Data Quality Checks for SDTM Datasets: FDA vs. PMDA

Understanding Regulatory Requirements for Submission Success

Introduction

Submitting SDTM datasets to regulatory authorities like the FDA (U.S. Food and Drug Administration) and PMDA (Japan's Pharmaceuticals and Medical Devices Agency) involves rigorous data quality checks. While both agencies adhere to CDISC standards, their submission guidelines and expectations differ in certain aspects. This blog explores the key differences in data quality checks for FDA and PMDA submissions.

Similarities in Data Quality Checks

Both FDA and PMDA share several common expectations for SDTM datasets:

• Adherence to CDISC Standards: Both agencies require compliance with the SDTM Implementation Guide (SDTM-IG).
• Controlled Terminology (CT): Variables such as AEDECOD and LBTESTCD must align with CDISC CT.
• Traceability: Ensures that derived datasets and analysis results can be traced back to the raw data.
• Define.xml Validation: Both agencies expect a complete and validated Define.xml file for metadata documentation.

Differences in Data Quality Checks

The FDA and PMDA have distinct preferences and requirements that need careful attention.

Aspect	FDA	PMDA
Validation Tools	Primarily uses Pinnacle 21 Community or Enterprise for validation. Emphasis on "Reject" and "Error" findings.	Relies on Pinnacle 21, but PMDA-specific validation rules are stricter. Additional checks on Japanese language and character encoding (e.g., UTF-8).
Validation Rules	Focuses on U.S.-specific regulatory rules. Requires adherence to SDTM-IG versions commonly used in the U.S.	Requires alignment with Japanese-specific validation rules. More emphasis on Trial Summary (TS) and demographic consistency.
Trial Summary (TS) Domain	FDA expects a complete TS domain but is less stringent on content beyond mandatory fields.	PMDA places greater importance on the TS domain, especially for regulatory codes specific to Japan.
Japanese Subjects	Less emphasis on Japanese-specific requirements.	Requires additional checks for Japanese subjects, such as proper handling of kanji characters.

Practical Tips for Submission Readiness

• FDA Submissions: Focus on Pinnacle 21 validation findings marked as "Reject" and address controlled terminology issues.
• PMDA Submissions: Pay extra attention to Japanese language and encoding. Validate the TS domain rigorously to include PMDA-specific codes.
• Cross-validation: Run your datasets through both FDA and PMDA validation rulesets to ensure global compliance.

Conclusion

While FDA and PMDA share a common foundation in CDISC standards, their data quality expectations have nuanced differences. Understanding these distinctions is critical for ensuring smooth submissions. By tailoring your SDTM programming and validation processes to address these unique requirements, you can enhance your submission success rate and streamline regulatory review.

Written by Sarath Annapareddy | For more insights on SDTM programming, stay connected!