1.4.6 Frequently Used Terms

• If the Participate module is activated, participants can enter data themselves.
• If the Randomize module is activated, participants can be randomly assigned to groups (e.g., placebo or treatment) without bias from demographics such as age, sex, or gender.

• Visit-based, non-repeating: A scheduled occurrence (e.g., Baseline)
• Visit-based, repeating: A repeatable scheduled or unscheduled occurrence (e.g., Cycles in Oncology trials, Unscheduled Visits)
• Common, repeating: An unscheduled but repeatable occurrence (e.g., Adverse Event)
• Common, non-repeating: An unscheduled, one-time occurrence (e.g., Termination)

• Items – individual data fields (e.g., blood pressure, date of visit).
• Constraints – rules that define acceptable input values (e.g., numeric ranges, required fields).
• Relevance logic – conditional rules that show or hide fields based on prior responses.
• Calculations – auto-derived values (e.g., BMI from height and weight).
• Metadata – labels, instructions, and coding standards to ensure consistent data entry.

Users with the appropriate level of form access can enter data into a Form.

• If the Participate module is activated, a form can be published as a Participate Form, allowing participants to enter data from their own devices.
• If the Consent module is activated, a form can be published as an eConsent Form, allowing participants to provide consent in a manner compliant with 21 CFR Part 11.

• Manage participants / events
• View/enter data
• Create, update or close queries
• Perform Source Data Verification (SDV)
• Import data
• Extract data