The SDTMIG: What s New in 3.2

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1 Accenture Life Sciences Rethink Reshape Restructure for better health outcomes. The SDTMIG: What s New in 3.2 Fred Wood Data Standards Consulting Lead Accenture Life Sciences RTP CDISC User Network March 6, Agenda Model, IG, and User Guide Relationships SDTMIG v3.2 Overview New Domains SDTM v1.4 New SDTM Variables New SDTM Tables New Domain Tour SDTM Based Implementation Guides CFAST Overview Therapeutic Area User Guides and Domains Looking Forward 1

SDTM, IG, and User Guide Relationships The Model SDTM Implementation Guides SENDIG SDTMIG Implementation Guide Supplements SDTMIG-MD SDTMIG-PGx SDTMIG-AP User

2 SDTM, IG, and User Guide Relationships The Model SDTM Implementation Guides SENDIG SDTMIG Implementation Guide Supplements SDTMIG-MD SDTMIG-PGx SDTMIG-AP User Guides TAUGs Therapeutic-Area Collaboration CDISC National Cancer Institute Critical Path Institute FDA National Institutes of Health TransCelerate Biopharma Inc. 4 2

3 TransCelerate Member Companies Founding Members Additional Members Abbvie Allergan AstraZeneca Astellas Boehringer Ingelheim Biogen Idec Bristol Meyers Squibb Braeburn Pharmaceuticals\ Lilly Cubist Pharmaceuticals GlaxoSmithKline EMD Serono, Inc Johnson & Johnson Forest Laboratories Pfizer Medgenics Roche Onyx Pharmaceuticals Sanofi Shionogi UCB Accenture providing project management and SMEs 5 Therapeutic-Area User Guides Available Alzheimer's Disease v2 Provisional Alzheimer's Disease v1 Final Asthma v1 Provisional Pain v1 Provisional Parkinson's Disease v1 Provisional Polycystic Kidney Disease v1 Provisional Tuberculosis v1 Provisional Virology v1 Provisional Planned Late Stage Diabetes Multiple Sclerosis Cardiovascular Early Stage QT Prolongation Traumatic Brain Injury Hepatitis C Schizophrenia 6 3

4 A Note on Provisional Standards and Domains In general, when anything CDISC publishes (after going through all the necessary reviews) is dependent upon something else being published, it s provisional. For example: Implementations guides are published as provisional when some of the tables have not yet appeared in an SDTM version. Such was the case for the first versions of the APIG and MDIG. User Guides are provisional when domains are not in an IG or variables are not in the SDTM. The first versions of the TAUGs for Asthma and Diabetes are examples. In general, any domains where CT has yet been fully developed are also provisional. 7 New Domains in User Guides Domain Respiratory Measurements RE Study Agents (AG) Urinary Findings UR Skin Response Reproductive System Details Subject Status Morphologic Findings Microscopic Findings Death Details User Guide Asthma Asthma PKD TB PKD CV, Parkinson s, PKD CV, Parkinson s PKD, TB Parkinson s, TB CV, Parkinson s, PKD 8 4

Variables Provisional Domain(s) SDTM Update Final TAUG?

5 Typical Domain-Development Flow Today TA Scoping TA CRFs TA CDASH Questions TA SDTM Based Domains New SDTM Variables Provisional Domain(s) SDTM Update Final TAUG? SDTMIG Update Provisional TAUGs CT Update 9 Portfolio Structure (1) 10 5

Portfolio Structure (2) 11 New SDTM Domains

Events HO Healthcare Encounters Findings About SR Skin

Findings DD Death Details IS Immunogenicity Specimen

Findings RP Reproductive System Findings SS Subject

6 Portfolio Structure (2) 11 New SDTM Domains Interventions EC Exposure as Collected PR Procedures Events HO Healthcare Encounters Findings About SR Skin Response Trial Level Data TD Trial Disease Assessments Findings DD Death Details IS Immunogenicity Specimen Assessment MI Microscopic Findings MO Morphological Findings RP Reproductive System Findings SS Subject Status TU Tumor Identification TR Tumor Results RS Disease Response 12 6

Fasting Status Scheduled Performed 13 New SDTM Variables: Events From Findings --LAT Laterality --DIR Directionality --PORTOT

7 New SDTM Variables: Interventions Exposure and --MOOD Mood Exposure as --PSTRG Pharmaceutical Strength Collected (Pending) --PSTRGU Pharmaceutical Strength Units From Findings --LAT Laterality --DIR Directionality Scheduled --PORTOT Portion or Totality --FAST Fasting Status Scheduled Performed 13 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 14 7

8 New SDTM Variables: Findings Microscopic Findings, Tumor Measurements --TSTDTL Measurement Test or Examination Detail Pharmacogenomics --RUNID Run ID --ANMETH Analysis Method - Analysis method applied to obtain a summarized result. PK --ULOQ Upper Limit of Quantitation 15 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 16 8

9 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 17 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 18 9

10 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 19 Exposure as Collected (EC) The Exposure as Collected domain model reflects protocol specified study treatment administrations, as collected. Blinded data collection (tablets vs. mg in EX) Open label studies where protocol specified dosing data has been collected (e.g., 5 ml vs. 3 mg/kg in EX)

11 Procedures (PR) Details describing details (largely timing) of a subject s therapeutic and diagnostic procedures. Examples include the following: Endoscopic examinations Diagnostic procedures Therapeutic procedures Surgical procedures Only needed if the details of the procedure itself are of interest, and are collected. Measurements obtained from procedures are to be represented in their respective Findings domain(s) Healthcare Encounters (HO) The Healthcare Encounters dataset includes inpatient and outpatient healthcare events: Hospitalizations Doctor visits Nursing home and rehabilitation facility stays 22 11

12 Death Details (DD) Details collected about a death: Primary and secondary causes Location (e.g., hospital, home) Was it witnessed? 23 Immunogenicity Specimen Assessment (IS) Only for assessments that describe whether a therapy provoked, caused, or induced an immune response (e.g., vaccines). Viral Antibodies May include sequelae (e.g., viral DNA) Not for overall Immunological assessments (e.g., IgE, IgG) that get submitted in LB 24 12

13 Microscopic Findings (MI) Findings from the microscopic examination of tissue samples. One record per finding Examples include color based (e.g., H&E) and immunohistochemical staining of slides Examinations of cells in fluid specimens such as blood or urine remain classified as lab tests, and should be stored in the LB domain 25 Morphology (MO) Macroscopic observations and measurements of organs and tissues. Size(absolute and relative) Color Shape Methods include: Naked eye Imaging Endoscopy Information about the procedure may or may not be collected in PR. MO is not intended for use in studies in which lesions or tumors are of primary interest and are identified and tracked throughout the study

14 Reproductive System Findings (RP) Reproductive information about a subject. Reproductive ability/status Reproductive history Number of previous pregnancies Number of births Medications related to reproduction should still be included in CM. 27 Subject Status (SS) Data relating to general subject characteristics that are evaluated periodically A common use case is survival information Not intended for data that belong in another domain. It is not for recording clinical test results, event terms, treatment names or other data that belong elsewhere

15 Skin Response (SR) Used to submit dermal responses to antigens. The method of assessment is typically a skin prick test. The first implementation of the Findings About model that uses a twoletter domain that s not FA. Because a subject is typically exposed to many test materials at the same time, SROBJ is needed to represent the test material for each response record. Uses so far have been for allergenicity testing kits and Mantoux (TB) tests. 29 Trial Disease Assessments (TD) Represents the planned schedule of efficacy assessments related to the disease under study. Use case has been with Oncology domains. Can be used for comparison with the actual occurrence of the efficacy assessments in order to determine whether there was good compliance with the schedule

16 SDTM-Based Implementation Guides SDTMIG(Human Clinical Trials) SENDIG(Nonclinical Studies) SDTMIG MD (Medical Devices) v 1.0 Posted as Provisional SDTMIG AP (Associated Persons) SDTMIG PGx (Pharmacogenomics) Under Development Questionnaire Supplements 31 CDISC Questionnaire Supplements(1) 32 16

17 CDISC Questionnaire Supplements(2) 33 The SDTMIG-AP Document Intended as a supplement to the SDTMIG. For data collected about persons other than the subject in a study, who could be associated with the study, a particular study subject, or a device used in the study. Structure mimics that of SDTM but applies the two letter prefix AP at the beginning of all Associated Persons domains, followed by the two letter domain code. An additional dataset (APRELSUB) documents the relationships of associated persons to subjects or devices. Example use cases given: Family History Caregiver Donor Information Sexual Partners Device Operator Injury 34 17

18 Associated Persons Domains Associated Persons Data Special Purpose Domains General Observation Class Domains (Standard Variables) (Non-Standard Variables) APDM (Associated Persons Demographics) APFA-- (Associated Persons Findings About) APAE (Associated Persons Adverse Events) APMH (Associated Persons Medical History) APEX (Associated Persons Exposure**) SQAPFA-- SQAPAE SQAPMH SQAPEX APRELSUB (Documents relations to study subjects, as applicable) RELREC (Related observations, stored in separate datasets. are identified and linked) Slide Courtesy of Gary Walker 35 SDTMIG-MD Document Intended as a supplement to the SDTM Information about entities other than the study subject or the trial itself. For studies with implantable, diagnostic, and imaging devices

19 SDTMIG-MD Domains Special Purpose Domains Device Identifiers DI Device Subject Relationships DR Interventions General Observation Class Device Exposure DX Events General Observation Class Device Events DE Device Tracking DT Findings General Observation Class Device In Use DU Device Properties DO 37 Plans for 2014 (SDTMIG v3.3)(1) Findings NEC Asthma Respiratory System Findings (RE) Procedure Agents (AG) MS Functional Test (FT) Nervous System (NV) CV Lesion Results (LR) Lesion Identification (LI) MS Ophthalmology (OE) under development Interventions Meal Data (ML) Special Purpose or TBD Diabetes Trial Disease Milestones (TM) under discussion Subject Milestones (SM) under discussion FA? CV Clinical Decisions (CD) 38 19

20 Plans for 2014 (SDTMIG v3.3)(2) BRIDG Mappings Classes and Attributes Overloaded Variables METHOD What kind of method? LOC Part of the test or part of the result? Multiple Dates Clinical Events: FA or CE? 39 20

The Evolution of SDTM What s new

Paper CD10 The Evolution of SDTM What s new Tina Apers, Business & Decision Life Sciences, Brussels, Belgium ABSTRACT In July 2012 CDISC released the final version of SDTM V1.3 and SDTMIG V3.1.3. This