Episode Details

In this QCast episode, Jullia and Tom discuss CDASH standards and conformance in clinical data management, with a focus on where CDASH sits in the clinical data flow and why it matters before data reaches SDTM. The episode looks at CRF and eCRF design, naming conventions, metadata, controlled terminology, ePRO and eSource data, and the practical problems that can appear when collection standards are applied too late.

Key Takeaways

• CDASH applies at the point of data collection. It helps teams collect clinical trial data consistently before it is mapped into SDTM for review and submission.
• Conformance depends on more than including the right fields. Naming conventions, metadata and traceability all affect whether data can move cleanly from capture through to SDTM.
• Early alignment reduces avoidable rework. Bringing data management and programming into CRF design can help prevent repeated queries, unclear site responses and manual review issues later.

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📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
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About Quanticate

Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in:

• Clinical Data Capture & Management
• Biostatistics & Statistical Consultancy
• Statistical Programming & PK/PD Analysis
• Medical Writing & Pharmacovigilance
• Regulatory & Submission Support
• AI & Automation
• Post-Marketing Safety & Real-World Data

Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.