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Form overview

Forms (CRFs) are a mechanism that you use to collect study data. You use forms to enter, correct, or update data for the subject visit.

Form sample
Figure 1. Form sample

Important

Only users with the clinical research coordinator (CRC) role are allowed to enter, clear, or update information in the forms.

If you are responsible for data entry in EDC, for your convenience all the tasks on CRF completion appear in the Requiring Completion section of the My Work dashboard.

In EDC, you enter data into five types of forms, as follows:

  1. Enter data into a simple form

  2. Enter data into a grid form

  3. Enter data into a log form

  4. Enter data into an eDiary form

  5. Enter data into a header detail form

Tip

Helpful information is available for the guidance of the clinical research coordinator (CRC) while they enter data into the forms. When a field or a question has Help Text help_text_icon.png next to it, select the icon to view the helpful information. This help text is configured from the Study Designer application.

Viewing help text
Figure 2. Viewing help text

Regardless of the form type, some fields of the form can be hidden. It depends on whether this field is disabled by a specific rule set by the clinical data manager (CDM) in the Study Designer application when designing CRF.

For example, the question "If female, is she of childbearing potential?" should obviously not be a question for a male subject, so the question will be hidden from the male subject form.

Example of form availability depending on other variables
Figure 3. Example of form availability depending on other variables

Some forms or individual fields can also be blinded via the Study Designer settings, so in EDC, only the specific users with the respective permissions can view such forms and fields.

The assignment of user roles that can view and manage the blind forms and fields occurs under the STUDY INFO > Study Information module of EDC.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

A person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.

An eClinical application that provides functionality to design and configure a study (clinical trial), namely to configure CRFs, set subject phases, visits, and others.

The application supports the design of the CDSIC ODM-compliant electronic CRFs to support EDC and eDiary data collection and management.

Get to know all the possibilities of the app with the comprehensive SD User Guide.

CRAs