SDTM, Implementation Guide, and User Guide Updates

Transcription

1 Accenture Life Sciences Rethink Reshape Restructure for better health outcomes. Octagon is Now Part of Accenture SDTM, Implementation Guide, and User Guide Updates Fred Wood July 2013

2 Agenda Model, IG, and User Guide Relationships SDTM-Based Implementation Guides New SDTMIG (3.1.4) Domains Therapeutic-Area User Guides and Domains New SDTM Variables New SDTM Tables CFAST Overview 2013 Accenture All Rights Reserved. 2

3 SDTM, IG, and User Guide Relationship SDTM SDTMIG SENDIG MDIG Alzheimer s UG PKD UG TB UG 2013 Accenture All Rights Reserved. 3

4 A Note on Provisional Standards and Domains A provisional standard (a UG or IG) is one that depends on something else catching up first. New SDTM variables or tables Example is MDIG, which used variables that were not in the SDTM at the time it was issued. Provisional domains are waiting to be packaged into a versioned standard. Domains in User Guides that have not appeared in an IG version. Example is MI domain used in several TA User Guides, but is not in the current SDTMIG. 4

5 SDTM-Based Implementation Guides SDTMIG (Human Clinical Trials) SENDIG (Nonclinical Studies) MDIG (Medical Devices) - v 1.0 Posted as Provisional APIG (Associated Persons) PGxIG (Pharmacogenomics) - Under Development 5

6 New SDTMIG Domains and SDTM Update Batch 1 RP - Reproductive System Findings IS & SR - Immunogenicity Serology and Skin Response EX/EC - Exposure and Exposure as Collected (pending) Batch 2 CV - Cardiovascular (pending) DD - Death Details MI - Microscopic Findings MO - Morphological Findings PR - Procedures (pending) SS - Subject Status TD - Trial Disease Assessments Batch 3 SDTM v1.4 HO - Healthcare Encounters 6

7 Therapeutic-Area User Guides Available Planned Alzheimer s Asthma Polycystic Kidney Disease QT Prolongation Parkinson s Disease Alzheimer s v1.1 (update) Virology Multiple Sclerosis Pain Diabetes Tuberculosis Traumatic Brain Injury Cardiovascular Schizophrenia 7

8 New Domains in User Guides Domain Respiratory Measurements - RE Urinary Findings UR Skin Response Reproductive System Details Subject Status Morphologic Findings Microscopic Findings Death Details User Guide Asthma PKD TB PKD CV, Parkinson s, PKD CV, Parkinson s PKD, TB Parkinson s, TB CV, Parkinson s, PKD 8

9 New SDTM Variables: Interventions Exposure and Exposure as Collected (Pending) --MODE --DOSTKN --PSTRG --PSTRGU --AMDEV --MTHCOL From Findings --LAT Laterality --DIR --PORTOT --FAST Mode Number of Doses Taken Pharmaceutical Strength Pharmaceutical Strength Units Administration Device Method of Collection Directionality Portion or Totality Fasting Status 9

10 New SDTM Variables: Events From Findings --LAT Laterality --DIR Directionality --PORTOT Portion or Totality From Devices --PARTY Accountable Party --PRTYID Identification of Accountable Party --ACNDEV Action Taken with Device 10

11 New SDTM Variables: Findings Microscopic Findings, Tumor Measurements Pharmacogenomics (Pending) --TSTDTL --RFRESV --RFRESX --RUNID --ANMETH Measurement Test or Examination Detail Reference Result Value Reference Result Source Run ID Analysis Method 11

12 New SDTM Variables: Identifiers and Timing Identifiers SPDEVID Sponsor Device Identifier Timing --EVINTX Evaluation Interval Text --STINT Planned Start of Evaluation Interval --ENINT Planned End of Evaluation Interval 12

13 New SDTM Variables: Associated Persons Identifiers (Table 5.1.1) APID RSUBJID RDEVID SREL Associated Persons Identifier Related Subject Related Device Subject, Device, or Study Relationship 13

14 New SDTM Table: Trial Disease Assessments (Table 3.2.4) STUDYID DOMAIN TDORDER TDANCVAR TDSTOFF TDTGTPAI TDMINPAI TDMAXPAI TDNUMRPT Study Identifier Domain Abbreviation Sequence of Planned Assessment Schedule Anchor Variable Name Offset from the Anchor Planned Assessment Interval Planned Assessment Interval Minimum Planned Assessment Interval Maximum Maximum Number of Actual Assessments 14

15 New SDTM Table: RELSUB (Table 4.1.4) STUDYID USUBJID POOLID RSUBJID SREL Study Identifier Unique Subject Identifier Pool Identifier Related Subject or Pool Identifier Subject Relationship 15

16 CFAST: Coalition For Accelerating Standards and Therapies CDISC National Cancer Institute Critical Path Institute FDA National Institutes of Health TransCelerate Biopharma Inc Accenture All Rights Reserved. 16

17 Program Overview July 2013 Therapeutic Area Standards Under Development Slide Courtesy of Rhonda Facile Coordinating Organization(s) Project Manager Stage 0 Stage 1 Stage 2 Stage 3a Stage 3b Stage 3c Scoping & Input Concept Modeling Standards Development Internal Review Public Review Publication Issues Alzheimer's V1.1 Asthma V1 Cardiovascular Endpoints V1 Multiple Sclerosis V1 Diabetes V1 QT Studies V1 CPATH/CDISC Jon Neville CDISC Rhonda Facile DCRI/CDISC Amy Palmer CPATH/CDISC Bess Leroy TCB/CDISC Rachael Zirkle TCB/CDISC John Owen Jan Mar Jun Jul Sep Q313 Jan Mar Jun Jul Sep Q413 Jun Jul Aug Q114 May Aug Jul Q114 Mar Jun Aug Q114 Jul Sep Q214 Traumatic Brain Injury V1 CDISC TBD Aug Q214 Hepatitis C V1 TBD Sep Q314 Schizophrenia V1 DCRI/CDISC Amy Palmer Oct Q314 Oncology TBD Oct Project Status: On target Delayed Critical issues Stage ongoing Stage completed Italics = Projected SAC working to define scope and deliverables. Published Therapeutic Area Standards Alzheimer s Disease V 1 Final Pain V1 Provisional Parkinson s Disease V1 Provisional Polycystic Kidney Disease V1 Provisional Tuberculosis V1 Provisional Virology V1 Provisional 17