行业临床研究预算

临床试验协议(cta)vern the terms of research between the Universities and set the expectations and responsibilities of the parties. Industry initiated clinical trials are executed for trials following a sponsor- or investigator-initiated protocol.

通常，CTA由制药和医疗设备公司资助，是食品药品监督管理局（FDA）批准过程的重要组成部分。来自CTA的数据有助于确保将被带入市场的药物或设备的安全性和功效。

Because most industry initiated clinical trials are fixed price awards, the University will be paid for services rendered, regardless of how much of the funds are expensed. The terms of the contract allow for the residual balances in these accounts to vest with the University. In order to properly account for expenditures associated with the clinical trial, the FMS account associated with a clinical study must be closed out once the research is complete at the University.

PROCESS

Clinical Trial Account Closeout begins once the IRB Closeout Report has been submitted in iRIS. Each month the CRFA team reviews the submitted closeout reports in iRIS for funded studies. If a funded study has been closed, the FMS account is updated to reflect the date that the study ended at the University. CRFA then changes the active dates on the account to allow the study team one year to receive final payment from the sponsor and to pay any outstanding invoices which may still be pending.

在大学结束后的一年后，CRFA团队将进行完整的帐户分析。该分析将考虑到大学入学的研究科目的数量，从赞助商那里获得的收入，适用于帐户的费用。CRFA团队将注意到帐户上花费的努力以及在研究期间应产生的患者护理费用。如果在项目中提交的内部预算与邮寄到帐户的费用之间存在差异，那么CRFA团队将建议该部门应从其余的剩余余额中恢复过来。

然后将CRFA团队生成的分析和报告提交给管理运营总监或其他部门领导层，并在适当的审查和批准中提交。如果部门领导层批准了建议的分拆，他或她将签署批准，并让首席调查员签署批准。

目前，部门领导可以建议与CRFA团队建议分裂的替代拆分。如果发生这种情况，部门领导将需要为替代分裂提供理由，并获得主席和部门院长的签名。

Once the CRFA team receives the signed approvals they will then perform the necessary journal entries to transfer the residual balance to the appropriate residual accounts for spend down. After the journal entries have been complete, then the department can budget the transferred revenue in the residual account.

DEPARTMENT TASKS/RESPONSIBILITIES

• 提交IRB关闭报告
• Review Account Analysis from CRFA team
• 在临床试验结束摘要和批准表中获得必要的签名。
• Send signed document tocrf@uth.tmc.edu
• 预算转移了剩余帐户中的收入。

水疗任务/职责

• 每月检查虹膜的封闭研究。
• Mark accounts for closeout one year after their date of closure in iRIS.
• 确保没有未偿还的收入或费用在帐户上待定。
• 进行帐户分析并建议剩余收入分配。
• Send completed Clinical Trial Closeout Summary and Approval From for signature to department management.
• 执行必要的日记帐分录以将剩余收入转移到剩余帐户。