About visits

In the InForm Architect application, visits are collections of forms. Most visits represent actual patient visits to an investigative site, and the forms are CRFs used to collect the data obtained from the patient at that visit. Additionally, the InForm Architect application supports the following types of specialized visits:

Screening and Enrollment—In the InForm application, screening and enrollment is a two-step process. To register a patient on a Screening Log, users submit a screening form. To enroll a screened patient, users submit a form that captures enrollment criteria. The Screening visit, containing a screening form, and the Enrollment visit, containing an enrollment form, are required components of an InForm application trial.
Dynamic—The InForm application supports the creation of visits that are generated automatically when patient data satisfies certain criteria that you test by attaching a rule to the relevant data item or items. For example, if you want to create a different sequence of visits for patients who are randomly assigned to receive different dosages of a drug in the third visit of a trial, you can do this by setting up dynamic visits.
Monitoring—The InForm Architect application enables you to create the following types of forms to support site monitoring:
- A Site Visit Report records data about a visit to a site.
- A Regulatory Documentation Checklist records information about a review of site documents.
Each of these monitoring forms is included in a visit with special properties to identify it. Use the Visit Report default visit for Site Visit Reports, and use the Reg Docs default visit for Regulatory Documentation Checklist forms.

Along with these types of visits, the InForm Architect application supports the creation of associations between related types of forms. When forms are related in an association, data from both forms in the association is accessible when a user works with either form in a running trial, and special controls make it easy to navigate between associated forms.

When you create a new trial, the InForm Architect application includes definitions of each type of special visit as default visits and creates a node for associations. These visits occur in a specific order in the trial definition, and you should not change this order. You can add or remove forms in these visits as you would with regular visits. However:

You can have only one screening form and one enrollment form per trial.
You cannot remove forms from an association after its definition has been installed in the InForm application trial database.

All visits have one or more of the following major characteristics:

Scheduled or unscheduled—Scheduled visits occur in a fixed relationship to the beginning of a patient’s enrollment in a trial. Scheduled visits start a specified number of hours after enrollment. Unscheduled visits are not on a specific timeline.
Optional or required—The optional and required characteristics specify whether a trial can be considered complete if a visit has no data. If a visit is required, the InForm application indicates incomplete status on summary screens and on the Case Book list and Time and Events schedule.

Note: Optional visits are not currently supported.

Repeating—Repeating visits are unscheduled visits in which the user determines how many visits occur and on what schedule. Site visit reports are examples of repeating visits.