Inclusion Enrollment Report

Standalone PHS Inclusion Enrollment Report forms are no longer used. Instead, data collection for up to 20 Inclusion Enrollment Reports has been folded into each Study Record.

For specific information, please go to How to Apply - Application Guide, then click Research Instructions, and search the resulting document for "Inclusion Enrollment Report".

Click on the Closed toggler arrowAdd New Inclusion Enrollment Report button in Section 2 of the Study Record screen to initiate the Inclusion Enrollment Report.

Initiate IER

For each Inclusion Enrollment Report, applicants must indicate whether an existing dataset or resource will be used and whether the enrollment location type is domestic or foreign.

There are also a few optional fields in the report, including a text entry Comments field. (Closed toggler arrowclick to view top part of IER)The Inclusion Enrollment Report Title field should be unique to help you identify the report. The human subjects study title appears by default for all existing studies but can be changed. For new users and those with a work in progress study, the title is blank and must be filled out.

top part of Inclusion Enrollement Report

Planned and Cumulative enrollment data is entered into two separate tables. (Closed toggler arrowclick to view tables)

bottom part of Inclusion Enrollement Report screen

Editing Cumulative (Actual) Inclusion counts

  • There are two ways to edit the existing Inclusion Enrollment Report (IER) data for Cumulative (Actual) counts:
    1. You can update the cells online in the existing report in the web form.
    2. You can upload participant-level data using the Upload Participant Level Data Attachment button. This is required for some applications (see Notes).
  • Notes:

    To use the template:

    Cumulative (Actual) totals sections showing active buttons

    You can click on the Download Current Participant Level Data button to download the file containing the data for your own records.

    For Closed toggler arrowPlanned counts, the cells must be updated online in the report itself.

    Planned totals table