Adding Subjects to Study
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Each study has a primary form that must be completed before a subject is added to the system. The fields on the primary form are used to derive the subject's name within the study. When the form is submitted, the new subject is added to the site within the study. You can edit the form after initial enrollment if you have permissions but you cannot delete the form.

You must meet the following conditions prior to adding a new subject:

• Have "Create Subject" permission

• Have "Modify Primary Record" permission

• You must be assigned "Entry" Role Action

• You must have a CRF version pushed to a study site

• If you are adding a subject in DDE, the primary form must be a DDE form

• If you are adding a subject in EDC, the primary form cannot be a DDE form

• You must not have view or entry restrictions on the CRF version's primary form

• There must be no enrollment cap on the study site, or the number of subjects must be below the cap.

1. Navigate to a Study > Site.

2. Click Add Subject. A primary form for the new subject appears.

3. Where applicable, select an investigator from the Responsible Investigator dropdown within the subject status bar.

4. Enter appropriate data in the empty text fields.

5. Click Save.

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