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Programming Handover

Data exports, transfer specs, derivations, and collaboration with programming/statistics.

39 terms

Baseline Definition (Practice Note 109)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 119)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 129)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 139)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 149)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 19)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 29)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 39)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 49)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 59)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 69)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 79)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 89)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 9)

Rule defining which measurement counts as baseline for analysis.

Baseline Definition (Practice Note 99)

Rule defining which measurement counts as baseline for analysis.

Checksum

A computed value used to verify file integrity after transfer.

Data Definition Document

Reference describing variables, coding, units, and conventions in delivered data.

Data Transfer

Movement of data from EDC/vendor systems to programming environments in agreed formats.

Data Transfer Specification

Defines export structure, variable definitions, formats, and delivery cadence.

Derivation Specification

Document describing how derived variables are calculated and validated.

Exposure Data

Information about dosing administration used for safety and efficacy interpretation.

File Naming Convention

Standard naming for exports to reduce confusion and support automation.

Final Data Delivery

Controlled handover of locked datasets, specs, and documentation to programming/statistics.

SDTM Mapping Consideration

Design choices that affect ease and accuracy of SDTM mapping downstream.

Timepoint Mapping (Practice Note 10)