clinical research account set-up/business practices

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Clinical Research Account Set-Up/Business Practices

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Page 1: Clinical Research Account Set-Up/Business Practices

Clinical Research

Account Set-Up/Business Practices

Page 2: Clinical Research Account Set-Up/Business Practices

Applicable TTUHSC OPs • HSC OP 10.16: Compliance • HSC OP 50.03: Account Manager Designation and Signature Authority• HSC OP 50.07: Proper Handling of Cash Collections• HSC OP 50.08: Secondary Depository Procedures• HSC OP 50.09: Deposit of Private Gifts, Grants, and Agreements• HSC OP 50.21: Change Funds and Petty Cash Funds• HSC OP 50.34: Residual Funds Derived from Drug Studies, Clinical

Trials, Fixed-Price Contracts and Investigator-Initiated Research

• HSC OP 50.35: Unidentified Receipts and Holding Account Maintenance

• HSC OP 65.01: Establishing Sponsored Program Accounts/Budgets• HSC OP 65.02: Facilities and Administrative Cost Recovery Plan• HSC OP 65.06: Contracts and Grants Made Directly to Individuals

Page 3: Clinical Research Account Set-Up/Business Practices

New Study Accounts Summary

• Occurs upon receiving first check

• Checks (from the sponsor) should be mailed directly to the Division of Clinical Research (Pam Frazier). The liaison (Dawn Bender) will then notify you with information and request documentation.

• If you are at a regional campus and the sponsor incorrectly sends the check to you, the check should be deposited immediately into a holding account. The Financial Monitor (Jill Raupe) should then be notified. If you are at the Lubbock campus please send the check to the Division of Clinical Research (Pam Frazier).

• You will then complete these forms:-Account History Form-Signature Authority Form (HSC OP 50.03)

-Budget Revision Form

• Copy ALL of these forms for your records and send originals to Financial Monitor (Jill Raupe), mail stop 8146

• Account number assigned by Accounting Services (Kathleen Emmons)

Page 4: Clinical Research Account Set-Up/Business Practices

Locating Forms Online

• Budget Revision Form

• History File Form

• Signature Authority Form

Forms may be saved to your hard drive for quicker

and easier access for future use.

http://www.fiscal.ttuhsc.edu/accounting/forms/

Page 5: Clinical Research Account Set-Up/Business Practices
Page 6: Clinical Research Account Set-Up/Business Practices

The Budget Revision Form

• Revenue– Code 48: Investigator payments

• Expense– Code 55: F & A (indirect costs)

• Formula: Total amount divided by 1.25 X .25 = indirect rate

• Other expense codes– Code 02: Other salaries– Code 07: Fringe Benefits– Code 10: Maintenance and Operation– Code 23: Subject Costs

Page 7: Clinical Research Account Set-Up/Business Practices
Page 8: Clinical Research Account Set-Up/Business Practices
Page 9: Clinical Research Account Set-Up/Business Practices

Established Study Accounts Summary

• Checks (from the sponsor) should be mailed directly to the Division of Clinical Research (Pam Frazier). The liaison (Dawn Bender) will then notify you with information and request documentation.

• If you are at a regional campus and the sponsor incorrectly sends the check to you, the check should be deposited immediately into a holding account. The Financial Monitor (Jill Raupe) should then be notified. If you are at the Lubbock campus please send the check to the Division of Clinical Research (Pam Frazier).

• You will then complete this form:– Budget Revision Form

• Copy form for your records and send originals to Jill Raupe, mail stop 8146 or [email protected]

– Both electronic and paper copy allowed

• Accounting Services (Kathleen Emmons) processes Budget Revision Form

Page 10: Clinical Research Account Set-Up/Business Practices
Page 11: Clinical Research Account Set-Up/Business Practices

Closing a Study Account

• Final payment received, deposited, and budgeted

• Check study files to determine if all payments have been made

• Check contract and/or sponsor to determine if TTUHSC may keep remaining funds

• Complete Budget Revision form and submit to Financial Monitor (Jill Raupe)– Code 94: Non Mandatory Transfer OUT of study account– Code 98: Non Mandatory Transfers INTO residual account

• Accounting Services (Kathleen Emmons) will then perform a final check of indirect costs and close account; rolling money into residual account (HSC OP 50.34)

Page 12: Clinical Research Account Set-Up/Business Practices

Fee Invoicing

• Division of Clinical Research

– Will invoice for administrative and pharmacy fees for clinical trials (all campuses)

• Research Integrity Office

– Will invoice for IRB fees for clinical trials

(all campuses)

Page 13: Clinical Research Account Set-Up/Business Practices

Contact Information

• Liaison: Dawn Bender– 743-2556– [email protected]

• Financial Monitor: Jill Raupe– 743-4754– [email protected]

• Director of Contracting: Pam Frazier– 743-4367– [email protected]

• Accountant: Kathleen Emmons– 743-1888 x 267– [email protected]