Effective July 1^st, 2019 

• Administrative Start up fees will be invoiced centrally for 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 fees will be automatically debited from study project FMS account 120 days after invoice has been sent to the sponsor.

• SPA will provide assistance to departments experiencing payment issues. Please contact SPA with any payments >120 days past due to request assistance with collection activities.

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.
• Each Clinical Trial Agreement will generate an IRB fee invoice and an Administrative Startup invoice. It is the department’s responsibility to provide SPA with the names of the financial staff whom they would like to be included on the cc when the invoices are sent to sponsor. The most efficient approach would be to simply include applicable financial staff on cc upon initial submission of the contract to SPA.
• See attached Frequently Asked Questions sheet

Process:  Flow chart Click Here 

Frequently Asked Questions:

1. If I forget to include start up fees in the contract, will they be invoiced anyway?

Answer:

No, we will not invoice for these services if they are not clearly defined in the contract.  It is the department’s responsibility to assess the costs to conduct the study and to ensure these costs are covered in the contracted budget. If you find that some of your costs are not covered, immediately contact the sponsor and request a contract amendment to amend the budget.

2. Does CPHS include the IRB fees and the startup fees in one invoice?

Answer:

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

3. After the invoices for IRB fees and Startup fees have been sent to Sponsor, how long should I wait to follow up with sponsor?

Answer:

Typically departments follow up monthly on invoices. However, each department has their own processes for follow up. Please check with your DMO or direct supervisor to learn departmental procedures. Payments usually arrive within 30-45 days from receipt of invoice.

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

Answer: Any tasks performed to prepare/make ready for conducting the study at UTHealth as outlined in the contract/budget.

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
• Radiology Start up fees
• Note in some contracts various administrative start up items are listed out separately rather than included in one ‘Administrative startup fee’

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

Answer:  Send an email to 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?
   • Example contract lists out all of the below items in the “One time Invoiceable” section of the contract
     • Administrative Startup fee          $6000.00
     • IRB submission preparation fee  $1000.00
     • Attend investigator meeting fee  $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. I understand the IRB fee will be debited from the 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: 

Yes, although this is an unlikely scenario, the account associated with the study will be debited 120 days after the invoice was sent to sponsor. If there are not funds in the account, this will cause a negative balance.  Sponsors normally pay for services provided, however if a case arises in which you have not received payment for an invoice, please contact SPA. SPA/ CRF will help you to communicate with sponsor to uncover what underlying issues are causing the delayed payment(s). Contact SPA/CRF Team at 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.

(The “PAF Notification for Account Setup” email chain is 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.