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Edit Checks & Validation | CDM Tool | PharmaBharat Tools

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Conditional Required Consistency Check Cross-Form Check Derivation Edit Check Edit Check Pattern: Baseline vs post-baseline comparison rule Edit Check Pattern: Conditional required rule Edit Check Pattern: Cross-visit consistency rule Edit Check Pattern: Date sequencing rule Edit Check Pattern: Duplicate entry detection rule Edit Check Pattern: Logical consistency rule Edit Check Pattern: Missingness threshold rule Edit Check Pattern: Protocol window rule Edit Check Pattern: Range by demographic rule Edit Check Pattern: Unit/format validation rule Hard Check Protocol Window Derivation (Practice Note 108)Protocol Window Derivation (Practice Note 118)Protocol Window Derivation (Practice Note 128)Protocol Window Derivation (Practice Note 138)Protocol Window Derivation (Practice Note 148)Protocol Window Derivation (Practice Note 18)Protocol Window Derivation (Practice Note 28)Protocol Window Derivation (Practice Note 38)Protocol Window Derivation (Practice Note 48)Protocol Window Derivation (Practice Note 58)Protocol Window Derivation (Practice Note 68)Protocol Window Derivation (Practice Note 78)Protocol Window Derivation (Practice Note 8)Protocol Window Derivation (Practice Note 88)Protocol Window Derivation (Practice Note 98)Range Check Soft Check

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CDMEdit Checks & Validation

Edit Checks & Validation

Hard/soft checks, cross-form checks, derivations, and validation strategy.

33 terms

Conditional Required

A field required only when certain conditions are met (e.g., if 'Yes', specify).

Consistency Check

Validation that related fields do not contradict (e.g., sex vs pregnancy).

Cross-Form Check

Validation comparing values across different forms (e.g., AE vs Conmed dates).

Calculation of a value from other values (e.g., BMI from height and weight).

Edit Check

A validation rule that flags data that are missing, out of range, or logically inconsistent.

Edit Check Pattern: Baseline vs post-baseline comparison rule

A reusable validation approach: Baseline vs post-baseline comparison rule. Helps detect inconsistencies early and consistently.

Edit Check Pattern: Conditional required rule

A reusable validation approach: Conditional required rule. Helps detect inconsistencies early and consistently.

Edit Check Pattern: Cross-visit consistency rule

A reusable validation approach: Cross-visit consistency rule. Helps detect inconsistencies early and consistently.

Edit Check Pattern: Date sequencing rule

A reusable validation approach: Date sequencing rule. Helps detect inconsistencies early and consistently.

Edit Check Pattern: Duplicate entry detection rule

A reusable validation approach: Duplicate entry detection rule. Helps detect inconsistencies early and consistently.

Edit Check Pattern: Logical consistency rule

A reusable validation approach: Logical consistency rule. Helps detect inconsistencies early and consistently.

Edit Check Pattern: Missingness threshold rule

A reusable validation approach: Missingness threshold rule. Helps detect inconsistencies early and consistently.

Edit Check Pattern: Protocol window rule

A reusable validation approach: Protocol window rule. Helps detect inconsistencies early and consistently.

Edit Check Pattern: Range by demographic rule

A reusable validation approach: Range by demographic rule. Helps detect inconsistencies early and consistently.

Edit Check Pattern: Unit/format validation rule

A reusable validation approach: Unit/format validation rule. Helps detect inconsistencies early and consistently.

A validation rule that prevents saving data until the issue is resolved.

Protocol Window Derivation (Practice Note 108)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 118)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 128)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 138)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 148)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 18)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 28)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 38)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 48)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 58)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 68)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 78)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 8)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 88)

Derived flags indicating whether visits occurred within protocol windows.

Protocol Window Derivation (Practice Note 98)

Derived flags indicating whether visits occurred within protocol windows.

Validation that numeric values fall within plausible or protocol-defined limits.

A validation rule that allows saving but warns or generates a query for review.