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SDTM Data Inconsistencies Cleaning Guide

The SDTM Data Inconsistencies and Cleaning Guide outlines common data issues across various domains such as demographics, adverse events, lab results, and more, along with suggested SAS logic for resolution. Key inconsistencies include incorrect age calculations, missing dates, and unit inconsistencies. The guide emphasizes the importance of real-time data issue identification and fixing, combined with validation processes for accurate submissions.

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64 views1 page

SDTM Data Inconsistencies Cleaning Guide

The SDTM Data Inconsistencies and Cleaning Guide outlines common data issues across various domains such as demographics, adverse events, lab results, and more, along with suggested SAS logic for resolution. Key inconsistencies include incorrect age calculations, missing dates, and unit inconsistencies. The guide emphasizes the importance of real-time data issue identification and fixing, combined with validation processes for accurate submissions.

Uploaded by

munny000
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

SDTM Data Inconsistencies and Cleaning Guide

Domain Common Inconsistencies How to Fix (SAS Logic)

AGE = intck('year', input(BRTHDTC,yymmdd10.), input(RFSTDTC,yy


DM (Demographics)
Incorrect AGE, missing RFSTDTC/RFENDTC Validate RFSTDTC ≤ RFENDTC

if input(AEENDTC,yymmdd10.) < input(AESTDTC,yymmdd10.) then


AE (Adverse Events)
AEENDTC < AESTDTC, missing AEOUT, AESEV Check AEOUT, derive AETRTEM

LBSTRESN = LBORRES * conversion_factor;


LB (Lab Results) LBSTRESN missing, unit inconsistency, abnormal Use
flagsformats
incorrect
to normalize units

VS (Vital Signs) Mixed units (°F/°C), implausible values, missing VSSTAT


Convert all to °C, validate values: if SYSBP > 250 then flag='Check'

CM (ConcomitantCMENDTC
Meds) < CMSTDTC, duplicates, missing indication
Standardize CMTRT; if CMENDTC < CMSTDTC then CMENDTC = C

SU (Substance Use)
Duplicate SUTRT, inconsistent frequency Remove duplicates, standardize SUFREQ using upcase/compress

MH (Medical History)
Uncoded MHTERM, date outside study period Flag records outside RFSTDTC–RFENDTC, apply MedDRA dictiona

CE (Clinical Events)
Missing CEDECOD, incorrect date order Apply dictionary coding, ensure CESTDTC ≤ CEENDTC

DS (Disposition) Invalid DSTERM or DSDECOD, DSSTDTC > RFENDTC


Map DSDECOD to standard terms, validate dates

Use this guide to identify and fix real-time data issues in your SDTM mapping. Combine it with P21
validation and protocol-level cross-checks for accurate submission.

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