Formatting Annotated Case Report Forms (aCRFs): Multiple copies and/or multiple versions of forms Blog Formatting Annotated Case Report Forms (aCRFs): Multiple copies and/or multiple versions of forms Streamline aCRF formatting by mastering versions, repeated pages, and compliance essentials. Read the third blog…Certara2020年10月9日
New Pinnacle 21 Community Validation Engine: FDA (1907.2) Announcement New Pinnacle 21 Community Validation Engine: FDA (1907.2) In August 2020, we released our new Pinnacle 21 validation engine “FDA (1907.2)” for preparing…Certara2020年9月13日
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Exploring Common CDISC ADaM Dataset Conformance Findings On-Demand Webinar Exploring Common CDISC ADaM Dataset Conformance Findings What you need to know when validating your CDISC ADAM datasets During the regulatory review…Certara2020年9月3日
Formatting Annotated Case Report Forms (aCRFs): Part 1 Blog Formatting Annotated Case Report Forms (aCRFs): Part 1 Discover essential tips for formatting aCRFs with clarity and regulatory compliance in mind. Read the…Certara2020年8月12日
Best Practices for Annotated CRFs On-Demand Webinar Best Practices for Annotated CRFs In this webinar, Amy Garrett reviews published guidance from regulatory agencies and provides best practices…Certara2020年7月30日
Understanding the Duplicate Records Validation Rules Blog Understanding the Duplicate Records Validation Rules In this blog, we clarify the meaning & purpose of the duplicate records validation rules,…Certara2020年7月7日
The supplementary domain in SDTM: good, bad and ugly On-Demand Webinar The supplementary domain in SDTM: good, bad and ugly All you need to know about the supplementary domain in SDTM The supplementary domain in…Certara2020年7月2日
Mapping Considerations for Screen Failure, Not Assigned, and Not Treated Subjects Blog Mapping Considerations for Screen Failure, Not Assigned, and Not Treated Subjects In this blog, we clarify the best practices when mapping data for screen failure, not assigned,…Certara2020年6月18日
How to Implement the EPOCH Variable Blog How to Implement the EPOCH Variable Implement the EPOCH variable in clinical data efficiently. Get expert tips for accurate derivation, error…Certara2020年6月5日