an introduction to sdtm trial design model (tdm) - phuse … sde 2013 presentations/an...
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An introduction to SDTM Trial Design Model (TDM)
Matt Zhu24May2013
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Outline
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About SDTM SDTM-TDM basicsExamplesImplementationChallenges
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About SDTM
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The content standard for regulatory submission of case report form data tabulations from clinical research studies.Current versions:
SDTM 1.3 final (16/07/12)SDTMIG 3.1.3 final (16/07/12) Intervention
Events
Finding
Finding aboutSpecial Purpose
Relationship
Trial Design
SDTM
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Trial Design
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What is going to be done in a study?information included in the protocol and protocol amendmentsincluding planned interventions, assessments, analyses, eligibility criteria, visits etc.
Planned sequence of events for the studyProvides ability to compare actual subject progress to the study plan
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Trial Design Model
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The Trial Design Model in the SDTM provides a standardized way to describe those aspects of the planned conduct of a clinical trial shown in the study design diagrams of these examples.
clearly and quickly grasp the design of a clinical trialunderstand the rules for how subjects transition through various periods or phases of the trialcompare the designs of different trialssearch a data warehouse for clinical trials with certain featurescompare planned and actual treatment paths and visits for subjects in a clinical trial.
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Definition
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Follow UpEpoch
Treatment EpochScreen Epoch
Screen
Screen
Follow Up
Follow Up
Treatment AB
A two-arm trial comparing Treatment A with pre-treatment B and Placebo
Placebo
Arm A
Arm P
Columns shown with large rectangles “in back” are epochs.
Rows marked by arrows are arms.
Rectangles with heavy outlines are study cells.
Rectangles within the trial cells are elements.
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Definition
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Element: “a building block that is used to organize activity within the trial.”
It involves administering a planned intervention, which may be treatment or no treatment, during a period of time. Elements for which the planned intervention is "no treatment" would include Elements for screening, wash-out, and follow-up.
Screen
Treatment A
Follow Up
BPlacebo
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Definition
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Arm: “a sequence of epochs (time intervals during which treatment is consistent) defining the course of participation for a subject in a trial.”
a path through the study which describes what activities the subject will be involvedequivalent to a treatment group in a parallel design trial each subject is assigned to an Arm
100 mg
200 mg
Placebo
Trail Arm
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Definition
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Epoch: “an interval of time in the planned conduct of a study during which treatment is constant.” The main purpose of an Epoch is to expose subjects to a treatment, or to prepare for such a treatment period.
Screen Epoch
Treatment Epoch
Follow up Epoch
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Definition
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Study Cell: Since the trial as a whole is divided into Epochs, each planned path through the trial (i.e., each Arm) is divided into pieces, one for each Epoch. Each of these pieces is called a Study Cell.
Combination of Arm and Epoch. Each Study Cell represents an implementation of the purpose of its associated Epoch. For Epochs whose purpose is to expose subjects to treatment, the Study Cells associated with that Epoch expose subjects to particular treatments.
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TDM Domain
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TA
TE
TVTI
TSTDM
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Example 1: Parallel Trial Design
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Trial Design Matrix 1
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Example 2: Crossover Trial Design
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Trial Design Matrix 2
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Example 3: Multiple Branches Trial Design
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Trial Design Matrix 3
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Implementation
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Specifies the requirements for the design of the study and is a requirement in order for the data to flow into the clinical database.Core Contents:
Epoch_and_Start_Events TabTreatment tabEpoch_Tie_Breakers tabBusiness_Rules tab
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Implementation
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epoch and start event function.
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Implementation
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tie-breaker rules
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Implementation
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VALIDATING BUSINESS RULE(1) Import the Setup Specifications by reading in the Epoch_and_Start_Events sheet.(2) Count the total number of distinct epochs listed in the Setup Specification.
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Implementation
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VALIDATING BUSINESS RULE(3) The macro reads in the data from the SE domain and transposes it to make one Subject, one record to include all the Actual Elements for each Subject including.
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Implementation
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VALIDATING BUSINESS RULE(4) Test to see if there are any Subjects existing in other domains, but without any records in the SE domain. If so, there's a mismatched epoch in the tested domain.
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Implementation
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VALIDATING BUSINESS RULE(5) Test to see if there's a tie between epochs which need to follow the metadata setup specification.
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Implementation
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VALIDATING BUSINESS RULE(6) Derive v-epoch, comparing the derivations and self derivations.
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Challenges
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Create TDM datasets (prospective or retrospective?)finding the information needed for an accurate representation of the study.Creating TDM tables can be as much of an art as it is a scienceKeep consistency across domains
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Reference:
CDISC SDTM Implementation Guide (Version 3.1.3)FDA Guidance for Human Clinical Trials Clinical Trials Terminology Version 2.0, CDISC. CDISC Study Design Model in XML (SDM-XML)