UTHealth教职员工撰写的临床方案，但由行业赞助商资助。

If a Sponsor is making a direct payment of private funds for the purpose of a specific research project that is PI-initiated - regardless of whether the Sponsor calls it a grant, a contract, or anything else - you’re in the right place.

PROCESS

• The Investigator and the Sponsor agree on a Scope of Work
• A Budget is crafted to cover all costs of the Scope of Work

INTERNAL DOCUMENTATION REQUIRED

• 工作范围/协议范围
• R＆A包
• RCOI表格
• IRB Approval, if applicable
• 其他保证（如果适用）
• 覆盖分析, if applicable (This will need to be determined by SPA’s CRF Team)

Negotiations on the Agreement cannot begin until these documents are submitted. The information provided in these documents will dictate what terms are needed in the Agreement, assist our office in negotiations with the Sponsor, and assure that all potential compliance and conflict of interest issues are identified and addressed.

DEPARTMENT TASKS/RESPONSIBILITIES

• Submit contract to SPA, if provided by Sponsor. Otherwise, SPA will draft it
• Submit Scope of Work
• Submit Protocol to the IRB
• 与赞助商谈判预算(发送的一个副本final Budget to SPA)
• 完全的覆盖分析form initiated by SPA- Submit to SPA
• 填写R＆A表格 - 提交给水疗中心
• 填写RCOI表格 - 提交给水疗中心
• 路由最终（协商）b进行PI签名 - 提交SPA

Note: It is expected that UTHealth’s full indirect cost rate is reflected in the Budget. Any reduction or waiver of indirect costs is considered to be cost sharing and must receive the appropriate prior approval.

SPA TASKS/RESPONSIBILITIES

• Negotiate the legal terms of the agreement with Sponsor on behalf of the PI and the University.
• 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。
• Route the final agreement with the PI’s signature for the University’s Authorized Official to sign
• Contact Post Award to set up a financial account for the study. Once a copy of the fully executed agreement becomes available, and the department has submitted all of the internal documentation, Pre Award will contact Post Award Finance to set up a financial account for the study.