Most of those who work with Clinical Data Interchange Standards Consortium (CDISC) datasets have probably heard of the term “traceability.” But why is it important and how can it best be implemented?
Real-world data (RWD) has become a buzzword phrase in recent articles in clinical trial research. But there is often a difference between the idealistic and future use of RWD and how it can and is practically being used to advance drug development. What is RWD? How is RWD being applied now? What are the potential uses for it in the future?
In complex or longer duration clinical studies, it is common to submit the data up to a predetermined date, often known as the Data Cutoff Date. We will discuss how data cutoff is implemented in SDTM database, since SDTMs are the source data for submission.
Do I need to up-version to the most recent versions of the standard from the current Catalog when preparing to submit clinical study data? How can I figure this out? Check out the latest blog from Rho to find out.
In clinical trials, the accuracy and integrity of data are paramount. While the goal is to handle data systematically and programmatically, there are occasions when hardcoding becomes necessary. Note the following considerations for when to hardcode and the importance of documenting these decisions.
“Do the studies in our program meet the FDA standards for demonstrating effectiveness?” is a question that sponsors frequently ask here at Rho. Demonstrating the efficacy of your product is an integral component of an application, but the flexibility surrounding what qualifies as substantial evidence from the FDA’s perspective can often leave you scratching your head.
The US Food and Drug Administration (FDA) recently finalized a guidance document outlining the agency’s thinking on Submitting Patient-Reported Outcome Data Cancer clinical Trials. The guidance illustrates the importance of choosing a PRO vendor that is capable of capturing the recommended content and framework as source data if possible. This will reduce the need for time-consuming and potentially error prone data manipulation in SDTM and ADaM.
The US Food and Drug Administration (FDA) recently finalized a guidance document outlining the agency’s thinking on Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory. The guidance lays out technical specifications to consider when submitting clinical outcome assessment (COA) information that uses Item Response Theory (IRT) in a marketing application.
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