In all versions of the SDTMIG through v3.2, the "Conformance" section includes the following as a criterion for conformance:
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.
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.
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.
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.
CDISC has published the first of a new kind of QRS supplement to the SDTMIG, a supplement for an oncology response criterion, Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
This article provides information on the ISO international standard for country codes is ISO-3166, which provides several representations of names for countries (ISO-3166-1) and their subdivisions (ISO-3166-2).
For human clinical trials, there is a growing movement to replace the term "study subject" with a terminology that is more respectful and recognizes the agency of those who consent to be treated and have their data collected. The term "participant”, rather than "study subject", is now used in ICH E6 R3 guidelines. The TransCelerate Biopharma Common Protocol Template states that "participant" may be used in patient-facing documents.
The CDISC Analysis Data Model Implementation Guide (ADaMIG) provides several timing variables for modeling clinical trial designs in analysis datasets. APHASE, APERIOD, and ASPER can be used in conjunction with related treatment variables to meet a variety of analysis requirements, from single-period parallel studies to much more complicated situations involving multiple treatment periods and even different studies. The goal of this article is to provide guidelines for identifying when to use the different timing variables that are available. Additional examples can be found in the References and Resources listed at the end of the article.
This article aims to clarify and establish a shared understanding of the recommended CDISC approach for identifying CDISC Biomedical Concepts (BCs) within a defined group of interest, with particular emphasis on Questionnaires, Ratings, and Scales (QRS) instruments.
The ADaMIG provides multiple ways to categorize and flag values to be analyzed. These ways may seem overlapping, and the most appropriate set of variables for a particular analysis may not be obvious to the user. This article is intended to provide some clarity on how to use appropriate variables and how to select the appropriate analysis variables.
The SDTM Implementation Guide for Associated Persons (SDTMIG-AP) v1.0 provides guidance on how to include data collected about persons who are not the study subjects in SDTM. However, the ADaM Implementation Guide has not provided guidance regarding how to include data from SDTM AP-- domains in ADaM datasets if needed for analysis.