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 Grade

Sample 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
Medication 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!