The Participant Types section of the Protocol page allows you to add a participant type and optional count to a list of participant types for a protocol. It is not required that you use this section, but if you do, at least one Description must be selected and added as a numbered line item row. Upon saving the document, the information is recorded in the database.
Figure 1112 Protocol Document, Protocol Page - Participant Types Section Example
Table 327 Protocol Document, Protocol Page - Participant Types Section Column Descriptions
Column |
Description |
Add / # |
Indicates the sequentially numbered line item rows in ascending, top-to-bottom order. |
Description |
Required. Select one of the following from the predefined list of participant descriptions: Children, Other, Decisionally impaired, Employees, Prisoners, Pregnant women, Fetuses, Students, Students – minors, or Wards of the state. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection. Descriptions depicted in this documentation may differ from your system, as this list is configurable by implementing institution. See the “Participant Type” on page 1625 in Maintenance > Compliance (Participant Type Description maintenance document) for more information. |
Count |
Type to enter a numeric value to represent the amount of participants for this type. If you leave it blank, it means that this class of participants will be used, but the number is unknown at the time of the protocol submission. It does not have to be used just to track protected populations. |
Actions |
Click the add button in the Add row to add your selection/entry as a numbered line item row in the table below. Click delete or view as desired. For more information about basic line item functionality, see “Common Line Item Operations” in Common E-Doc Operations. |
Duplicate Participant Types in multiple lines are not permitted. After you’ve selected an option from the Description list once, it is removed from the list and no longer available for selection. When you delete a line item, that type becomes available in the list again. |