Copyright 2012, SAS Institute Inc. All rights reserved. VISUALIZATION OF STANDARD TLFS FOR CLINICAL TRIAL DATA ANALYSIS
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1 VISUALIZATION OF STANDARD TLFS FOR CLINICAL TRIAL DATA ANALYSIS WENJUN BAO AND JASON CHEN JMP, SAS INC. PHUSE, SHANGHAI, NOV 28, 2014
2 OUTLINES: CDISC Standard SDTM ADaM Interactive Standardized TLFs Tables Lists Figures Conclusion
3 DATA STANDARDIZATION CDISC
4 CDISC: CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM CDISC BDS ADaM SDTM SEND ADSL ADaM: Analysis Data Model o ADSL: Subject-Level Analysis Dataset o BDS: Basic Data Structure SDTM: Study Data Tabulation Model SEND: Standard for Exchange of Nonclinical Data Interventions Class Events Class Findings Class Findings About Special Purpose Domain Trial Design Domain Relationship Datasets EX: Exposures SU: Substance Use CM: Concomitant Medications DS: Disposition CE: Clinical Events AE: Adverse Events MH: Medical History DV: Protocol Deviations VS: Vital Signs EG: ECG; LB: Lab QS: Questionnaires PE: Physical Exams DA: Drug Accountability SC: Subject Characteristics PC/PP: PK Conc/Parameters MB: Microbiology Specimen MS: Microbiology Susceptibility IE: In/Exclusion Criterion Not Met FA: Finding About CO: Comments DM: Demographic SV: Subject Visits SE: Subject Elements TA: Trial Arm TV: Trial Visit TE: Trial Elements TS: Trial Summary TI: Trial In/Exclude Criteria Supplemental Qualifiers RELREC: Related Records
5 BASIC RULES FOR CDISC VARIABLES The Variable Name 8 characters The Variable Label 40 characters The data Type
6 SDTM AND ADAM
7 ADAM: ANALYSIS DATA MODEL CDISC: Clinical Data Interchange Standards Consortium
8 SDTM: STUDY DATA TABULATION MODEL CDISC: Clinical Data Interchange Standards Consortium
9 INTERACTIVE RESULTS TABLES
10 CLASSIC DEMOGRAPHICS TABLE REPORT: FDA Reviewer Guidance 2005
11 MODERN DEMOGRAPHICS TABLE REPORT: SAME
12 MODERN DEMOGRAPHICS TABLE REPORT: NEW
13 INTERACTIVE MODERN DEMOGRAPHICS TABLE REPORT
14 REPORT LISTS: INDIVIDUAL INFORMATION LIST PATIENT PROFILES
15 INTERACTIVE MODERN DEMOGRAPHICS TABLE REPORT
16 INTERACTIVE RESULTS LISTS
17 REPORT LISTS: STANDARDIZED WHAT TO ANALYSIS
18 REPORT LISTS: STANDARDIZED WHAT THE RESULTS ARE
19 REPORT LISTS: INDIVIDUAL INFORMATION LIST PATIENT PROFILES
20 REPORT LISTS: INDIVIDUAL INFORMATION LIST PATIENT AE NARRATIVE
21 INTERACTIVE RESULTS GRAPHICS FOR EVERY REPORTS
22 RISK BASED MONITORING (RBM) 1 Position Paper: Risk-Based Monitoring Methodology. TransCelerate Biopharma Inc, Risk-based Monitoring and fraud detection in clinical trials using JMP and SAS. Richard Zink 2014
23 INTERACTIVE GRAPHICS: RBM RISK INDICATORS: TRAFFIC-LIGHT SYSTEM AT SITE (OR COUNTRY) LEVEL
24 INTERACTIVE GRAPHICS: RBM RISK INDICATORS: SUGGESTION ACTION
25 INTERACTIVE GRAPHICS: RBM RISK INDICATORS: MAPS
26 INTERACTIVE GRAPHICS: FRAUD DETECTION
27 INTERACTIVE GRAPHICS: FRAUD DETECTION HOLIDAYS AND WEEKENDS
28 INTERACTIVE GRAPHICS: ADVERSE EVENTS
29 INTERACTIVE GRAPHICS: ADVERSE EVENTS AE DISTRIBUTION
30 INTERACTIVE GRAPHICS: ADVERSE EVENTS AE INCIDENCE SCREEN BUBBLE PLOT
31 INTERACTIVE GRAPHICS: FINDINGS
32 INTERACTIVE GRAPHICS: FINDINGS HY S LAWS
33 CONCLUSIONS Automation Standardization
34 JMP CLINICAL: CLINICAL TRIAL STUDY SOLUTION Visual Interactive Powerful Analytical
35 Copyright 2010 SAS Institute Inc. All rights reserved.
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