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You use forms to enter, correct, and update data for patient visits. These forms are all electronic and can be entered onsite by site users, who complete Electronic Data Capture (EDC) forms, or over the Internet by patients completing Electronic Patient-Reported Outcome (ePRO) forms.
When you edit EDC forms, the changes appear in the audit trail for the form. Because patient responses to ePRO forms are entered only once and cannot be edited by site users, there is no audit trail for ePRO forms.
Your study might contain several different form types.
Types of forms
Form type | Description |
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Flat | Most OutcomeLogix forms are flat forms. Each completed flat form becomes one record in a database file. |
Dynamic | Used to customize the items in the form based on a particular field entry. For example, questions regarding pregnancy might appear only on forms administered to female patients. When the patient enters the gender, the form refreshes with the dynamically generated questions. |
Patient forms | Patient-entered ePRO forms viewable by users with appropriate permissions. See Reviewing patient forms. |
Repeating | Used to collect the same data at each visit or complete multiple instances of the same form. Also known as a log form. |
Adverse Event | Specific repeating form that tracks adverse reactions. |
Repeating sections | When a patient response can include multiple entries; for example, symptom reported, a form has repeating sections. Depending on the study design, the user adds the sections as needed or the study has predefined a set number of repeating sections. When opened, repeating sections appear in EDC and ePRO forms with a border around the section. |
Tabbed ePRO forms | Large forms split into several small sections, where each tab represents a subsection of the larger form. |
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