Participant Types

The Participant Types section of the Protocol Tab allows you to identify certain categories of participants and the expected number to be included in the research locally (count).

Involving certain subject populations (e.g., Children) necessitates completing associated Questionnaires on the Questionnaire Tab. Be sure you select all applicable participant types/vulnerable populations here to invoke all required Questionnaires later.

Figure 641 Protocol Document, Protocol Page - Participant Types Section Example

Table 277 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.
Type	Select all of the following that apply from the drop-down list (click on the drop-down menu arrow to select a population): Children Decisionally/Cognitively Impaired Prisoners Pregnant Women/Fetuses/Neonates Students Economically/Educational Disadvantaged, or Transnational Participants Total* *Total is required for all studies with Protocol Type = Full Board, Expedited or Exempt. Other Participant Types may be added, as applicable.
Count	Enter a numeric value to represent the maximum number of participants to be included locally of the particular type. Count value is required for Participant Type = Total. Count value is optional for any other participant types identified. If you have not yet determined a firm maximum enrollment number, the Count should represent your best estimation. For example, if you expect to enroll 100 per year and the study will be open for approximately 10 years, enter “1000” for the Total.
Actions	Click the button to add your selection/entry as a numbered line item row in the table below. Once a Participant Type has been added as a line item, you can click delete as needed. For more information about basic line item functionality, see “Common Line Item Operations” in Common E-Doc Operations.

Duplicate Participant Types are not permitted in multiple lines. After you’ve selected a value from the Description list, that value 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.