Purpose
The following guide is intended for Clinical Research Finance Managers who are looking to view or complete any of the following actions:
Action
· Set up Award with Clinical Research Organization (CRO) Relationship
· Reflect CRO relationship in a CRS Award (Draft Status) integrated from Artemis.
· CRS - Process Cost on CRO Award
· Process Invoice on CRO Award
· Process Revenue on CRO Award
· Process Payment from CRO
· Process Refund to CRO
· Transfer of the pending amount back to the Primary Sponsor upon the conclusion of the CRO trial
Terminology
· Clinical Research Organizations (CRO): Clinical Trial projects are frequently managed by Clinical Research Organizations (CROs), which oversee the trials on behalf of the sponsor
· The CRO handles invoicing and payments for the trial expenses, acting as an intermediary between the sponsor and various service providers. When transitioning clinical trial sponsors with established CRO relationships, a crucial step involves assigning the appropriate CRO
· The CRO must be configured as a customer within the Oracle system.
· Establishing the CRO as a customer ensures that the relationship settings, including Reciprocal, Bill-To, and Ship-to, are properly configured
Reflect CRO Relationship in a CRS Award (Draft Status) integrated from Artemis
CRS - Process Cost on CRO Award
Transfer of the pending amount back to the Primary Sponsor upon the conclusion of the CRO trial
Reflect CRO Relationship in a CRS Award (Draft Status) integrated from Artemis
After the seamless integration of Artemis with Oracle PPM, it is crucial to navigate through the essential checklist steps in the Project, Award, and Contract pages to ensure thorough validation of the Award.
1. Refer to Artemis to Oracle PPM Cloud Integration checklist for steps 1-32 in the hyperlinked checklist to populate CRO in a CRS Award.
2. Initiate Steps 33:
a. Bill details for CROs (Clinical Research Organizations) and Primary Sponsor
i. Bill to Customer and Ship to Customer: SAME (Refer to Screen A)
ii. Bill to Customer: CRO and Ship to Customer: Primary Sponsor (Refer to Screen B)
Screen A:
Screen B:
Then, work through step 34 steps outlined in Artemis to Oracle PPM Cloud Integration checklist.
CRS - Process Cost on CRO Award
Refer to the following QRGs to capture Cost on CRO Award. These processes will transfer Cost to CRO Award:
· Regular requisitions: Create PO Req for Goods against Award
· Create Subaward Requisition -Grants Management Knowledge Base Article
· SubAward Requisitions: Create Subaward Requisition and submit for approval, approve requisition.
· Create Subaward Requisition CTFG Knowledge Base Article
· SubAward Invoices: Receive a Subaward Invoice and Complete the Approval Workflows
· Initiate Subaward on a Sponsored Award - Managing Invoices Knowledge Base Article
· Post a Cost Transaction and Create F&A Transaction (Generate Burden) on a Converted Award
· Manage Indirect cost adjustments for CRS Knowledge Base Article
Process Invoice on CRO Award
Refer to the Invoice Clinical Research Studies Knowledge Base Article
Process Revenue on CRO Award
1. Select the OKTA Single-Sign-On button and then complete the sign-in steps.
2. Navigate to Contract Management.
3. Select Revenue.
4. On the Task Panel, select Generate Revenue.
5. Fill in the below fields and select Submit:
a. Business Unit: University Clinical Research Studies
b. From Date
c. To Date
6. Select the Task Panel and then Manage Revenue Distributions.
7. Enter Business Unit, Accounting Period, and the Revenue in Ledger Currency.
8. Select Actions then Post to Ledger.
9. Once the confirmation comes up, select View Accounting.
10. Review accounting on the page. To close, select Done.
Process Payment from CRO
Refer to the Receiving and Processing Customer Payments Knowledge Base Article
Process Refund to CRO
Refer to the Adjust a Receipt Application - Process Refunds, Write off, and Bad Debt Knowledge Base Article
Transfer of the pending amount back to the Primary Sponsor upon the conclusion of the CRO trial
Scenario: Johns Hopkins University serves as the primary sponsor, overseeing a trial where the CRO (Contract Research Organization) involved is IQVIA Biotech LLC. The trial has concluded, and despite IQVIA Biotech LLC no longer actively managing the study, there remains an outstanding balance of $15,000 in open Accounts Receivable (AR).
As the agreement with the CRO for the trial has terminated, consequently, there is a need for UC to receive payment for the outstanding $15,000. The recommended course of action is to facilitate the transfer of this pending amount back to the Primary Sponsor, Johns Hopkins University, as part of concluding the financial transactions related to the CRO-managed trial.
High Level Process:
Johns Hopkins University serves as the primary sponsor, overseeing a trial with the involvement of the CRO, IQVIA Biotech LLC. The following steps outline the financial transactions related to the trial:
· Navigate to Grant Administrator. An Award 200000018 was created with Primary Sponsor 'Johns Hopkins University' and CRO 'IQVIA Biotech LLC'.
· Navigate to Contract Management. a $15k project billing event was created for Award 200000018, reflecting the financial details associated with the trial.
· Navigate to Contract Management. A $15K project billing invoice was created for Award 200000018 with Bill to as CRO 'IQVIA Biotech LLC' and Ship to Primary Sponsor 'Johns Hopkins University'.
· Navigate to Schedule Processes. Run the 'Import AutoInvoice' Program to generate a $15k invoice in Accounts Receivable (AR). This invoice, with CRO 'IQVIA Biotech LLC' as the Bill-to entity and Primary Sponsor 'Johns Hopkins University' as the Ship-to entity, signifies an outstanding balance of $15,000 in open AR.
The trial has concluded, and IQVIA Biotech LLC no longer actively managing the study. As the agreement with the CRO for the trial has terminated, consequently, there is a need for UC to receive payment for the outstanding $15k.
· Navigate to Contract Management. Cancel the $15K project billing invoice that was created for Award 200000018 with Bill to as CRO 'IQVIA Biotech LLC' and Ship to Primary Sponsor 'Johns Hopkins University'. This cancellation will generate a Credit Memo invoice of $15k.
· Navigate to Schedule Processes. Run the 'Import AutoInvoice' Program to transfer the Credit Memo Invoice to Accounts Receivable (AR), designating CRO 'IQVIA Biotech LLC' as the Bill-to entity and Primary Sponsor 'Johns Hopkins University' as the Ship-to entity. This process will effectively offset and clear the outstanding balance of $15k in open AR.
The recommended approach involves facilitating the transfer of the pending amount back to the Primary Sponsor, Johns Hopkins University, to conclude the financial transactions associated with the CRO-managed trial. Here's the step-by-step process:
· Navigate to Contract Administrator. Open Contract 200000018 and override the Bill-to details from CRO 'IQVIA Biotech LLC' to Primary Sponsor 'Johns Hopkins University.' Activate the Contract.
· Navigate to Contract Management, run the generate invoice program for contract 200000018. This action will generate a new $15k Project billing invoice with both Bill-to and Ship-to details set to Primary Sponsor 'Johns Hopkins University.'
· Navigate to Schedule Processes. Run the 'Import AutoInvoice' Program to create a new $15k invoice in Accounts Receivable (AR) with both Bill-to and Ship-to details as Primary Sponsor 'Johns Hopkins University.' This represents the outstanding balance of $15,000 in open AR for the Primary Sponsor.
· Create a new receipt for $15,000 for Primary Sponsor 'Johns Hopkins University' and complete the payment process to effectively clear the outstanding balance.
Detailed Process:
Johns Hopkins University serves as the primary sponsor, overseeing a trial with the involvement of the CRO, IQVIA Biotech LLC. The following steps outline the financial transactions related to the trial:
1. Select the OKTA Single-Sign-On button and then complete the sign-in steps.
2. Navigate to Grants Management and then Manage Awards.
3. Search the Award 200000018 (was created with Primary Sponsor 'Johns Hopkins University' and CRO 'IQVIA Biotech LLC'.)
4. Select the award number hyperlink to open the award.
5. Navigate to the 4th Train stop Review to review billing details.
6. Navigate to Contract Summary Section.
7. Select the small blue icon under Billing Details to review the Contract billing details.
a. A $15k project billing event was created for Award 200000018, reflecting the financial details associated with the trial.
8. Navigate to the Task Panel.
9. Navigate to Manage Events.
10. Select the + sign and then Create New Event.
11. Fill out the Event details under Create Event.
Event Number 3 created with $15k
12. Navigate to Contract Management and then Invoices.
13. Select the Task Panel then Generate Invoices.
14. Fill out invoice details with:
a. Business Unit University Clinical Research Studies
b. Bill from Date
c. Bill-Through Date
d. Invoice Date
e. Contract Number
15. Select Submit.
16. Navigate to the Task Panel and then Manage Invoices.
17. Review the $15K project billing invoice that was created in Released Status for Award 200000018 with Bill to as CRO 'IQVIA Biotech LLC' and Ship to Primary Sponsor Johns Hopkins University.
18. Select Actions, followed by Transfer, then Transfer Invoice Details to Receivables.
19. Change status to Transferred.
20. Navigate to Tools, followed by Scheduled Processes, then Schedule New Process.
21. Search for Import AutoInvoice Process.
22. Populate the following fields:
a. Business Unit: Clinical Research Studies
b. Transaction Source: Contract Invoices
c. Default Date
23. Select Submit.
a. Note: This will run the 'Import AutoInvoice' Program to generate a $15k invoice in Accounts Receivable (AR). This invoice, with CRO 'IQVIA Biotech LLC' as the Bill-to entity and Primary Sponsor 'Johns Hopkins University' as the Ship-to entity, signifies an outstanding balance of $15,000 in open AR.
24. Select the Refresh wheel to refresh the scheduled process screen until the status is Succeeded.
25. Navigate to Receivables then Billing.
26. Navigate to the Task bar then Manage Transactions.
27. Select the Transaction number.
28. Review Customer Bill and Ship To addresses.
29. Navigate to Actions then View Balance Details.
30. Review details and select OK when finished.
31. Navigate to Receivables and then Billing.
32. Navigate to the Task Panel then Manage Transactions.
33. Search the transaction with the AR number and select the invoice.
34. Navigate to Actions then Post to Ledger.
35. Confirmation will show up that Accounting has been completed. Select View Accounting.
36. Review Accounting and once complete, select Done.
37. Navigate to Contract Management and then Invoices.
38. Select the Task Panel, then Confirm Invoice Acceptance Status in Receivables.
39. Select Business Unit as University Clinical Research Studies.
40. Select Submit.
41. Navigate to the Task Panel then Manage Invoices.
42. Enter the following fields and select Search:
a. Business unit
b. Contract number
c. Status
d. Date
e. Exception
43. Review search results Contract number, bill to customer, Amount in invoice currency, and receivables number,
44. Navigate to Home, followed by Contract Management, then Revenue.
Generate Revenue and Manage Revenue Distributions
45. Navigate to the Task Panel, then select Generate Revenue.
46. Enter the following details:
a. Business Unit: University Clinical Research Studies
b. From Date
c. To Date
47. Select Submit.
48. Navigate to the Task Panel and select Manage Revenue Distributions.
49. Under Manage Revenue Distributions, fill in the following and select Search:
a. Business Unit: University Clinical Research Studies
b. Interval
c. Accounting Period
50. Review the Revenue in Ledger Currency.
51. Select Actions from the drop down then Post to Ledger.
52. Confirmation will show once the accounting is complete. Select View Accounting.
53. Review Accounting and when complete, select Done.
The trial has concluded, and IQVIA Biotech LLC no longer actively managing the study. As the agreement with the CRO for the trial has terminated, consequently, there is a need for UC to receive payment for the outstanding $15k.
· Navigate to Contract Management. Create a new Billing event with -$15k for Award 200000018 with Bill to as CRO 'IQVIA Biotech LLC' and Ship to Primary Sponsor 'Johns Hopkins University'.
54. Navigate to Contract Management and then Invoices.
55. Select the Task Panel and then Manage Events.
56. Select the Plus Sign (+) to create a new event.
57. Create an event with the below fields populated and select Save and Close:
a. Business Unit
b. Contract Number
c. Contract Line
d. Event Type: Clinical Research Study Fee
e. Description: Clinical Research Study Fee
f. Amount in Bill Transaction Currency
g. Organization
58. Navigate to the Task Panel then Manage Events.
59. Under Search section, enter the below parameter and select Search:
a. Business Unit: University Clinical Research Studies
b. Contract number
c. Project Name
d. Project Number
e. Event Type
60. Review Event Number, Invoiced Percentage, and Recognized Revenue Percentage.
61. Navigate to Tools and then Scheduled Processes.
62. Select Schedule New Process.
63. Search Generate Invoice.
64. Populate the following fields:
a. Business Unit
b. Billing Type: External
c. Bill from Date
d. Bill-Through Date
e. Create Billing Transactions: Yes
f. Create Invoice: Yes
g. Invoice Date
h. Contract Number
65. Select Submit.
66. Navigate to the Task Panel and then Manage Invoices.
67. Search for the contract.
68. Review Contract Number, Bill to Customer, Amount in Invoice Currency, and Receivables.
69. Select the Actions drop down then Transfer Invoice Details to Receivables.
a. The Status of the Contract will now show as Transferred.
70. Navigate to Tools then Scheduled Processes.
71. Select Schedule New Process.
72. Search Import AutoInvoice.
73. Populate the following fields:
a. Business Unit: University Clinical Research Studies
b. Transaction Source: Contract Invoices
c. Default Date
74. Select Submit.
a. Note: Run the 'Import AutoInvoice' Program to transfer the -$15k Invoice to Accounts Receivable (AR), designating CRO 'IQVIA Biotech LLC' as the Bill-to entity and Primary Sponsor 'Johns Hopkins University' as the Ship-to entity.
b. This process will effectively offset and clear the outstanding balance of $15k in open AR.
75. Select the Process Refresh wheel until Status reads as Succeeded.
76. Navigate to Receivables and then Billing.
77. Select the Task Panel then Manage Transactions.
78. Open the Transaction Number.
79. Review the Bill To and Ship To details.
80. The original amount will show as -$15k.
81. Select Receivables and then Billing.
82. Navigate to the Task Panel then Manage Transactions.
83. Search the AR number.
84. Select Actions then Post to Ledger.
85. Confirmation will show when the accounting has been completed. Select View Accounting to view the accounting.
86. Review accounting lines and select Done when finished.
87. Navigate to Contract Management and then Invoices.
88. Select the Task Panel then Confirm Invoices Acceptance Status in Receivables.
89. Enter business Unit as University Clinical Research Studies and then select Submit.
90. Navigate Home, followed by Contract Management, then Invoices.
91. Select the Task Panel then Manage Invoices.
92. Search for the contract and review search results where the Amount in Invoice Currency has the $15,000 amount is offset and clear the outstanding balance of $15,000 in open AR.
93. Navigate back to the Home Screen and select Contract Management then Revenue.
94. Select the Task Panel then Generate Revenue.
95. Enter the below parameters:
a. Business Unit: University Clinical Research Studies
b. From Date
c. To Date
d. Contract Number
96. Select Submit.
97. Navigate to the Task Panel then Manage Revenue Distributions.
98. Enter the below fields and select Search:
a. Business Unit: University Clinical Research Studies
b. Accounting Period
c. Contract number
99. Review the search results.
100. Select Actions then Post to Ledger.
101. Confirmation will show when the accounting has been completed. Select View Accounting to view the accounting.
102. Review accounting lines and select Done when finished.
The recommended approach involves facilitating the transfer of the pending amount back to the Primary Sponsor, Johns Hopkins University, to conclude the financial transactions associated with the CRO-managed trial. Here's the step-by-step process:
· Navigate to Contract Administrator. Open Contract 200000018 and override the Bill-to details from CRO 'IQVIA Biotech LLC' to Primary Sponsor 'Johns Hopkins University.' Activate the Contract.
103. Navigate to Contract Management and then Contracts.
104. Input contract number and select Search.
105. Select Actions then Amend.
106. Select Ok.
107. Enter the Amendment Effective Date = System Date.
108. Navigate to Billing Tab.
109. Under the Bill Plans section, select the Pencil Icon.
110. Populate Bill to Account as Primary Sponsor.
111. Select Save and Close.
112. Select Submit.
a. Note: You can add a note to the Approve here.
113. Select Search and ensure that the Contract status changed to Active.
114. Navigate back to the home screen and select Grants Management then Manage Awards.
115. Select the Task Panel then Manage Awards.
116. Search the Award.
117. Select the Award and select the hyperlink number when it populates.
118. Select the 4th Train stop Review.
119. Under the Contract Summary section, select the blue Billing Details icon.
120. Review billing details Bill to Customer, Bill to Account, and Bill to Account Description.
a. Note: Bill to and Ship To are now showing with Primary Sponsor.
Create a new Billing event with $15k for Award 200000018 with Bill to and Ship to with Primary Sponsor Johns Hopkins University
121. Navigate Home, select Contract Management, and then Invoices.
122. Select the Task Panel then Manage Events.
123. Select the Plus Sign (+).
124. Populate the below fields:
a. Business Unit: University Clinical Research Study
b. Contract Number
c. Contract Number
d. Event Type
e. Description
f. Amount in Bill Transaction Currency of $15,000
125. Select Save and Close.
Run the generate invoice program for contract 200000018. This action will generate a new $15k Project billing invoice with both Bill-to and Ship-to details set to Primary Sponsor Johns Hopkins University
126. Navigate Home and select Contract Management and then Invoices.
127. Navigate to the Task Panel then Generate Invoices.
128. Populate the below fields:
a. Business Unit: University Clinical Research Studies
b. Billing Type: External
c. Bill-Through Date
d. Create Billing Transactions: Yes
e. Create Invoice: Yes
f. Invoice Date
g. Contract Number
129. Navigate to the Task Panel then Manage Invoices.
130. Search the Contract Number.
a. Review the Search results and the Status as Released with the $15,000 Amount in Invoice Currency.
131. Invoice created with Primary Sponsor Bill to Customer as Johns Hopkins University.
132. Select the Actions drop down then Transfer.
a. The Status of the Contract is now Transferred.
Run the 'Import AutoInvoice' Program to create a new $15k invoice in Accounts Receivable (AR) with both Bill-to and Ship-to details as Primary Sponsor 'Johns Hopkins University.' This represents the outstanding balance of $15,000 in open AR for the Primary Sponsor
133. Navigate to Tools, followed by Schedule Processes, then Schedule New Process.
134. Search Import AutoInvoice process.
135. Enter the following:
a. Business Unit: University Clinical Research Studies.
b. Transaction Source: Contract Invoices.
c. Default date
136. Select Submit.
137. Navigate to Home and select Receivables then Billing.
138. Navigate to the Task Panel and then Manage Transactions.
139. Search with AR number and Transaction source: Contract Invoices.
a. Navigate to the bottom of the page to see the invoice created for Primary Sponsor Johns Hopkins University.
140. Select the Transaction Number hyperlink.
141. Review Bill-to Information.
142. Select the Actions dropdown and then View Balance Details.
a. This represents the outstanding balance of $15,000 in open AR for the Primary Sponsor.
143. Navigate to Receivables then Billing.
144. Select the Task Panel then Manage Transactions.
145. Search with the below and then select Search:
a. Transaction Source: Contract Invoices
b. Transaction Number
c. Transaction Date
d. Bill to Customer
146. Once the item has populated select the Actions drop down then Post to Ledger.
147. Select the Actions drop down again and select View Accounting.
148. View Accounting then select Done.
149. Navigate to Contract Management then Invoices.
150. Navigate to the Task Panel then Confirm Invoice Acceptance Status in Receivables.
151. Input the fields with Business Unit of University Clinical Research Studies and select Submit.
152. Navigate to the Manage Invoices Tab.
153. Search with the below parameters:
a. Business Unit
b. Contract type
c. Status
d. Date
e. Exception
154. Review the search results.
155. Navigate to Contract Management then Revenue.
156. Navigate to the Task Panel then Generate Revenue.
157. Populate the fields:
a. Business Unit: Clinical Research Studies
b. Billing Type: External
c. From Date
d. To Date
e. Contract Number
158. Select Submit.
159. Navigate to the Task Panel then Manage Revenue Distributions.
160. Highlight the Contract line and then select Actions followed by Post to Ledger.
161. View Accounting the select Done.
Create a new receipt for $15,000 for Primary Sponsor 'Johns Hopkins University' and complete the payment process to effectively clear the outstanding balance.
Refer to the Knowledge Base Article for Invoice Clinical Research Studies.
Refer to the Knowledge Base Article for Receiving and Processing Customer Payments.