Non-clinical forms

Regulatory documents and visit reports, which are monitoring forms, are custom forms used by monitors when they visit sites. You are not required to create monitoring forms. If you do not create the forms, default forms are created and deployed with the study.

• Visit report form—A form that a CRA uses to report findings from a site visit. A visit report form cannot be repeating but can contain a repeating section.
• Regulatory document form—A form that a CRA uses to record whether required regulatory documentation, such as the study protocol, IRB approvals, and electronic signature reporting documentation, is available and up to date. A regulatory document form is not repeating by default, but you can mark it as repeating.

During deployment, a study event is created for each monitoring form.

You can create one of each type of form in a study, and you can create multiple forms in a library.

Note: You can create monitoring forms only in the NonClinical container in the Project Explorer.