ADRG: Analysis Data Reviewer’s Guide

Background Story:

One day, my friend 77 asked me which one is more important ADRG (Analysis Data Reviewer’s Guide) or define.xml? I think define.xml focuses more on the ADaM dataset level, whereas ADRG provides an overview storyline for the study or additional info besides Define.xml. 

I decided to summarize the general format for the ADRG document.

Contents:

  1. Introduction:
    Purpose, Acroyms, Study data standards and Dictionary, Source Data used for Analysis Creations 
  2. Protocol Description: 
    Phase, label, randomized, Primary Endpoint
  3. Analysis Considerations Related to Analysis Datasets:
    Core Variables, Treatment variables, Imputation/Derivation methods,
    Special Analysis Rules
  4. Analysis data Creation and Data Check
    Data dependency: ADSL (ADMH,ADVS)
    Nadir: the lowest value report after baseline, if multiple, pick the earliest
  5. Analysis dataset Descriptions:
    Overview, Individual datasets(ADSL, ADAE, ADEX…)
  6. Data Conformance Summary
    Pinnacle 21 Summary
  7. Submission of programs 
  8. Appendix:
    Last alive date derivation, Region derivation, baseline flag, CTC GradeSample Info

    *Purpose: provide additional info beyond Define.xml and provides Pinnacle 21 findings
    
    *Acronyms:
    CRF: case report form
    ECG electrocardiogram
    OS: Overall survival
    
    *Study Data Standard:
    CTCAE : Version 4.0
    Medicaiton Events dictionary: MedDRA 23.1 / 24 
    SDTM: SDTM Implementation Guide v3.1.3
    
    *Protocol Description:
    Protocol Number, title, version
    Study design schematic Figure, Study period
    
    *Core variables:
    USUBJID STUDYID SITEID SUBJID SAFEFL ENRFL RANDFL TRTA 
    
    *Treatment variables:
    ARM vs TRTP, ARMCD vs TRTA 
    
    *Visit Window:
    Baseline: last assessment on or before treatment.
    C1D1: day 1 to 7...
    
    *Lab baseline flag:
    if two records or the same day, pick the lowest value.
    
    

    Happy studying!

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