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主协议 |
研究启动协议/ SSUA |
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得克萨斯大学系统及其成员机构已与许多研究赞助商谈判了主协议。beplay苹果手机能用吗主协议简化了合同谈判流程，因为合同条款已由赞助商和大学达成协议。 |
当临床赞助商或临床研究组织（CRO）希望通过提供启动资金来协助PI及其研究团队时，在临床试验协议进行临床试验协议时，通常使用研究启动协议（SSUA）（SSUA）。beplay苹果手机能用吗研究启动协议提供了资金，以帮助PI获得与IRB提交相关的成本和/或支付研究人员的薪水/边缘。beplay苹果手机能用吗 |
| 过程 |
When SPA receives a clinical agreement from an industry sponsor, SPA will determine whether a master agreement exists for that sponsor. If a master agreement does exist, SPA will ask the CRO or sponsor to use the master agreement. SPA will negotiate the legal terms and conditions of the agreement with the sponsor. |
如果行业赞助商与UTHealth医师/PI联系以参与研究，则PI和部门管理员应进行可行性评估，以确定参加临床研究是否在经济上和操作上是可行的。
If it has been determined that the PI/Department would like to participate, the PI or designee should submit the study start-up contract to SPA to negotiate the legal terms of the agreement.
加快启动时间,研究团队的商店uld 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. Agreements with active IRB submissions and Budget negotiations are prioritized. |
| 部门任务/责任 |
- 向IRB提交协议（如果您使用的是带有个人标识符的临床数据）
- 填写R＆A表格，RCOI表格，预算提案草案 - 与ICF和协议草案一起提交水疗中心 -click here
- 与赞助商协商预算
- 在谈判期间，在CC上包括水疗临床试验管理员，这些管理员将提供状态更新（还需要Spa具有最终预算的副本）。
- Complete Coverage Analysis documentation
- 路由PI签名的最终协议 - 提交SPA
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- Conduct a Feasibility assessment
- 将学习启动合同提交给水疗中心CRF@uth.tmc.edu
- 包括：
- 协议草案
- 协议
- Draft ICF
- 预算提案草案
- Submit protocol to IRB
- 与赞助商协商预算
- Include SPA Clinical Trial Administrator on the cc during the negotiations which will provide status updates (SPA is also required to have a copy of the final budget)
- CompleteCoverage Analysis文档 - 在完全执行SSUA之前，不需要批准覆盖范围分析。
- 路由PI签名的最终协议 - 提交SPA
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| SPA Tasks/Responsibilities |
- Negotiate legal terms of the agreement with collaborator on behalf of the PI and the university.
- Obtain PI Read and Understood approval (either signature or electronic approval)
- Route the final agreement with PI signature, if applicable, for institutional signatory to sign
- 水疗中心将发送给合作者以进行完整执行
- SPA will assure PI has a copy of fully executed agreement and will retain a copy for institutional record.
- Initiate process with Post Award Finance to set up a financial account.
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- Negotiate legal terms of the agreement with sponsor on behalf of the PI and the university.
- Build out the coverage analysis shell for the study team to enter in costs, effort, and coverage information. Coverage analysis approval is not needed in order to fully execute a SSUA.
- Route the final agreement with PI signature for institutional signatory to sign.
- 在收到以下项目之前，不能提交机构签名：
- 与PI签名的最终协议
- 最终启动预算的副本
- Initiate process with post award to set up a financial account for the study
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