View PDF]

DEPARTMENT TASKS/RESPONSIBILITIES

• 进行可行性评估
• Submit Contract to SPA atcrf@uth.tmc.edu. Include a copy of:
  • Draft agreement
  • Protocol
  • ICF草案
  • Draft Budget Proposal
• 将协议提交给IRB
• Negotiate budget with sponsor
  • 在谈判期间包括CC上的水疗临床试验管理员。预算状态将表示部门优先级状态
• Complete Coverage Analysis (CA) documentation:
  • Complete all tabs within UTHealth Coverage analysis (CA) excel form
  • PI标志“计费证明”表格（通过签署PI确认CA是准确的，并确保对本研究的研究计费过程进行监督。）beplay苹果手机能用吗
  • PI填写并标志“合格审判评估”表格
• Complete theR&A表格 - 提交水疗中心
  • 需要PI和椅子/DMO签名
• 填写利益冲突表格RCOIform for each member of the study team- submit signed form to SPA
• Route the final agreement for PI signature - submit to SPA

SPA TASKS/RESPONSIBILITIES

• 代表PI和大学与赞助商协商该协议的法律条款。
• 为研究团队提供覆盖范围分析外壳，以输入成本，精力和覆盖范围信息。
• 将与PI签名的最终协议路由机构签署者进行签名。
• Contract will not be submitted for institutional signature until the below items are received:
  • Final Agreement with PI signature.
  • Copy of Final budget.
  • Copy of IRB approval.
  • Coverage analysis documentation received and approved by SPA-CRF team.
  • R&A form signed by PI and Chair/DMO.
  • RCOIform signed for everyone listed as members of the study team on the R&A form.
• Initiate process with post award to set up a financial account for the study.
• 邮政财务团队通过电子邮件发送奖励设置通知。