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Data Cleaning & Review | CDM Tool | PharmaBharat Tools

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Medical Coding(24)

Compliance, Privacy & Quality(14)

CRF / eCRF Design(18)

Data Cleaning & Review(22)

Blinded Data Review Data Cleaning Data Listing Endpoint Confirmation Medical Review Listing Missingness Assessment (Practice Note 103)Missingness Assessment (Practice Note 113)Missingness Assessment (Practice Note 123)Missingness Assessment (Practice Note 13)Missingness Assessment (Practice Note 133)Missingness Assessment (Practice Note 143)Missingness Assessment (Practice Note 23)Missingness Assessment (Practice Note 3)Missingness Assessment (Practice Note 33)Missingness Assessment (Practice Note 43)Missingness Assessment (Practice Note 53)Missingness Assessment (Practice Note 63)Missingness Assessment (Practice Note 73)Missingness Assessment (Practice Note 83)Missingness Assessment (Practice Note 93)Outlier Source Data Review

Database Lock & Closeout(37)

EDC Workflow & Data Entry(23)

Edit Checks & Validation(33)

Metrics & Oversight(50)

Other CDM Concepts

Programming Handover(39)

Queries & Discrepancy Management(19)

Reconciliations(7)

Standards (CDISC / Controlled Terms)(21)

Study Setup & Planning(12)

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CDMData Cleaning & Review

Data Cleaning & Review

Listings review, trend checks, data review plans, and escalation of critical issues.

22 terms

Blinded Data Review

Review activities performed while maintaining treatment blind where required.

Systematic identification and resolution of data issues so the dataset is internally consistent and analytically usable.

Tabular view of collected data used to identify trends, outliers, and inconsistencies.

Endpoint Confirmation

Process to confirm primary/secondary endpoint events are captured consistently.

Medical Review Listing

Targeted listing used by medical reviewers to identify clinically relevant inconsistencies.

Missingness Assessment (Practice Note 103)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 113)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 123)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 13)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 133)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 143)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 23)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 3)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 33)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 43)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 53)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 63)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 73)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 83)

Review of missing data patterns to identify systemic issues.

Missingness Assessment (Practice Note 93)

Review of missing data patterns to identify systemic issues.

A value that is unusually high/low relative to expected patterns, requiring verification.

Source Data Review

Review of source to confirm critical information beyond what is entered in EDC.