1 THEME DATA SHARING WP CDISC Presented by Mary Thiongo & - PowerPoint PPT Presentation

1 THEME DATA SHARING WP CDISC Presented by Mary Thiongo & Harry van Loen 4th ADMIT workshop, ITM Belgium, 30 NOV-4 DEC 2015

Contents 2  CDISC  Introduction  SDTM  1. Introduction  2. Background  3. Objective  4. SDTM concept Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

Contents 3  CDASH  1. Introduction  2. Value of CDASH  3. CDASH Model  4. CDASH Metadata Tables  5. CDASH Implementation  ADMIT – CDISC - considerations Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

CDISC 4  CDISC  Clinical Data Interchange Standards Consortium  Introductional VIDEO  WEBSITE: http://www.cdisc.org Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 5 o 1. Introduction Study Data Tabulation Model :  organize data  facilitate overall data management  improve regulatory review and approval Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 6 o 2. Background Submission FDA Data Domain recognizes Model SDTM 2015 2002 1999 2001 2004 Submission Data Study Data submission SDTM v 1.4 Model (SDM)  Model v1.0 (SDTM)  focus only ‘ safety ’ focus ‘ all study ’ Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 7 o 3. Objective Data submission SDTM datasets and SDTM metadata Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 8 o 4. SDTM Concept 4.1 SDTM documentation: Study Tabulation SDTM Implementation Controlled Terminology Case Report Tabulation Data Model Guide Data Definition Specification (‘ define .’) SDTM dataset(s) SDTM metadata Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 9 4.2 SDTM basics : Observation(s)  correspond to row in dataset (~record (s)) Variable(s)  correspond to column in dataset Domain/Class  group of related observations Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 10  Example data set (AE) : Domain: Adverse Events (AE) Variables Observation (s) Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 11  4.2.1 Domains & Classes  listed in SDTM IG doc v3.1.2 p. 13 GENERAL OBSERVATION CLASSES two character domain code: AE, DM… EVENTS FINDINGS INTER SPECIAL TRIAL RELATIONSHIP VENTIONS CLASS CLASS PURPOSE DESIGN CLASS DOMAINS DOMAINS Adverse Vital Demo Related Trial Con Med Events Signs graphics Records Summary CM AE VS DM RELREC TS Medical Phyical Trial Supplemental Subject History Exam Visits qualifierss Substance use Visits MH PE TV SUPP- - SU SV . . . . . . . . . . . . . . . Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 12  4.2.1 Domains & Classes  listed in SDTM IG doc v3.1.2 p. 13 GENERAL OBSERVATION CLASSES two character domain code: AE, DM… EVENTS FINDINGS INTER SPECIAL TRIAL RELATIONSHIP VENTIONS CLASS CLASS PURPOSE DESIGN CLASS DOMAINS DOMAINS Adverse Vital Demo Related Trial Con Med Events Signs graphics Records Summary CM AE VS DM RELREC TS Medical Phyical Trial Supplemental Subject History Exam Visits qualifierss Substance use Visits MH PE TV SUPP- - SU SV . . . . . . . . . . . . . . . Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 13  4.2.1 Domains & Classes  listed in SDTM IG doc v3.1.2 p. 13 two character domain code: AE, DM… INTER  Following domains/SDTM datasets: VENTIONS CLASS 1. Concomitant medication- CM  Medication prior and during study Con Med CM 2. Substance Use- SU  Substances (alcohol, coffee, smoking..) affecting efficay & safety Substance use SU 3. Exposure-EX  Study treatment (e.g. placebo, . . . investigational products Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 14  4.2.1 Domains & Classes  listed in SDTM IG doc v3.1.2 p. 13 GENERAL OBSERVATION CLASSES two character domain code: AE, DM… EVENTS FINDINGS INTER SPECIAL TRIAL RELATIONSHIP VENTIONS CLASS CLASS PURPOSE DESIGN CLASS DOMAINS DOMAINS Adverse Vital Demo Related Trial Con Med Events Signs graphics Records Summary CM AE VS DM RELREC TS Medical Phyical Trial Supplemental Subject History Exam Visits qualifierss Substance use Visits MH PE TV SUPP- - SU SV . . . . . . . . . . . . . . . Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 15  4.2.1 Domains & Classes  listed in SDTM IG doc v3.1.2 p. 13 two character domain code: AE, DM… EVENTS  Following domains/SDTM datasets: CLASS 1. Adverse Events-AE  Medical events during study Adverse Events 2. Disposition-DS  Protocol milestones (e.g. randomization), AE completion status & reason discontinuation 3. Medical History-MH  Medical events before and at start Medical History of study MH 4. Protocol Deviations-DV  Protocol deviations during study . . . 5. Clinical Events-CE  Medical events during study but not classified as AEs e.g. efficacy endpoints like malaria in study on malaria Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 16  4.2.1 Domains & Classes  listed in SDTM IG doc v3.1.2 p. 13 GENERAL OBSERVATION CLASSES two character domain code: AE, DM… EVENTS FINDINGS INTER SPECIAL TRIAL RELATIONSHIP VENTIONS CLASS CLASS PURPOSE DESIGN CLASS DOMAINS DOMAINS Adverse Vital Demo Related Trial Con Med Events Signs graphics Records Summary CM AE VS DM RELREC TS Medical Phyical Trial Supplemental Subject History Exam Visits qualifierss Substance use Visits MH PE TV SUPP- - SU SV . . . . . . . . . . . . . . . Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 17  4.2.1 Domains & Classes  listed in SDTM IG doc v3.1.2 p. 13 two character domain code: AE, DM… FINDINGS  Following domains/SDTM datasets: CLASS 1. ECG – EG  ECG data Vital Signs 2. Inclusion/Exclusion criteria not met-IE  criteria that are VS not met 3. LAB Test Results – LB  Lab data of study (incl. central Phyical LAB or CRO) Exam 4. Physical Examination-PE  General physical exam data PE 5. Questionnaire-QS  Questionnaire, diary data . . . Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 18  4.2.1 Domains & Classes  listed in SDTM IG doc v3.1.2 p. 13 two character domain code: AE, DM… (cont.) FINDINGS  Following domains/SDTM datasets: CLASS 6. Subject Characteristics – SC  Subject related data not in Vital other domains e.g. subject intials, eye colour,… Signs VS 7. Vital Signs -VS  Blood Pressure, Height, Weight, Pulse,Body temperature & BMI 8. Drugs Accountability – DA  Accountability of study drug : Phyical Exam receipt, dispensing, return, packaging PE 9. Microbiology Specimen-MB  Microorganisms species data, growth status . . . 10. Microbiology Susceptability-MS  Any findings not in MB Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 19  4.2.1 Domains & Classes  listed in SDTM IG doc v3.1.2 p. 13 two character domain code: AE, DM… (cont.) FINDINGS  Following domains/SDTM datasets: CLASS 11. Pharmacokinetic Concentrations – PK  Tissue related data Vital (serum, blood) – concentrations of study drug & metabolites Signs VS 12. Pharmacokinetic Parameters – PP  Parameters on the time~concentration curve Phyical Exam PE 13. Findings About – FA  Findings related to Events and Interventions not represented within Events/Interventions . . . (e.g. AE severity changing over time) Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 20  4.2.1 Domains & Classes  listed in SDTM IG doc v3.1.2 p. 13 GENERAL OBSERVATION CLASSES two character domain code: AE, DM… EVENTS FINDINGS INTER SPECIAL TRIAL RELATIONSHIP VENTIONS CLASS CLASS PURPOSE DESIGN CLASS DOMAINS DOMAINS Adverse Vital Demo Related Trial Con Med Events Signs graphics Records Summary CM AE VS DM RELREC TS Medical Phyical Trial Supplemental Subject History Exam Visits qualifierss Substance use Visits MH PE TV SUPP- - SU SV . . . . . . . . . . . . . . . Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015

SDTM 21  4.2.1 Domains & Classes  listed in SDTM IG doc v3.1.2 p. 13 two character domain code: AE, DM… SPECIAL  Following domains/SDTM datasets: PURPOSE DOMAINS 1. Demographics – DM  Date of birth, Age, Race, Ethnic origin Demo & values of ARM (study treatment) graphics DM 2. Comments - CO  To collect free text from other domains or CRF comments pages 3. Subject Elements – SE  actual timing of the study Subject Visits elements (screening, randomization, Follow up...) SV 4. Subject Visits -SV  actual timing of the subject visits . . . Mary Thiongo & Harry van Loen, 4th ADMIT Workshop, ITM BELGIUM, 30 NOV-4DEC2015