Home
TFL to SAS
Protocol to Trial Domains
Generate ADRG/SDRG
API Docs
Generate ADRG/SDRG
Generate Analysis Data Reviewer's Guide (ADRG) or Statistical Data Reviewer's Guide (SDRG) documents
Study Information
Protocol ID *
Study Title *
Study Phase *
Select Phase
Phase I
Phase II
Phase III
Phase IV
Phase I/II
Phase II/III
Preclinical
Other
Therapeutic Area *
Select Therapeutic Area
Oncology
Cardiology
Neurology
Psychiatry
Endocrinology
Immunology
Infectious Diseases
Respiratory
Gastrointestinal
Dermatology
Ophthalmology
Rare Diseases
Other
Document Type *
Select Document Type
ADRG (Analysis Data Reviewer's Guide)
SDRG (Study Data Reviewer's Guide)
Datasets to Include
Select Datasets to Include in the Reviewer's Guide:
SDTM Domains
DM - Demographics
AE - Adverse Events
CM - Concomitant Medications
EX - Exposure
LB - Laboratory Test Results
VS - Vital Signs
MH - Medical History
PE - Physical Examination
QS - Questionnaires
EG - ECG Test Results
PC - Pharmacokinetics Concentrations
PP - Pharmacokinetics Parameters
ADaM Datasets
ADSL - Subject Level Analysis Dataset
ADAE - Adverse Events Analysis Dataset
ADCM - Concomitant Medications Analysis Dataset
ADEX - Exposure Analysis Dataset
ADLB - Laboratory Analysis Dataset
ADVS - Vital Signs Analysis Dataset
ADEG - ECG Analysis Dataset
ADPC - Pharmacokinetics Concentrations Analysis Dataset
Select All
Clear All
Additional Options
Company/Sponsor Name
Indication
Include standard appendices (Variable specifications, Derivation details)
Include programming implementation notes
Generate ADRG/SDRG Document
About ADRG/SDRG Documents
ADRG (Analysis Data Reviewer's Guide)
Provides comprehensive overview of analysis datasets
Describes data derivation and transformation logic
Documents analysis population definitions
Explains variable creation and imputation methods
SDRG (Study Data Reviewer's Guide)
Focuses on statistical analysis methodology
Documents statistical models and assumptions
Describes handling of missing data
Explains multiplicity adjustments and sensitivity analyses