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According to the Study Data Technical Conformance Guide (October 2024), sponsors should prepare a document called the study data standardization plan (SDSP) for each of their development programs to describe the submission of standardized non-clinical and clinical study data to the FDA.

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. 

New Drug Applications – When is it ok to not submit data to FDA? Generally speaking, the FDA wants to see all data collected during drug development – all clinical trials, across all indications, using any formulation of your drug, in any region of the world.

Regulation (EC) No 1901/2006 (the “Pediatric Regulation”) introduced the obligation for Sponsors to apply for a pediatric investigation plan (PIP) early in the drug development process and conduct their pediatric clinical trials accordingly to a PIP agreed with the EMA. Compliance with the Pediatric Regulation is mandatory for any Sponsor seeking marketing authorization for a new medicinal product in the EU.

The accelerated approval pathway has been instrumental in bringing groundbreaking therapies to patients facing serious or life-threatening conditions.

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.

Distinguishing between a medical device and a drug may be challenging to define for some products. We turn our attention to a crucial tool that Sponsors may use to have the FDA classify your product: the Request for Designation (RFD). In this blog, we’ll describe what an RFD entails and its significance in the regulatory realm, providing a comprehensive overview of the process.