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About the Blogs category
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23
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March 24, 2025
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Controlled Terminology Best Practices
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35
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March 3, 2021
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Mapping Considerations for Screen Failure, Not Assigned, and Not Treated Subjects
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69
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June 18, 2020
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SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?
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36
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September 11, 2021
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Using Real World Data in Clinical Study Submissions
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48
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June 17, 2024
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Pinnacle 21 Releases P21 Community 4.1.0
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41
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May 31, 2024
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P21 Releases New PMDA, FDA, NMPA Validation Engines
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92
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April 23, 2024
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SDTM Data Handoffs: Using Biostats Data to Produce Patient Narratives
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32
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April 25, 2023
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SEND Dataset QC: Best Practices & Recommendations
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41
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April 25, 2023
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PMDA Releases New Validator Engine 2211.0
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49
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April 7, 2023
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FDA’s New Validation Rules Explained
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62
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January 16, 2023
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Pinnacle 21 Releases P21 Community 4.0
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65
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April 25, 2022
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P21 Adds Support for CDISC Open Rules Engine (CORE)
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19
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April 25, 2022
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New PMDA Validation Rules 3.0 Explained
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58
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March 2, 2022
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Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3
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59
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January 5, 2022
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P21 Releases New PMDA Validation Engine
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43
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December 20, 2021
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Certara Acquires Pinnacle 21!
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37
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December 10, 2021
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Industry Metrics for CDISC Terminology
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48
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November 17, 2021
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Preparing Vaccine Studies for Regulatory Submissions
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27
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September 11, 2021
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CDISC ADaM Validation with P21
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61
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December 2, 2020
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Formatting Annotated Case Report Forms (aCRFs): Part 4
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49
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November 13, 2020
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Preparing CDISC Submissions for China’s NMPA [Updated]
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41
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October 30, 2020
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CDISC ADaM Submission Recommendations
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33
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October 12, 2020
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Formatting Annotated Case Report Forms (aCRFs): Part 3
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29
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October 9, 2020
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CDISC ADaM Implementation Recommendations
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84
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September 28, 2020
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Exploring Common CDISC ADaM Conformance Findings
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12
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September 16, 2020
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New Pinnacle 21 Community Validation Engine: FDA (1907.2)
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75
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September 13, 2020
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Formatting Annotated Case Report Forms (aCRFs): Part 2
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33
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September 10, 2020
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Formatting Annotated Case Report Forms (aCRFs): Part 1
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27
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August 12, 2020
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Best Practices for Annotated CRFs
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37
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August 4, 2020
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