CRF / eCRF Design

CRF design principles, annotations, completion guidelines, and user experience in EDC.

18 terms

Instructions describing how sites should populate eCRF fields to ensure consistent data entry across sites and users.

Predefined options that reduce variability compared with free text.

Marking CRF fields with dataset mapping identifiers so collected data can be traced to downstream datasets and variables.

A common eCRF design issue: Ambiguous units. Addressing it reduces downstream queries and rework.

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CRF design principles, annotations, completion guidelines, and user experience in EDC.

18 terms

Instructions describing how sites should populate eCRF fields to ensure consistent data entry across sites and users.

Predefined options that reduce variability compared with free text.

Marking CRF fields with dataset mapping identifiers so collected data can be traced to downstream datasets and variables.

A common eCRF design issue: Ambiguous units. Addressing it reduces downstream queries and rework.

CRF Design Pitfall: Inconsistent response options

A common eCRF design issue: Inconsistent response options. Addressing it reduces downstream queries and rework.

A common eCRF design issue: Missing visit-level context. Addressing it reduces downstream queries and rework.

A common eCRF design issue: No guidance for partial dates. Addressing it reduces downstream queries and rework.

A common eCRF design issue: Overly complex grids. Addressing it reduces downstream queries and rework.

A common eCRF design issue: Overuse of free text fields. Addressing it reduces downstream queries and rework.

A common eCRF design issue: Poor alignment to endpoints. Addressing it reduces downstream queries and rework.

A common eCRF design issue: Redundant fields across forms. Addressing it reduces downstream queries and rework.

A common eCRF design issue: Unclear skip logic. Addressing it reduces downstream queries and rework.

A common eCRF design issue: Unnecessary collection of identifiers. Addressing it reduces downstream queries and rework.

Inline instructions that reduce ambiguous entries and improve consistency.

A free-text fallback that should be constrained and reviewed to avoid overuse.

Conditional behavior that shows or hides fields based on prior answers to reduce unnecessary data entry.

Planned sequence of visits and forms; impacts windows and expected data volume.

Allowed timing range around a visit target date; affects deviations and analyses.