The earliest version of the SDTMIG had only one domain for tests on biologic specimens taken from a study subject, the Laboratory Test (LB) domain. SDTMIG v3.4 has 10 domains for specimen-based findings, plus the Biospecimen Events domain.
Use of Fast Healthcare Interoperability Resources (FHIR) in the Generation of Real World Evidence (RWE) demonstrated that electronic CRF data could be populated by mapping FHIR resources to CDASH/SDTM variables. To grow the use of FHIR for eSource beyond pilot projects, existing standards and workflows must be adapted to enable repeatable and scalable processes.
If your data is based on a general observation class, you can determine the answer to this question by consulting the SDTM. Qualifiers for your general observation class, timing variables, and identifiers can generally be added to the dataset.
In all versions of the SDTMIG through v3.2, the "Conformance" section includes the following as a criterion for conformance:
The International System of Units (SI), commonly known as the metric system, is the international standard for measurement. According to the National Institute of Science and Technology (NIST), the SI rests on a foundation of seven defining constants: the cesium hyperfine splitting frequency, the speed of light in vacuum, the Planck constant, the elementary charge (i.e., the charge on a proton), the Boltzmann constant, the Avogadro constant, and the luminous efficacy of a specified monochromatic source.
There is a lot of interest in the clinical trial community to understand what information can be obtained from Electronic Health Records (EHRs) to support clinical trials. The use of FHIR has been endorsed by the Office of National Coordinator for Health Information Technology (ONC) and is widely being used by EHR vendors.
"Sex" and "gender" are similar but different concepts whose definitions and meanings can be confusing (see, for example, the article Sex and gender: What is the difference? from Medical News Today).
When development of the SDTM and SDTMIG started, SAS was in almost universal use in the pharmaceutical industry and at FDA.
In some cases, the reason for the restriction is fairly obvious, but in other cases, understanding the reason requires understanding the differences between how human clinical trials and nonclinical trials are conducted.
In an events or interventions domain, the variable --PRESP = "Y" can be used to indicate that the value in the topic variable (--TERM or --TRT) was pre-specified. However, --PRESP is not a variable that is allowed in findings domains.
This article provides a good example for documenting study subject site transfers, using existing SDTMIG domains and minimal supplemental qualifiers. Originally modeled for COVID studies, this approach could be used any time a study subject change sites during their participation in the study.
This article was written to explain why there are so many Analysis Data Model (ADaM) documents and to help the ADaM user see how they have been designed to work together.
The current Immunogenicity Specimen Assessments (IS) domain in the SDTMIG v3.4 is designed to represent data pertaining to specimen-based assessments that measure the “presence, magnitude and scale of the immune response upon an antigen stimulation or encounter.” Not only does the new domain definition better align with the scientific definition of “immunogenicity”, but it also expands the scope of the IS domain from the previous versions of SDTMIG (i.e., v3.2 and v3.3), where the IS domain was defined to represent data pertaining to “assessments that describe whether a therapy provoked/caused/induced an immune response”.
When the Guidance for Ongoing Studies Disrupted by COVID-19 was being developed, one of the issues was how to represent subject visits, given that regulators wanted to know about visits that were missed or modified due to the pandemic.