Purpose
The following guide is intended for Clinical Research Finance Manager(s) who are looking to view or complete any of the following actions:
· Update an award in Oracle.
· Update a project in Oracle.
· Update a contract in Oracle.
· Submit contracts for approval in Oracle – Award and Contract are self-approved. No approval process.
Action
· Add a Funder to an Existing Trial After it has Already Begun.
· Access the Project and Change the Project Name.
· Access the Project and Change the Resources (Manager) on a Project.
· Access the Project and Add an Additional Resource.
· Add Funding to an Existing Trial (Re-budget).
· Decrease Funding to an Existing Trial (Re-budget).
Terminology
· Award: Clinical Research Studies Trial (CRS) Awards are grants, funding, or financial support provided to researchers or medical institutions to conduct clinical trials and studies. All clinical study projects managed by OCR/CTFG will start with "CRS".
· Project: Contains financial and demographic information at a more granular level of detail than the award.
· Contract: Vehicle for processing revenue and invoices according to configured methods and controls.
· Burden Schedule: Tool for calculating and applying F&A or any other rate-based add-on cost.
· An Increased funding scenario would entail:
· Editing the funding (e.g, retrieving the funding record and changing the funding from $200K to $250K).
· Editing the funding allocation.
· Increase the project budget so that it is less than or equal to the “to-be” funding allocated to the project (probably will already be such that budget <= funding allocation).
· A decrease funding scenario would entail:
· Decreasing the project budget so that it is less than or equal to the “to-be” funding allocated to the project (probably will already be such that budget <= funding allocation).
· Editing the funding (e.g., retrieving the funding record and changing the funding from $250K to $200K).
· Editing the funding allocation.
Modify Clinical Study Award and Include CROs (Clinical Research Organization) as "Bill to" Account and Maintain Sponsor (Funder) as "Ship To" Account
Note:
a) If Award is in Draft Status, then include the CRO details in Award > (4) Review Tab > Biling Details.
b) If Award is in Active Status, then follow the below steps and include CRO details in Contract Management.
1. Login using Company Single Sign-On to access your Oracle account.
2. Navigate to Contract Management.
3. Select Contracts.
4. Enter Contract Number.
5. Select the Search button.
6. Scroll down to Search Results and select the Contract Number hyperlink.
7. Navigate to Actions.
8. Select Amend.
9. Select OK.
10. Enter Amendment Effective Date: today's date.
11. Select Save.
12. Navigate to Billing.
13. Select Award Bill Plan.
14. Select Actions.
15. Select Edit.
16. Enter Clinical Research Organization Details (Ex- IQVIA):
a. Bill-to Account Number: 100005004,
b. Bill-to Account Description: IQVIA Holdings Inc (CRO),
c. Bill-to-Party: IQVIA Holdings Inc (CRO), Bill-to Contact: Grants Payable, and Bill-to Site: 10000000025000
17. Select Save and Close from Save dropdown. You will be brought back to the Edit Contract page.
18. Select Submit.
19. On the Submit Contract page select Submit.
20. Select Save and Close from Save dropdown.
21. Select the Home icon.
22. Navigate to Grants Management.
23. Select Awards.
24. Select Taskbar.
25. Select Manage Awards.
26. Search for the award by entering the award number in search box.
27. Select the award name/number hyperlink.
28. In the top right corner, select Edit.
29. Select Review whistle stop.
30. Scroll down and select Billing Details icon.
31. Review the Clinical Research Organization details.
You have now completed the process to Modify Clinical Study Award and Include CROs (Clinical Research Organization) as "Bill to" Account and Maintain Sponsor (Funder) as "Ship To" Account.
Add a Funder to an Existing Trial After it has Already Begun
1. Login using Company Single Sign-On to access your Oracle account.
2. Navigate to Grants Management.
3. Select Awards.
4. Select the Taskbar.
5. Navigate to Manage Awards.
6. Select Show Filters and search for your Award.
7. Select the award name/number hyperlink.
8. In the top right corner, select Edit.
9. Select the Financial Tab.
10. Underneath Funding Sources, select the Cost shared by internal resources (if applicable).
11. Select the ‘+’ icon to add an internal funding source, if applicable.
12. Select Name: Internal (if the cost to be shared with department operational budgets or name of specific gift/endowment), Required By Sponsor (optional), Approved By (optional), and Approved Date (optional). Note: Do steps 11 and 12 only if the cost shared by internal sources is checked.
13. Scroll to the top and select Save.
14. Select the Projects whistle stop (top of the page, labeled #2 in the sequence).
15. Highlight the project to which the funding source will be added.
16. Select the down-arrow to the right of the Funding Source field.
17. Add the new funding source by selecting the check box to the left of the funding source name.
18. Select Save.
19. Select the Funding whistle stop at the top of the page.
20. Select Add Funding.
21. In the Add Funding window, select Budget Period (the budget period gets populated automatically if only one budget period is present).
22. Select Funding Source.
23. Enter Number, Date (the beginning of the funding period), Description (is optional), Direct Funding Amount, and Indirect Funding Amount. Note: Verify that the total obligated (direct & indirect) funding is entirely allocated among one or multiple projects. The allocated funding across projects represents the total obligated funding.
24. Select Save and Close.
You have now completed the process to Add a Funder to an Existing Trial.
Access the Project and Change the Project Name
1. Login using Company Single Sign-On to access your Oracle account.
2. Navigate to Projects.
3. Select Project Financial Management.
4. Select the chevron next to Search.
5. Enter your Project Number in your search.
6. Keep the Team Member field blank.
7. Click Search.
8. Select your Project in the search results.
9. Select the Taskbar.
10. Select Manage Financial Project Settings.
11. In the Basic Information section, select Edit.
12. Update the Project Name.
13. Select Save and Close.
You have now completed the process to Access the Project and Change the Project Name.
Access the Project and Change the Resources (Manager) on a Project
1. Login using Company Single Sign-On to access your Oracle account.
2. Navigate to Projects.
3. Select Project Financial Management.
4. Select the chevron next to Search.
5. Enter your Project Number to your search.
6. Keep the Team Member as blank.
7. Click Search.
8. Select your Project in the search results.
9. Select the Taskbar.
10. Select Manage Project Resources.
11. Select Add Resources.
12. Enter the following information:
a. Resource (For example prefix starting with CRS)
b. Project Role
c. From Date
d. To Date
e. Effort (Enter the individual's effort or leave blank)
f. Allocation (Adjust the allocation or leave it as default)
13. Select Save and Close.
14. If there is an existing resource that is no longer applicable/active, select the black arrow next to that individual's name.
15. Select Update (DO NOT select Delete or Replace).
16. On the Update Project Resource page, enter an end date in the To Date field.
17. Select Save and Close.
18. Select Save and Close.
You have now completed the process to Access the Project and Change the Resources (Manager) on a Project.
Access the Project and Add an Additional Resource
1. Login using Company Single Sign-On to access your Oracle account.
2. Navigate to Projects.
3. Select Project Financial Management.
4. Select the chevron next to Search.
5. Enter your Project Number to your search.
6. Keep the Team Member field blank.
7. Click Search.
8. Select your Project in the search results.
9. Select the Taskbar.
10. Select Manage Project Resources.
11. Select Add Resources.
12. Enter the following information:
a. Resource (For example prefix starting with CRS)
b. Project Role
c. From Date
d. To Date
e. Effort (Enter the individual's effort or leave blank)
f. Allocation (Adjust the allocation or leave it as default)
13. Select Save and Close.
14. You will be brought back to the Manage Project Resources page. Select Save and Close.
You have now completed the process to Access the Project and Add an Additional Resource.
Add Funding to an Existing Trial (Re-budget)
1. Login using Company Single Sign-On to access your Oracle account.
2. Navigate to Grants Management.
3. Select Awards.
4. Select the Taskbar.
5. Navigate to Manage Awards.
6. Select Show Filters and search for your Award.
7. Select the award name/number hyperlink.
8. In the top right corner, select Edit.
9. Select the Funding whistle stop.
10. Under Funding Summary, highlight the budget line to highlight the row.
11. Select the pencil icon to edit the funding. Note what the total funding currently is (before we modify).
12. Update the Direct Funding Amount and the Indirect Funding Amount.
13. Under Project Funding Allocation select the ‘+’ icon to allocate project funding.
14. Select Save and Close.
15. Select Validate.
16. A confirmation message will pop-up, select OK.
17. Select the Review whistle stop.
18. Under Award Project Summary highlight your project.
19. Select Manage Project Budget.
20. Select Version 2 (Current Working). Note: If Version 2 is missing then proceed as follows: 1) Select Version 1 > 2) Navigate to the right-hand side > 3) Select Duplicate.
21. Within the Edit Budget screen, highlight Task 1- General Expenses.
22. Select the Action dropdown menu.
23. Select Manage Assignments for Selected Tasks.
24. On the Manage Assignment for Selected Tasks page, search for the desired Planning Resource.
25. Click the ‘+” icon to add to the budget (select the ‘+’ icon next to Salary and Wages).
26. Select Save and Close.
27. Highlight Salary and Wages under task 1.
28. Select the chevron next to Actions.
29. Select Edit Period Amounts.
30. Select Planning Resource as Salary and Wages.
31. Enter the monetary amount that should be budgeted in the Burdened Cost field and Raw Cost field.
32. Select Save and Close.
33. Now, still in the pop-up window, select the down arrow next to planning resources.
34. Select Materials and Supplies.
35. Reduce the Burdened Cost field and Raw Cost field total.
36. Select Save.
37. Select the down arrow next to planning resources.
38. Select Indirect Expense.
39. Enter the monetary amount that should be budgeted in the Burdened Cost field.
40. Select Save and Close.
41. Review the budget for Other General Cost and confirm it is correct.
42. Select Create Baseline in right-hand corner of screen.
43. Select OK.
44. Select Done.
You have now completed the process to Add Funding to an Existing Trial (Re-budget).
Decrease Funding to an Existing Trial (Re-budget)
1. Login using Company Single Sign-On to access your Oracle account.
2. Navigate to Grants Management.
3. Select Awards.
4. Select the Taskbar.
5. Navigate to Manage Awards.
6. Select Show Filters and search for your Award.
7. Select the award name/number hyperlink.
8. In the top right corner, select Edit.
9. Select the Review whistle stop.
10. Under Award Project Summary highlight your project.
11. Select Manage Project Budget.
12. Select Budget Version.
13. Within the Edit Budget screen, highlight task 1, General Expenses.
14. Select the chevron next to Actions.
15. Select Manage Assignments for Selected Tasks.
16. On the Manage Assignment for Selected Tasks page, search for the desired Planning Resource.
17. Click the ‘+’ icon to add to the budget (select the ‘+’ icon next to Salary and Wages).
18. Select Save and Close.
19. Highlight Salary and Wages under task 1.
20. Select the chevron next to Actions.
21. Select Edit Period Amounts.
22. Select Planning Resource as Salary and Wages.
23. Enter the monetary amount that should be budgeted in the Burdened Cost field and Raw Cost field (for this scenario, please remove $200,000).
24. Select Save and Close.
25. Now, still in the pop-up window, select the down arrow next to planning resources.
26. Select Materials and Supplies.
27. Increase the Burdened Cost field and Raw Cost field total (by $100,000 in this scenario).
28. Select Save.
29. Select the down arrow next to planning resources.
30. Select Indirect Expense.
31. Enter the monetary amount that should be budgeted in the Burdened Cost field (for this scenario, please subtract $30,000 from the total).
32. Select Save and Close.
33. Review the budget for Other General Cost and confirm it is correct.
34. Select Create Baseline in right-hand corner of screen.
35. Select OK.
If you only wanted to adjust the budget, you have completed all the necessary steps. If you would also like to update the funding amount, proceed with the following instructions:
36. Select the Funding whistle stop.
37. Under Funding Summary, highlight the budget line to highlight the row.
38. Select the pencil icon to edit the funding.
39. Update the Direct Funding Amount and the Indirect Funding Amount (in this scenario, please subtract $100,000 in direct and $30,000 in indirect).
40. Under Project Funding Allocation select the ‘+’ icon to change the total funding amount to match the total funding amount above.
41. Select Save and Close.
42. Select Validate.
43. A confirmation message will pop-up, select OK.
44. Select Done.
You have now completed the process to Decrease Funding to an Existing Trial (Re-budget).