From Protocol to cSDRG: how to write cSDRG study design section

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As clinical research professionals, we often grapple with a unique challenge: transforming our forward-looking protocol documents into retrospective study documentation. One particular area where this becomes crucial is in the Clinical Study Data Reviewer's Guide (cSDRG), especially when documenting the Study Design section. Today, we'll explore why simply copying and pasting from your protocol isn't the best approach, and how to effectively translate your study design documentation into its proper historical context.

Why Time Matters in Clinical Documentation

The protocol and cSDRG serve fundamentally different purposes in the clinical research narrative. Your protocol is your roadmap - it outlines what you plan to do. The cSDRG, on the other hand, tells the story of what actually happened. This distinction is crucial for regulatory reviewers who need to understand how your study unfolded in reality.

Pro Tip: Think of your protocol as a travel itinerary and your cSDRG as a travel journal. While your itinerary shows where you planned to go, your journal documents where you actually went and what really happened along the way.

The Art of Translation: From Future to Past

Converting your study design documentation isn't just about changing verb tenses - it's about capturing the reality of your study execution. Here's how to approach this transformation effectively:

Example Transformations

Protocol (Future Tense) cSDRG (Past Tense)
"This will be a randomized, double-blind study that will enroll 100 subjects..." "This was a randomized, double-blind study that enrolled 98 subjects..."
"Subjects will receive treatment for 12 weeks..." "Subjects received treatment for 12 weeks, with a mean treatment duration of 11.2 weeks..."
"Blood samples will be collected at baseline and weeks 4, 8, and 12." "Blood samples were collected at baseline and weeks 4, 8, and 12, with additional unscheduled sampling as needed."

Best Practices for Study Design Documentation

When preparing your cSDRG Study Design section, consider these key principles:

  1. Use Actual Numbers: Replace planned enrollment figures with actual participant counts.
  2. Document Deviations: Include any significant departures from the planned design that occurred during study execution.
  3. Maintain Consistency: Ensure all descriptions align with the past-tense reporting style used throughout the cSDRG.
  4. Add Context: Include relevant details about how procedures were actually implemented.

The Impact on SDTM Integration

This careful translation of study design documentation becomes particularly important when working with Study Data Tabulation Model (SDTM) datasets. Your cSDRG serves as a bridge between your protocol's intentions and your SDTM data's reality, helping reviewers understand any discrepancies or special circumstances that emerged during the study.

Remember: Your cSDRG should tell the story of your study as it actually happened, providing context for your SDTM datasets and helping reviewers understand your data in its proper context.

Conclusion

Creating an effective cSDRG Study Design section requires more than simple copy-and-paste operations from your protocol. By thoughtfully translating your study design documentation into past tense and incorporating actual study outcomes, you create a more valuable resource for regulatory reviewers and maintain the integrity of your clinical study documentation.

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