Manual IRB Protocol Event Type:

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Manual IRB Protocol Event Type:

Figure 563 COI > Manual Event & Financial Entities sub-panel with Manual IRB Protocol event type selected

The IRB Protocol Event Type subsection requires the following data fields to be maintained:

Table 250 COI > Manual Event & Financial Entities > Manual IRB Protocol event type field definitions

Field	Description
Event Type	This selection was made in the previous step, but can be changed to another type in this field. Changing the Event Type will change the required data elements that follow. This section describes Manual IRB Protocol.
Protocol Number	Enter the protocol number in this field.
Protocol Name	Enter the name of the protocol in this field.
Protocol Type	Select the protocol type from the drop-down list.
Add	Click the Add field to save the entered details. You must define all the data fields.

Once the Event Type has been successfully added, subsections for the project details and the financial entities will appear. Also, the Questionnaire Sub-panel may generate if one has been defined for this manual disclosure type. Complete the requirements in both sections.

Figure 564 COI > Questionnaire & Manual Event & Financial Entities sub-panels with Manual IRB Protocol event added.

The Manual Event and Financial Entities sub-panel contains two (2) subsection. If it isn’t already, expand the sub-panel by clicking the [>show] toggle button. The upper section displays the new manual project to be related to a reporter’s active Financial Entities. The lower section displays the list of active 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 565 COI > Manual IRB Protocol Event & Financial Entities sub-panel> Financial Entities section

The Project details entered in the prior step are displayed to identify the record. The Financial Entities subsection displays the following four columns: Review, Entity, Related, and Comments.

Table 251 COI > Manual IRB Protocol Event & Financial Entities sub-panel> Financial Entities section 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 buttons to assign the entity relationship status to every financial entity. The detail row contains the drop-down selector to assign the relationship status on an item by item basis.

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