Project & Financial Entity Relationships: New Protocol Disclosure

Figure 797 New IRB Protocol Disclosure > Disclosure > Project & Financial Entity Detail sub-panel – details hidden

This section contains two (2) sections. Expand the sub-panel by clicking the [>show]  toggle button. The upper section displays the protocol to be related to a reporter’s active Financial Entities. The lower section displays the list of financial entities. The parenthetical text in this banner keeps track of the number of entities that must be reviewed to complete this section’s requirements. Example: (0/1 Reviews Complete). When the entities in this section have been related, the banner text will update.

 

 

Figure 798 New IRB Protocol Disclosure > Disclosure > Project & Financial Entity Detail sub-panel > expanded details section

 

This section of the Disclosure page displays the reporter’s Protocol details and a subsection for the Financial Entities.  The IRB Protocol Name, IRB Protocol Type, Application Date, Expiration Date, and PI Name are displayed to identify the record. The Financial Entities subsection displays the following four columns: Review, Entity, Related, and Comments.

 

The overall disclosure disposition   for the project is also displayed on the header panel.

 

Table 258 New IRB Protocol Disclosure > Disclosure > Project & Financial Entity Detail>Entity field definitions

Field

Description

Review

(column)

This column contains the View, Edit, and History function buttons that allow the user to access the details of the financial entity. Close the box to continue with your disclosure.

View

Click the view button to display the financial entity details window in a light-box window.

Edit

Click the edit button to open this financial entity and modify the entry. When you finish your edit and submit or cancel, you will return to the disclosure.

History

Click the history button to display a table that summarizes the updates made to this financial entity. Close the box to continue with your disclosure.

Entity (Column)

This column contains the (create) “new financial entity” button in the leading row, and the name of the reporter’s financial entity in the detail rows.

 

New financial entity

Click the new financial entity button  to open the entry screen to define an entity. See the section on Financial Entity maintenance for complete instructions. When your entity maintenance is complete and you submit or cancel, you will return to the disclosure.

Related

(column)

This column header contains the quick-entry selection option to assign the entity relationship status to every financial entity. Click on the “select” drop-down list  tool to assign a financial entity relationship status for all financial entities. The values available for selection for the reporter are No Conflict Exists, Potential Relationships and Relationships Identified. Once an option is selected, the related column for each financial entity is populated with the selection.

Select

Click on the “select” drop-down list  tool to assign a financial entity relationship status on an item-by-item basis. The values available for selection for the reporter are No Conflict Exists, Potential Relationships and Relationships Identified.

Comments

This section is used to provide additional explanatory text.

 

Adoption of Project-FE relatedness status with the highest numerical value as project and disclosure status

When multiple financial entities are related to a project, the system adopts the highest number of the project-fe statuses selected by the reporter for the status display at the project and disclosure level. This can be seen after the reporter selects the project-fe relationship and performs a save action.

note.png    The statuses No Conflict Exists, Potential Relationships and Relationships Identified are maintained within the Maintenance Table COI Disposition Status. The calculation of which project-fe status to select as the overall status for the project/disclosure is based on the value of the numeric COI Disposition Code. The system considers lower values as “good” statuses and higher values as “bad” statuses.

 

COI Disposition Code

COI Disposition

210

No Conflict Exists

310

Potential Relationship

320

Relationship Identified

 

As shown in the example below, the COI Disposition value for value for “Potential Relationship” i.e. 310 is higher than the COI Disposition value for “No Conflict Exists” 210. Hence the system adopts the higher value status for the project level disclosure status.

Figure 799 New IRB Protocol Disclosure > Disclosure > Project & Financial Entity Relationships >Related ; Protocol header panel disposition

The Status of the Disclosure on the header panel is derived from the project-fe status with the highest value.

Figure 800 New IRB Protocol Disclosure > Disclosure header panel > Status