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CDISC standards in clinical trials are the cornerstone of any successful submission to regulatory agencies. While they are “standards,” the structure and the nuances of applying them are continually evolving and changing, making it important to keep up to date in order to provide quality submissions. Here at PROMETRIKA, a full-service CRO, our statistical programmers and biostatisticians engage in continuing education activities by attending webinars, conferences, and training sessions specifically related to CDISC standards in clinical trials.
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January marks the time to develop goals for the upcoming year, and for 2023, I wanted to create a goal outside of project work and pursue individual career development. I became aware of the Certified Clinical Data Manager (CCDM®) program/exam.
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Data Management (DM) and Clinical Operational teams must work hand in hand to properly execute the capture, management, and monitoring of clinical data throughout the entire life cycle of a study; however, the use of different systems, processes, and datasets makes close and effective collaboration a challenge.
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In a CRO environment, managing Data Management programming requests presents significant challenges, including prioritization, resource planning, and timely delivery of results. There are a set of recurring tasks, coming from multiple sponsors, with varying frequencies and updates needed. Programmers need a way to keep these tasks organized and to optimize the work flow.
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Recently, while performing CDISC SDTM mapping for one of our clients, a unique situation arose that involved the DA (Drug Accountability) domain. This domain tabulates the amount of treatment units dispensed to a subject and the amount returned to gauge dosing compliance for each treated subject and is often collected in a log format. On the surface, it seems like a fairly straight forward domain, but for this particular example, there were a number of factors that contributed to creating a complex scenario.