The SDTM Trial Design domains represent the planned treatment paths for a subject in a clinical trial based on the protocol. These trial design domains consist of the following: Trial Arms (TA), Trial Elements (TE), Trial Inclusion/Exclusion (TI), Trial Summary (TS), and Trial Visits (TV).
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What is SDTM and when is it used?
SDTM is also used in non-clinical data ( SEND ), medical devices and pharmacogenomics/genetics studies. SDTM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan). Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions.
What is an sdtmig domain?
The SDTM is a metadata model and SDTMIG domains classified as Interventions, Events, Findings, or Findings About are instantiations of an SDTM general observation class. Key Benefits: Consistent representation of concepts in all domains in the same general observation class
What is the protocol planned dose unit In SDTM?
The protocol planned dose unit is mg/kg and is represented in TS. The CDISC SDTM Exposure Domains (EX & EC) Demystified, continued 3. Example CRF - The CRF collected dose unit is mg. In EC, 15 mg was the collected dose and the pharmaceutical strength was 5 with a unit of mg/capsule.
What SDTM versions are associated with the IGS?
This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, CDASHIG, etc.). Each IG will reference the SDTM version it is associated with. One SDTM version can be referenced by multiple IGs.
What is findings about domain in SDTM?
Findings domains may be represented as findings about a study subject or about an associated person. A findings domain record can be linked to supplemental qualifiers, to comments, or to other records via relationships represented in RELREC.
What is interventions in SDTM?
The Interventions class captures investigational treatments, therapeutic treatments, and surgical procedures that are intentionally administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., “exposure”), coincident with the study assessment period ( ...
What is SE domain in SDTM?
SE is a special purpose SDTM domain containing one record per subject per study element. Its purpose is to describe the study elements that a subject participated in during the study and the dates associated with those elements.
What is Trial element in SDTM?
The SDTM Trial Design domains represent the planned treatment paths for a subject in a clinical trial based on the protocol. These trial design domains consist of the following: Trial Arms (TA), Trial Elements (TE), Trial Inclusion/Exclusion (TI), Trial Summary (TS), and Trial Visits (TV).
What is an intervention domain?
This domain contains: The InterventionPrescription entity, which describes an activity intended to address a specific problem or diagnosis. It identifies the kinds of students targeted and how the intervention should be delivered.
What are clinical events in SDTM?
Clinical Events (CE) The definition of Clinical Events in the SDTM Implementation Guide is ´The intent of the domain model is to capture clinical events of interest that would not be classified as adverse events.
What is element and epoch in SDTM?
An epoch is easy to confuse with an element but is a little less specific, than is an element, on what is happening to the subject. An epoch is similar to an element but is a characteristic of the trial as a whole (not of an arm) and therefore particularly useful in describing blinded studies.
What is epoch variable in SDTM?
What is the EPOCH Variable. The EPOCH variable specifies what phase of the study data corresponds with. Including accurate EPOCH data allows the reviewer to easily determine which phase of the study the observation or the event occurred, as well as the intervention the subject experienced during that phase.
What are core variables in SDTM?
Core variables are a measure of compliance with the specific SDTM-IG domain model. The value of a core variable shows the importance of the variable to the overall domain structure. Variables are divided into 3 categories: Required variables are needed to identify a data record, e.g STUDYID, and USUBJID.
What are clinical trial variables?
A prognostic factor or variable is a patient characteristic that can predict that patient's eventual response to an intervention.
What is clinical trial epoch?
In clinical trials, the interval of time in the planned conduct of a study—the term epoch is intended to replace period, cycle, phase, stage and other temporal terms. An epoch is associated with a purpose (e.g., screening, randomisation, treatment, follow-up), and applies across all arms of the study.
What is TA in clinical trials?
TA Scan is a comprehensive, web-based clinical business intelligence tool that aggregates and analyzes clinically relevant public and private data to facilitate and accelerate data-driven decision-making for all aspects of clinical study planning and implementation through data insights and analytics.
What is SDTM in clinical trials?
The SDTM Trial Design domains represent the planned treatment paths for a subject in a clinical trial based on the protocol. These trial design domains consist of the following: Trial Arms (TA), Trial Elements (TE), Trial Inclusion/Exclusion (TI), Trial Summary (TS), and Trial Visits (TV).
What is the SE domain?
The SE domain is derived from the subject-level general observation class domains based on 1) the Start and End rules in TE, and 2) the Transition and Branching rules (TATRANS and TABRANCH) in the TA domain. The SDTMIG principles state that there are no gaps between Elements, meaning that the start date/time of an Element (SESTDTC) is the same as the end date/time of the previous Element (SEENDTC). The SE domain can be cumbersome to create if the code attempts to account for both the Start Rule and End Rule for each Element. This paper will discuss a streamlined process for deriving SESTDTC and SEENDTC by accounting for only the Start Rule (SESTDTC) for each Element, while including the End Rule (SEENDTC) in the code only if the subject does not fulfill the planned Start Rule of their next Element (e.g., due to study discontinuation, some other unplanned occurrence), or if it is the last Element.
What is Subject Elements domain?
The Subject Elements domain allows the submission of data on the timing of the Elements a subject actually passed through in their participation in the trial. Using the information defined in the TA and TE domains, the actual start date/time (SESTDTC) and end date/time (SEENDTC) that a subject was in a particular Element can be derived from data in the subject-level GOC domains. According to the SDTMIG, since there are no gaps between Elements, the SEENDTC for one Element will always be the same as the SESTDTC for the next Element. This also means that a subject can only be in one Element at a time.
What is the purpose of the FDA SDTCG?
Per the FDA SDTCG (Study Data Technical Conformance Guide), the goal of standardizing data is to make the data more useful and to support semantically interoperable data exchange such that it is commonly understood by all parties.
When was the Exposure domain considered permissible?
In 2005 the Exposure domain was considered permissible to represent study treatment administrations when explicitly collected. Many of us in industry thought if administrations weren’t explicitly collected, perhaps only dispensations and returns were collected and mapped to the DA (Drug Accountability domain), then the EX domain wasn’t necessary or appropriate to be created.
What is EC domain?
The EC (Exposure as Collected) domain was introduced in the CDISC SDTMIG (Study Data Tabulation Model Implementation Guide for Human Clinical Trials) version 3.2 as a means to help sponsors produce a more compliant and usable EX (Exposure) domain . It’s a new concept in the SDTM as it establishes a new rule for related/paired domains, and/or breaks the established principle that a single intervention or event should have a single intervention or event record in the SDTM. The EC domain can loosely be considered part of the audit trail for the EX domain, which is recognized as at least a partially derived domain.
What is TS domain?
The SDTM Trial Summary (TS) domain was updated with new variables and implementation strategies with the publication of the SDTM v1.3/SDTMIG v3.1.3. This was an attempt to make the domain more useful to reviewers and to be machine readable to facilitate data warehousing. The FDA has recently considered TS as being essential to include in a study submission. They have developed tools that check that the TS domain is populated according to the guidance in the SDTMIG and the FDA’s Study Data Technical Conformance Guide (TCG). Despite the advice for implementation, constructing an informative and complete TS domain can be challenging for sponsors in terms of interpreting the guidance and using the correct controlled terminologies. This paper will discuss some of the challenges associated with populating specific TS parameters, and provide some solutions for addressing these challenges.
What is STOPRULE in TS?
The TSPARMCD = ‘STOPRULE’ (Study Stop Rule) is a ‘Required’ parameter in TS for which it is unclear how to populate TSVAL. In NCI CT, ‘STOPRULE’ is defined as the rule, regulation and/or condition that determines the point in time when a clinical trial will be terminated.6 But in the SDTMIG, it is defined simply as the protocol-specified stopping rule. These definitions do not unambiguously state whether this rule applies on the trial level or the subject level. Some sponsors populate TSVAL based on the study discontinuation/withdrawal criteria for a given subject provided in the protocol such as disease progression, lost to follow-up, etc. rather than on the trial stop criteria. Though the NCI definition is much clearer that it is at the study level, it’s possible that this definition is not referenced and the SDTMIG is used instead when TS is being constructed. TSVAL for ‘STOPRULE’ should be populated per the criteria for study termination on the trial level. Examples may include number of events, lack of efficacy, and/or safety across subjects. There is no controlled terminology associated with this TSPARMCD/TSPARM for TSVAL so it should be completed per protocol instructions. If the protocol does not have any study termination rules, then TSVAL can be populated with ‘NONE’. In general, it may be helpful to refer to both the SDTMIG as well as the NCI CT definitions when developing TS.
