Description

In this QCast episode, Jullia and Tom demystify case report form annotation in clinical trials. They explain what an annotated CRF is, why it is central to traceability and compliance, and how teams use CDASH at collection and SDTM at tabulation to keep mappings clean.

Key Takeaways

• Treat the annotated CRF as the contract between collection and analysis to ensure end-to-end traceability.
• Start from CDASH templates and map cleanly to SDTM; extend standards only with clear rationale.
• Lock units and controlled terminology early to avoid reconciliation churn and mapping gaps.
• Run cross-functional reviews with data management, programming, statistics, and safety before go-live.
• Manage changes with controlled versions, dated effective changes, and clear training for sites.
• Document external data sources and transformation notes in the aCRF to unify all acquisition channels.
• Avoid free text where coded lists fit, and annotate conditional logic to prevent false “missing” patterns.

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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.