自7月1日生效^st, 2019

• 行政启动费将是invoiced centrallyfor all industry initiated clinical studies. (Flow chart)
• The IRB will no longer perform collection activities for unpaid invoices.CPHS will continue to invoice sponsor directly for IRB fees, however, CPHS will no longer be responsible for following up with sponsors if payment is not received.
• The departments are responsible for monitoring applicable financial project accounts for payment receipt and for performing collection activities if necessary.
• IRB费用将在发送发票后120天从研究项目FMS帐户中自动借记。

• 水疗中心将为经历付款问题的部门提供帮助。请与Spa联系以> 120天> 120天的任何付款，因为请求协助在收款活动中.

Administrative Startup fee Central Invoicing Notes:

• The PI and/or Department is responsible for ensuring terms related to administrative startup costs are clearly incorporated within the Clinical Trial Agreement as well as the budget. Note: If the administrative start up fees are not clearly defined within the contract they cannot be invoiced.
• 每项临床试验协议将产生IRB费用发票和行政启动发票。该部门有责任向Spa提供财务人员的姓名，他们希望将发票发送给发票时将其纳入CC。最有效的方法是简单地将合同最初提交给水疗中心的CC中的适用财务人员包括在内。
• See attached Frequently Asked Questions sheet

过程:流chart点击这里

Frequently Asked Questions:

1. 如果我忘记将启动费用包括在合同中，无论如何它们会被开票吗？

Answer:

不，如果合同中未明确定义这些服务，我们将不会为这些服务发票。评估进行研究的费用并确保这些费用在合同预算中涵盖的成本是该部门的责任。如果您发现您的某些费用不包括在内，请立即与赞助商联系，并要求进行合同修改以修改预算。

2. CPH是否将IRB费用和启动费用包含在一张发票中？

Answer:

No, CPHS will send two invoices within one email. One invoice for the IRB fees and one invoice for the startup fees.

3. 在将IRB费用和启动费的发票发送给赞助商之后，我应该等多长时间跟进赞助商？

Answer:

通常，部门每月在发票上进行跟进。但是，每个部门都有自己的程序进行跟进。请与您的DMO或直接主管联系以学习部门程序。付款通常在收到发票后30-45天内到达。

4. What items are included in the “Administrative Startup Fee” invoice?

Answer:按照合同/预算中概述的概述，为在UTHealth进行准备/准备进行研究的任何任务。

Some examples of items that would be included are:

• Administrative Startup fees
  • This is a fee charged to cover administrative preparation to conduct the study. This fees covers time and effort expended on items such as (but not limited to) reviewing the protocol, completing feasibly assessment, negotiating contract and budget, completing coverage analysis, completing all regulatory documents, completing IRB submission forms, attending investigator meetings, creating source documents, in-service training sessions, etc.
• Investigational Drug Pharmacy set up/start up fees:
• Clinical Research Unit set up/start up fees
• 放射学启动费
• 注意在某些合同中，各种行政启动项目被单独列出，而不是包含在一个“行政启动费”中

5. How should I contact someone if I have questions or concerns about the IRB and/or start up invoice?

Answer:发送电子邮件至centralinvoicing@Uth.tmc.edu.

6. Will record archiving and storage fees be included in the “Administrative Startup Fee” invoice?

Answer:

Yes, it is best practice to collect these fees upfront. You may forget to invoice for these services later.

7. Contracts vary in the way they are written. In some contracts all of the administrative start up activities may be listed out separately, but in other contracts they may be combined together in one sum. How will the central office note this on the invoice?
   • 示例合同列出了合同的“一次不可传输”部分中的所有以下项目
     • Administrative Startup fee $6000.00
     • IRB submission preparation fee $1000.00
     • 参加调查员会议费$ 2000.00
     • EDC Training activities fee $1000.00
     • IDS Pharmacy set up fee $2000.00
     • Archiving and Storage fee $1500.00

Answer:

All of the above will be listed as separate lined items within the Administrate Start up Invoice. Each lined item will be added together to create a grand total.

8. 我理解的IRB费用将记入借方project account 120 days after invoice is sent to sponsor. If there are not enough funds in the account to cover the IRB fee, will this create a negative balance?

Answer:

是的，尽管这是一个不太可能的情况，但与研究相关的帐户将在发票发送给赞助商后120天借记。如果帐户中没有资金，这将导致负余额。赞助商通常为提供的服务付费，但是，如果您尚未收到发票付款的案件，请联系Spa。SPA/ CRF将帮助您与赞助商进行交流，以发现什么根本问题导致付款延迟。联系SPA/CRF团队crf@uth.tmc.edu

9. How do I make sure the person responsible for financial aspects of this study is included on the cc when the startup invoice is sent to sponsor?

Answer:

All department personnel listed on the cc within the “PAF Notification for Account Setup” email chain will be included on the cc when the IRB &Start up invoices are sent to sponsor. You should let your SPA Contract Analyst know the name(s) of the person (s) to be included on the cc in the “PAF Notification for Account Setup” email string.

（这“PAF Notification for Account Setup” email chainis in reference to the email sting in which SPA/ Preaward sends the contract and all associated documents to SPA/Post Award Finance (PAF) via email and requests a new account set up. PAF builds the study- specific financial account in UTHealth’s financial management system (PeopleSoft FMS) and replies with the new account number.