Pre-specified Events Collection of adverse event, clinical events, and medical history events can follow two approaches: Were there any events? If yes, what were the events? Did event X occur? If yes, record the details of the event(s)
ADaM datasets include names that start with "AD", therefore "AD" must not be used as the name of a custom SDTM domain. Analysis datasets that are not based on ADaM may have names that start with "AX", so "AX" must not be used as the name of a custom SDTM domain. The SDTM Domain Abbreviations codelist includes "AD" and "AX" as a reminder that these domain abbreviations must not be used for SDTM custom domains.
This diagram illustrates the steps that go into assessing the causality of an adverse event. For certain kinds of adverse events, some steps are almost automatic (e.g., an infectious disease can't happen without a pathogen), but for other kinds of adverse events, there may be many possible causes, and the steps can be quite distinct.
The BRIDG model makes a distinction between a study subject and an experimental unit. In most studies for which SDTM is implemented, these terms refer to the same person or animal, but there are studies where the study subject is different from the experimental unit. For those studies, it can be useful to understand these subtly different terms.
For an implementer trying to decide where data belong in SDTM-based datasets, it's pretty clear when data belongs in a trial design dataset, a relationship dataset, one of the new study reference datasets, or one of the special purpose domains. However, it can be difficult to choose the right general observation class dataset, especially if data are about findings.
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.
In the diagrams below, the red line represents a graph of severity over time for a hypothetical event. For most adverse events, severity cannot be measured on a continuous scale; this line represents hypothetical actual severity, not data that could be recorded. The horizontal lines divide severity into the three categories, "Mild", "Moderate", and "Severe", which are used to describe adverse event severity.
In two previous papers, the PhUSE working group "Investigating the Use of FHIR in Clinical Research" demonstrated that data typically collected in diabetes studies can be extracted from medical records through FHIR (Fast Healthcare Interoperability Resources) and we can automate the process to populate eCRFs (electronic Case Report Forms). These data were then converted to SDTM (Study Data Tabulation Model) which would serve as the source for analysis datasets.
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.
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.
Unified Code for Units of Measure (UCUM) was developed by Regenstrief Institute and the UCUM Organization as an unambiguous system of units and their combinations. UCUM is intended to include all units of measure currently used internationally in science, engineering and business and has been adopted internationally by IEEE, DICOM, LOINC, and HL7, and is also in the ISO 11240:2012 standard.
LOINC is a pre-coordinated laboratory coding system used in healthcare IT systems. It includes lab tests, clinical measures, HIPAA documents and standardized survey instruments. It also contains terms for human clinical research but its scope goes beyond research use. LOINC is used in over 170 countries and is mandated in 30.
CDASH and SDTM are each optimized for different purposes, and the philosophy behind each drives the design. SDTM represents cleaned, final CRF data organized in a predictable format that facilitates data transmission, review and reuse. CDASH collects the data in a user-friendly, EDC/CRF-friendly way that maximizes data quality and flows smoothly into SDTM.
"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).