We have compiled a number of frequently asked questions to answer your inquiries about Controlled Terminology.
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 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.
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.
If the safety analysis will report adverse events, clinical events, or laboratory grading according to a standard toxicity grading scale (e.g., Common Terminology Criteria for Adverse Events, CTCAE), then analysis toxicity variables should be implemented. These toxicity variables may be copied directly from SDTM as predecessor variables or they may be imputed or assigned based on the statistical analysis plan and sponsor requirements.
When development of the SDTM and SDTMIG started, SAS was used almost universally across the pharmaceutical industry and at the US FDA.
"The SAS Version 5 (V5) transport file format is an open standard developed by SAS to support data transfers between systems, especially those running different operating systems."1 SAS V5's designation as an open standard allowed FDA to specify it as the standard required for data submission.
The CDISC volunteer team that initially developed the SDTMIG was focusing on drug submissions to FDA, so it was assumed that SDTMIG had to work with the SAS V5 transport file format. This assumption led to the creation of rules such as a maximum variable name length of 8 characters, a maximum variable label length of 40 characters, and a maximum variable value length of 200 characters.
A single person may participate in a study multiple times. A common scenario for multiple participations is when a screening failure subject later goes through the screening process again in another attempt to enroll. There are also studies where a subject may participate more than once with more than 1 body part, such as a subject who participates with the left eye, and then enrolls again with the right eye. Some studies of rare diseases allow a subject to participate in and complete a study, and then later participate again. Subjects may receive different treatments in these different participations.
If an analysis is assessing low toxicity separately from high toxicity, then bidirectional toxicity variables should be used in the ADaM dataset. Toxicity variable ATOXGR may be used in addition to the bidirectional toxicity variables to capture shifts from low to high or high to low within a parameter. The low and high toxicity grade variables may be copied directly from SDTM as predecessor variables or they may be imputed or assigned based on the statistical analysis plan and sponsor requirements (e.g., unidirectional toxicity variables).