EDC Workflow & Data Entry

Data entry, roles, audit trail, freezes, user management, and workflow states.

23 terms

Audit Trail

A secure record of who changed data, what changed, when it changed, and often why it changed, supporting traceability.

Data Entry Convention (Practice Note 1)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 101)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 11)

Agreed rules for formatting and recording values to reduce ambiguity.

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EDC Workflow & Data Entry

Data entry, roles, audit trail, freezes, user management, and workflow states.

23 terms

Audit Trail

A secure record of who changed data, what changed, when it changed, and often why it changed, supporting traceability.

Data Entry Convention (Practice Note 1)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 101)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 11)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 111)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 121)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 131)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 141)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 21)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 31)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 41)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 51)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 61)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 71)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 81)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Convention (Practice Note 91)

Agreed rules for formatting and recording values to reduce ambiguity.

Data Entry Lag

Delay between visit and entry; a risk indicator for recall/transcription errors.

Data Entry Status

EDC state indicating if a form is incomplete, complete, signed, frozen, or locked.

Electronic Data Capture(EDC)

A system used to capture and manage clinical trial data electronically, typically via web-based eCRFs with roles and audit trails.

Electronic Signature

Controlled sign-off action with identity and meaning, recorded with audit trail.

Randomization Number

Unique identifier associated with treatment assignment in randomized studies.

Reason for Change

Required explanation for changes to previously saved data to support traceability.

Role-Based Access Control

Permissions model restricting actions (edit, sign, lock) by user role.