Scribd Logo
Upload

Welcome to Scribd!

  • 128 views

    4 SDTM AMuraro

    Uploaded by

    Rajashekar Gatla
    The document discusses the Study Data Tabulation Model (SDTM) standard for clinical trial data submission to regulatory authorities. It provides background on FDA guidance for electronic submissions and endorsement of SDTM. Key points covered include the purpose and structure of SDTM domains, variables, controlled terminology, and trial design representation. Examples are given of specific SDTM domains like DM, DS, LB. The document also discusses FDA adoption of SDTM through guidance, proposed rules, and training as well as one company's experience implementing SDTM.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd

    4 SDTM AMuraro

    Uploaded by

    Rajashekar Gatla
    128 views27 pages
    The document discusses the Study Data Tabulation Model (SDTM) standard for clinical trial data submission to regulatory authorities. It provides background on FDA guidance for electronic submissions and endorsement of SDTM. Key points covered include the purpose and structure of SDTM domains, variables, controlled terminology, and trial design representation. Examples are given of specific SDTM domains like DM, DS, LB. The document also discusses FDA adoption of SDTM through guidance, proposed rules, and training as well as one company's experience implementing SDTM.

    Original Description:

    Study Data Tabulation Model (SDTM)

    Original Title

    4_SDTM_AMuraro

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    The document discusses the Study Data Tabulation Model (SDTM) standard for clinical trial data submission to regulatory authorities. It provides background on FDA guidance for electronic submissions and endorsement of SDTM. Key points covered include the purpose and structure of SDTM domains, variables, controlled terminology, and trial design representation. Examples are given of specific SDTM domains like DM, DS, LB. The document also discusses FDA adoption of SDTM through guidance, proposed rules, and training as well as one company's experience implementing SDTM.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    128 views27 pages

    4 SDTM AMuraro

    Uploaded by

    Rajashekar Gatla
    The document discusses the Study Data Tabulation Model (SDTM) standard for clinical trial data submission to regulatory authorities. It provides background on FDA guidance for electronic submissions and endorsement of SDTM. Key points covered include the purpose and structure of SDTM domains, variables, controlled terminology, and trial design representation. Examples are given of specific SDTM domains like DM, DS, LB. The document also discusses FDA adoption of SDTM through guidance, proposed rules, and training as well as one company's experience implementing SDTM.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    You are on page 1of 27

    CDISC Italian User Group 16 November 2007

    Study Data Tabulation Model (SDTM)

    Annamaria Muraro
    Helsinn Healthcare

    Regulatory Background
    1999, FDA guidance Providing Regulatory Submissions in Electronic Format NDAs
    SAS XPT datasets Pdf documents: Define.pdf (data contents), blankcrf.pdf (annotated CRF) Case Report Tabulation (Patient Profiles) as pdf files

    October 2005: FDA issued the guidance Providing Regulatory submissions in Electronic format using the eCTD specifications September 2006: FDA published in the Federal Register a notice of withdrawal of electronic submission guidance for eNDA.
    This notice designates eCTD as preferred format for electronic submissions and notes that beginning Jan 2008 any electronic submission must be eCTD

    What is SDTM: Study Data Tabulation Model


    This model describes the contents and structure of data collected during a clinical trial The purpose is to provide regulatory authority reviewers (FDA) a clear description of the structure, attributes and contents of each dataset and variables submitted as part of a product application
    3

    SDTM
    Animals (SEND)

    Humans (SDTMIG)

    Implementation Guidelines
    http://www.cdisc.org/standards/index.html http://www.fda.gov/oc/datacouncil/cdisc.html

    Study Data Tabulation Model, Version 1.1, April 2005


    which represents the underlying conceptual model behind the submission data standards (SDS)

    SDTM Implementation Guide, Version 3.1.1, August 2005


    Detailed Domains description, Variables to be included and their attributes, assumptions and convention, Examples Version 3.1.2 posted for Comment July 2007
    New standard domains More details

    Controlled Terminology: SDTM Package-1 & Lab Test Controlled Terminology, Package 2A, Package 2B (under development) SEND, Standard for Exchange of Nonclinical Data Implementation Guide for Animal Toxicology Studies, Version 2.3
    4

    Fundamentals of SDTM - Domains


    Domain: collection of observations with common topic Case Report Form SDTM domain Dataset
    A domain may collect data from more than one CRF form Generally each domain is represented by a dataset

    Each domain has a unique two-character domain name (e.g., AE, CM, VS) Variables in domain begin with the domain prefix: (e.g., VSTESTCD) Domain structure: vertical Two categories of domains:
    CDISC Standard Domains (spelled out in detail in the Implementation Guide). Custom Domains
    Based on one of the General Observation Classes (findings, events, interventions) Basic variables are outlined in the SDTM Rules for creating these are in Section 2 of the IG

    SDTM Basics - Structures Based Upon General Observation Classes


    Interventions:
    Investigational treatments, therapeutic treatments, and procedures administered to or taken by the subject One record per constant dosing/treatment interval Examples: study medications(EX), concomitant medications(CM)

    Events:
    Occurrences or incidents independent of planned study evaluations occurring during the trial or prior to the trial One record per event Examples: medical history(MH), adverse events(AE)

    Findings:
    Observations resulting from planned evaluations One record per finding result or measurement Examples: lab data(LB), vital signs(VS)

    Each of these has defined structures and variables. No new variables may be added to these domain classes
    6

    SDTM Basics - Special-Purpose Datasets


    Not Classified as Interventions, Events, or Findings They Have Special Rules Demographics (DM) Comments (CO): free text comments Trial domains: to describe the design of a trial RELREC dataset: represent the relationship between datasets and records SUPPQUAL: used for data items not included in the SDTM standard

    SDTM Standard Domains


    Interventions
    Exposure
    (EX)

    Events
    Adverse Event (AE) Disposition
    (DS)

    Findings
    Labs
    (LB)

    Other
    Demog
    (DM)

    Incl/Excl
    (IE)

    ConMeds
    (CM)

    Vitals
    (VS)

    SubjChar
    (SC)

    Comments
    (CO)

    Supp Qualifiers Subst Use


    (SU)

    MedHist
    (MH)

    PhysExam
    (PE)

    ECG
    (EG)

    Relationships Trial Design

    Deviations
    (DV)

    Questionnaire
    (QS)

    PK Param (PP) Concentrations (PC)


    Draft 3.1.2

    Microbiology (MB)

    Drug Accountability (DA)


    8

    Fundamentals of SDTM - Variables

    CDISC categorizes variables as being


    Required: variables need to be in the domains
    Their values cannot be null Some values may be null

    Expected: variables need to be in the domain Permissible: variables included in the domain as needed

    CDISC

    categorizes variables into five roles

    Identifier: identify the study, subject of the observation, the sequence number Topic: specify the focus of the observation (such as the name of the lab test) Timing: describe the timing of the observation (Visit, Start/End date, Days, Time Points, Duration) Qualifier: additional text or numeric values Rule: express an algorithm or method to define start, end or looping conditions in the Trial Design model

    Fundamentals of SDTM - Variables


    Variables Attributes
    Variable Name: limited to 8-chars Variable Label: <=40 chars Variable Type: mainly char Variable Lenght: <=200 chars

    Date/time format
    ISO 8601 is a text string YYYY-MM-DDT hh:mm:ss (not a SAS format) Has ability to handle incomplete date Example: December 15, 2003 13:14:17 2003-12-15T13:14:17 December 15, 2003 2003-12-15

    Controlled Terms or Format


    Controlled terminology or text should be used instead of, or in addition to arbitrary number codes ( No SAS format!!) CT (**) published externally (ex.MedDRA or follow CDISC-specific terminology) CT (*) value from a sponsor-defined codelist

    Raw data (as originally collected) and derived values (e.g. conversion to standard units, age)
    10

    Example: DM

    CRF Derived Sponsor Defined External Lab

    Required Expected Permissible Details

    YYYY-MM-DDThh:mm:ss

    11

    Example: DM

    Reference standards

    12

    Example: DS

    13

    Example: DS

    DISPOSITION EVENT PROTOCOL MILESTONE OTHER EVENT

    14

    Example (LB)

    ORIGINAL RESULT

    15

    Example (LB)

    STANDARD FORMAT, char

    STANDARD FORMAT, num

    16

    Trial Design Model


    Defines a standard structure for representing the planned sequence of events and the treatment plan for the trial Trial Arms (Planned): described each planned arm in the trial
    (ordered sequence of elements)

    Trial Element (Planned): describes the Element, rules for


    starting/ending the element

    Trial Visits (Planned): describes the planned order and number


    of visits in the study
    tion c e S IG , 7.1 e 87 pag

    17

    Trial Design Model


    Subject Element (Actual), Subject Visit (Actual) Subject Element and Subject Visit are specialpurpose domain in the draft version SDTMIG 3.1.2 Trial Inclusion/Exclusion Criteria: lookup table: one record for
    each inclusion/exclusion criterion. Not subject oriented

    Trial Summary: descriptive attributes of trial like trial phase, title, objective etc.)

    18

    SDTM adoption by FDA


    July 2004: FDA has endorsed the CDISC standards

    October 2005, FDA Guidance for ICH eCommon Technical Document (eCTD) is updated. CDISC SDTM format is recommended for clinical data and define.xml for metadata

    19

    Dec 2006: Proposed Rule


    The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments be provided in an electronic format that FDA can process, review, and archive. The proposal would also require the use of standardized data structure, terminology, and code sets contained in current FDA guidance (the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium) to allow for more efficient and comprehensive data review.

    Federal Federal Register Register // Volume Volume 71, 71, No. No. 237 237 // Monday, Monday, December December 11, 11, 2006 2006

    The CDISC SDTM is still the preferred data specification. It will become required data specification when the proposed rule is approved.
    20

    FDA standard tools


    Data standards allow FDA to develop standard tools for review (http://www.fda.gov/oc/datacouncil/meetings/oliva.pdf)
    WebSDM was developed under a Cooperative Research and Development Agreement (CRADA) between the FDA and Lincoln Technologies with the goal of providing a user-friendly environment for browsing and reviewing CDISC SDTM-compliant clinical trial. This product has been in use at FDA since 2004 For each domain, users can access variable summary statistics, data visualization tools and drill down into individual subject data and patient profiles

    21

    SDTM Adoption by FDA


    SDTM / ADaM Pilot projects
    Pilot regulatory submission using SDTM/ADaM (data from Eli Lilly company, lesson learned reported at CDISC Interchange 2006) Integrated Safety Data Pilot is now underway

    CDISC SDTM Training at FDA: In preparation for the


    increasing volume in SDTM submissions to the FDA, CDISC and FDA have joined forces to ensure that FDA personnel, "speak SDTM". On 9 July 2007, there was an open SDTM training session for FDA at the White Oak facility in Maryland. Approximately 50 people from FDA attended with representation from statistical, data management, and programming functions (CDISC newsletter,

    Sept 2007)

    22

    Implementation: Helsinn experience


    Integrated approach to standardization Team work and training Standards applied to any study, any phase Mapping to CDISC standards
    CDISC general assumptions 100% implemented Include any Required and Expected variables Select Permissible variables based on data we collect Some deviations from CDISC acceptable Need to develop code lists (lab parameter, pk parameters, etc.), CDISC controlled terminology not available yet Clear understanding of the SDTMIG Are custom domains needed? Where to collect cancer history? How to map data collected by patient diary? Coding for CM, intermediate levels were needed Trial domains mapping for cycle based studies, cross-over studies

    Interacting with CROs and providers


    Provide CROs with a clear understanding of CDISC mapping requirements Central Lab, Bioanalytical provider: collect data CDISC compliant from the source

    Integration of old clinical data


    23

    Should SDTM be used for submissions to the FDA only?


    Benefit of SDTM as internal data standard
    No need to convert data for esubmission Reduce data transformation efforts Efficient (and coste effective) data exchange with providers (CROs, Central Lab, etc) Easier interaction with CROs, in-licensing made easier, mergers less painful To maximize clarity in the process using a data standard which everyone will be familiar: integrated process from CRF to submission To use standards with large consensus with pharma industry instead of maintain its own standard

    But dont expect it to be easy! Expect resistance e.g. whats wrong with my existing standard, we dont have time/resource Have answers ready for questions such as How long will it take? How much resource will be required? What is the cost of doing this? What are the cost savings if we implement this?
    24

    Questions

    25

    Representing Relationship Back-up


    Relating groups of records in a domain for a subject
    Use the variable --GRPID

    Relating non-standard variables to a parent domain


    SDTM does not allow the addition of new variables Use the SUPPQUAL dataset to capture non-standard variables and their association to parent records Suppl variables may be collected by separete SUPP dataset (convention SUPP where is the two letter domain code (example SUPPLB, SUPPDM)

    Relating independent records in separate domains


    Use the RELREC dataset

    Relating datasets
    Use the RELREC dataset

    , 8.1 . r pa IG, e 121 pag

    26

    Creating a New Domain: BACK-UP slide


    Ensure that there is a definite need to create a new domain Assign a 2-letter domain code Choose the general observation class (Interventions, Events or Findings) that best fits the data Add variables as follow: Identifier Variables (studyid, domain, usubjid, --seq), Timing Variables, Topic & Qualifiers No new sponsor-defined variables can be added to SDTM Follow SDTM conventions for variable order, name/label/type

    , 2.6 . r pa IG, e 13 pag

    27

    You might also like

    pFad - Phonifier reborn

    Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

    Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


    Alternative Proxies:

    Alternative Proxy

    pFad Proxy

    pFad v3 Proxy

    pFad v4 Proxy