Study Record - Section 2 Study Population Characteristics

Section 2 is used to capture conditions and eligibility criteria as well as demographic information.

This section is required for all human subject studies, unless exemption 4 applies.

For Conditions or Focus of Study, use the Add New Condition button in Section 2 to enter up to 20 conditions or areas of focus, each of which is limited to 255 characters.

If you view this form in Post Submission, then question 2.8 directs you to answer the Enrollment of First Participant question in section 6.3, which appears only in Post Submission.

The last item in this section is for inclusion reporting. When you click the Add New Inclusion Enrollment Report button, the intake form for the inclusion enrollment report opens. See the IER page for more detail.