Clinical SAS Project (CDISC/SDTM/ADaM/TLF)

Module 1: INTRODUCTION

• INTRODUCTION ABOUT THE COURSE
• INTRODUCTION ABOUT EACH DEPARTMENT (CLINICAL OPERATIONS, CDM, BIO-STATISTICS, MEDICAL WRITING)
• DETAILED INFORMATION ABOUT BIO-STATISTICS (STATISTICIAN, STATISTICAL PROGRAMMERS, SAS PROGRAMMERS)
• INTRODUCTION ABOUT CLIENT, REGULATORY BODIES, SUBMISSION OF THE STUDY
• INTRODUCTION TO SPECIFICATIONS

Module 2: CDISC – SDTM

• INTRODUCTION OF CDISC
• WHY CDISC AND DATA STANDARDS
• VERSIONS OF CDISC
• IMPACT OF CDISC STANDARDS ON CLINICAL ACTIVITIES
• CDISC MODELS
• – STUDY DATA TABULATION MODEL (SDTM)
• – ANALYSIS DATASET MODELS (ADaM)
• – OPERATIONAL DATA MODEL (ODM)
• FUNDAMENTALS OF SDTM
• – WHAT IS SDTM?
• – OBSERVATIONS AND VARIABLES IN SDTM
• – SPECIAL PURPOSE DATASETS
• – GENERAL OBSERVATION CLASSES IN SDTM
• – SDTM STANDARD DOMAIN MODELS
• – GENERAL ASSUMPTIONS FOR ALL DOMAINS
• MODELS FOR SPECIAL PURPOSE DOMAINS
• – DM, CO, SE, SV
• DOMAIN MODELS BASED ON GENERAL OBSERVATION CLASSES
• – INTERVENTIONS (CM, EX, EC, SU)
• – EVENTS (AE, DS, MH, DV, CE)
• – FINDINGS (LB, EG, VS, PE, IE, DD, DA)
• – TRIAL DESIGN DOMAINS (TA, TE, TS, TI, TV)
• SUPPLEMENTAL QUALIFIERS
• SDTM MAPPING PROGRAMMING USING SAS
• SDTM ANNOTATION ON CRF
• SDTM MAPPING SPECIFICATIONS
• REAL TIME PROJECT ON SDTM

Module 3: CDISC – ADaM

• INTRODUCTION TO ADaM
• WHY ADaM
• KEY CONCEPTS
• ADaM IMPLEMENTATION
• FUNDAMENTALS OF THE ADaM STANDARDS
• VARIABLES IN GENERAL
• – ADSL VARIABLES
• – BDS VARIABLES
• – OCCDS VARIABLES
• REAL TIME PROJECT ON ADaM
• – ADSL, ADAE, ADCM, ADLB, ADVS ETC.

Module 4: TLFs (TABLES, LISTINGS, FIGURES)

• INTRODUCTION TO CLINICAL TRIAL
• SUMMARY REPORTS (TABLES, LISTINGS, FIGURES)
• INTRODUCTION TO ICH E6, E9, E3
• PROTOCOL
• CRF / eCRF
• SAP
• MOCK SHELLS
• INTRODUCTION TO STATISTICAL REPORTS
• INTRODUCTION TO CLINICAL STUDY REPORT (CSR)
• SAS PROGRAMS DEVELOPMENT AND VALIDATION (QC)
• MeDRA GUIDELINES
• GENERATING SUMMARY REPORTS
• GENERATING LISTINGS
• GENERATING GRAPHS
• REAL TIME PROJECT ON PHASE II CLINICAL TRIAL STUDIES (ONCOLOGY & DIABETES THERAPEUTIC AREA)

Module 5: DEFINE.XML

• INTRODUCTION TO DEFINE.XML
• INTRODUCTION TO OPEN CDISC

Module 6: PINNACLE 21

• HOW TO USE P21 TOOL
• HOW TO CHECK AND RESOLVE P21 ISSUE

Module 7: SUBMISSION DOCUMENTS

• SDRG (STUDY DATA REVIEWER’S GUIDE)
• ADRG (ANALYSIS DATA REVIEWER’S GUIDE)