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.
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
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.