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.
SDTM describes several types of datasets. This diagram illustrates hierarchical view of these types of datasets. Findings may be findings about a study subject or about an associated person. A finding record can be linked to supplemental qualifiers, to comments, or to other records via relationships represented in RELREC.
A query about adverse events is, at heart, an observation. Data on the adverse event may also include location and pattern. This concept map includes those details, as well as terminology that would be used in SDTM.
A substance administration consists of a substance and the activity of administering the substance. Some data items describe the substance, others the administration.
This is an example for the familiar test Temperature.
If data is collected in a log form, and if you know the range of dates or visits for collection of log data then The date or visit at which the log is initiated can be used to populate STTPT and CDASH PRIOR or ONGO can be used to populate STRTPT, The date or visit at which the log is finalized can be used to populate ENTPT and CDASH PRIOR or ONGO can be used to populate ENRTPT. STRF and ENRF are not needed and should not be used.
In ordinary conversation, depending on what “that” is, the question, “When did that happen?” could be answered in many ways. The fact that there are so many ways to say when something happened helps to explain why there are so many timing variables in SDTM.
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.