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: -Introduction: Purpose, Acroyms, Study data standards and Dictionary, Source Data used for Analysis Creations 

  • Protocol Description:  Phase, label, randomized, Primary Endpoint

  • Analysis Considerations Related to Analysis Datasets: Core Variables, Treatment variables, Imputation/Derivation methods,

-Special Analysis Rules Analysis data Creation and Data Check

  • Data dependency: ADSL (ADMH,ADVS)

  • Nadir: the lowest value report after baseline, if multiple, pick the earliest

  • Analysis dataset Descriptions: Overview, Individual datasets(ADSL, ADAE, ADEX…) Data Conformance Summary Pinnacle 21 Summary Submission of programs 

  • 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!