Page 494 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: F014 SOP Title: Research Study Close-Out
1. PURPOSE & INTRODUCTION
The purpose of this standard operating procedure (SOP) is to outline the process of ensuring all study charges have been appropriately captured and invoiced upon receiving notification of study closure in the IRB.
2. SCOPE
Upon notification from the IRB that a study is closed, Research Finance has 35 days from the closure date to submit a final invoice for reimbursement as well as to close out the study in Epic. To fully meet this expectation, communication with the Research Quality Specialist Team is key and is described in more detail below.
3. RESPONSIBILITIES & SPECIFIC PROCEDURE
This SOP applies to Children’s Health Finance and Quality Specialist groups in Research
Administration.
3.1 The study close out process is initiated when the Financial Analysts receive an email notification from the Quality Specialists that the IRB has approved the study for closure.
3.2 The Quality Specialist will request confirmation from the Financial Analyst of any outstanding charges that need to be invoiced.
3.3 The Financial Analyst will review the most current fully executed Service Order Agreement (SOA) and prepare a final invoice to include the following fees, as applicable:
-IRB Close out fee
-Close out monitor visit
-Close out pharmacy monitor visit
-Long Term storage
-One-time lab charges
-CRC/CRA Start-up fee
-CRC time for screening failures (if applicable) -Other fees to consider (if applicable)
-CRC time for queries -CRC time for prescreen -CRC time for recruitment
This is not meant to be an exhaustive list. It only represents commonly included charges.