If you're trying to figure out how to represent imaging data in SDTM, it may be helpful to think about the similarities between an image and a specimen.
A sample taken from a subject for testing at a lab is a surrogate for the subject. Results of tests on the specimen tell us something about the subject at the time the specimen was taken.
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.