Effective data presentation for FDA Submissions is critical for regulatory submissions.
The FDA requires that data be presented clearly, accurately, and in a standardized format to facilitate review.
Electronic Common Technical Document (eCTD)
Structure: Five modules covering administrative information, summaries, quality, non-clinical, and clinical data.
Standardization: Ensures consistency across submissions.
Data Standards for FDA Submissions
CDISC (Clinical Data Interchange Standards Consortium)
SDTM (Study Data Tabulation Model): Organizes data collected during clinical trials.
ADaM (Analysis Data Model): Structures data for analysis.
FDA's Data Standards Catalog: Specifies acceptable formats.
Key Principles
Clarity
Tables and Figures: Should be well-labeled and easy to interpret.
Narrative Summaries: Provide context and explanations.
Accuracy
Data Verification: Ensure data matches source documents.
Consistency: Align data across different sections.
Completeness
All Relevant Data: Include both positive and negative findings.
Transparency: Disclose methodologies and limitations.
Compliance
Regulatory Requirements: Adhere to FDA guidelines on data presentation.
Good Clinical Data Management Practices
Common Pitfalls to Avoid
Incomplete Datasets: Missing critical information.
Inconsistent Data: Discrepancies between datasets.
Poor Formatting: Non-standardized presentations hinder review.