We have compiled a number of frequently asked questions to answer your inquiries about Controlled Terminology.
Data about medical history and prior meds are often collected at an initial study visit. Records in an SDTM-based dataset for these events and interventions will include information about their starts and ends, either in dates or relative timing variables, and will usually also include --DTC,
Historically, CDISC standards have primarily been used for regulatory submissions of clinical trials data in support of approval to market medical products. However, recent expansion of CDISC standards through therapeutic area user guide (TAUG) development and an increase in CDISC visibility has led to the recognition of the value of data standards in other areas of medical research as well.
The SDTMIG’s description of time point variables covers two different use cases:
1. A planned set of findings scheduled relative to a reference time point, usually a dose of study treatment.
2. A planned number of repeated measurements.
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.
CDISC employs a rigorous approach to developing data standards. Each standard is informed and shaped by experts, making them not just of the highest quality, but also attuned to the practicalities of their implementation.
On occasion the mapping from CDASH to SDTM is complex. This article provides a step-by-step explanation to help follow the iteration from the CDASH example to the SDTM example.
The QNAM values that appear in various examples published in the SDTMIG and TAUGs have sometimes included the domain code, and sometimes not.
In SDTMIG v3.4 and SDTM v2.0, formats for Date/Time variables are now specified as "ISO 8601 datetime or interval." You may ask “What's that interval format and when would I use it?”
SDTM v2.0 is the first major release since the model's original publication in 2004. Among many modifications and updates, the most significant change is that variable metadata is represented in a new structure.
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”.
Therapeutic Area User Guides (TAUGs) contain many useful examples, but it can be hard to find a useful example since there are over 40 TAUGs, and many TAUGs include examples that are useful outside a particular therapeutic area. The spreadsheet classifies TAUG examples by domain, so if a user has data that would be represented in a particular domain, the spreadsheet can identify TAUGs that might have examples relevant to their data.
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.
The CDASHIG section "PE - Physical Examination" describes a best practice for collecting physical examination data. Basically, any abnormalities would be recorded as medical history or adverse events, depending on timing whether an exam was performed would be recorded by treating the exam as a procedure.