Pinnacle 21

<a href="https://help.pinnacle21.certara.net/en/articles/10492107-what-s-in-the-2405-2-validation-engine-update">What's in the 2405.2 Validation Engine update?</a> (Jan 2025)

<a href="https://www.certara.com/blog/using-real-world-data-in-clinical-trial-submissions/" rel="nofollow noopener noreferrer" target="_blank">Using Real World Data in Clinical Trial Submissions</a> (May 2024) <a href="https://youtu.be/C0rpGjolhfA?si=AknNoNZNmIw4LRWT" rel="nofollow noopener noreferrer" target="_blank">video</a>

<a href="https://www.certara.com/blog/new-fda-validator-rules-v1-6-explained/" rel="nofollow noopener noreferrer" target="_blank">FDA’s New Validation Rules v1.6 Explained</a> (Jan 2023) <a href="https://youtu.be/4V3dUvKL6qo?si=E8A2Djhlcto83WPm" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/FDA-Validator-Rules-Version-1.6.pdf">slides</a>

<a href="https://www.certara.com/on-demand-webinar/preparing-vaccine-studies-for-regulatory-submissions/" rel="nofollow noopener noreferrer" target="_blank">Preparing Vaccine Studies for Regulatory Submissions</a> (May 2021) <a href="https://youtu.be/qjfW9J6QWYk?si=NMsmAPCPtMYWNBIY" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Preparing-Vaccine-Studies-for-Regulatory-Submissions.pdf">slides</a>

<a href="https://www.certara.com/blog/how-to-prepare-a-study-data-standardization-plan-sdsp-for-fda/" rel="nofollow noopener noreferrer" target="_blank">How to Prepare a Study Data Standardization Plan</a> (Jul 2016) <a href="https://youtu.be/Lg_XnH4TV4U?si=fF4YEX_VC_Bd_7ck" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/How-to-Prepare-a-Study-Data-Standardization-Plan.pdf">slides</a>

- <a href="https://help.pinnacle21.certara.net/en/articles/10492107-what-s-in-the-2405-2-validation-engine-update">What's in the 2405.2 Validation Engine update?</a> (Jan 2025)
- <a href="https://www.certara.com/blog/using-real-world-data-in-clinical-trial-submissions/" rel="nofollow noopener noreferrer" target="_blank">Using Real World Data in Clinical Trial Submissions</a> (May 2024) <a href="https://youtu.be/C0rpGjolhfA?si=AknNoNZNmIw4LRWT" rel="nofollow noopener noreferrer" target="_blank">video</a>
- <a href="https://www.certara.com/blog/new-fda-validator-rules-v1-6-explained/" rel="nofollow noopener noreferrer" target="_blank">FDA’s New Validation Rules v1.6 Explained</a> (Jan 2023) <a href="https://youtu.be/4V3dUvKL6qo?si=E8A2Djhlcto83WPm" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/FDA-Validator-Rules-Version-1.6.pdf">slides</a>
- <a href="https://www.certara.com/on-demand-webinar/preparing-vaccine-studies-for-regulatory-submissions/" rel="nofollow noopener noreferrer" target="_blank">Preparing Vaccine Studies for Regulatory Submissions</a> (May 2021) <a href="https://youtu.be/qjfW9J6QWYk?si=NMsmAPCPtMYWNBIY" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Preparing-Vaccine-Studies-for-Regulatory-Submissions.pdf">slides</a>
- <a href="https://www.certara.com/blog/how-to-prepare-a-study-data-standardization-plan-sdsp-for-fda/" rel="nofollow noopener noreferrer" target="_blank">How to Prepare a Study Data Standardization Plan</a> (Jul 2016) <a href="https://youtu.be/Lg_XnH4TV4U?si=fF4YEX_VC_Bd_7ck" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/How-to-Prepare-a-Study-Data-Standardization-Plan.pdf">slides</a>

<a href="https://help.pinnacle21.certara.net/en/articles/11131111-what-s-new-in-pmda-engine-2411-0">What's New in PMDA Engine 2411.0</a> (Apr 2025)

<a href="https://help.pinnacle21.certara.net/en/articles/9800757-pmda-engine-update-2211-0">PMDA's New Validation Rules 4.0 Explained</a> (Mar 2023) <a href="https://youtu.be/Kg4bbQ-iAds?si=_mpZOk2i02Gf4tdW" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/PMDA-Validation-Rules-Version-4.0.pdf">slides</a>

<a href="https://www.certara.com/blog/new-pmda-validation-rules-3-0-explained/" rel="nofollow noopener noreferrer" target="_blank">PMDA's New Validation Rules 3.0 Explained</a> (Feb 2022) <a href="https://youtu.be/obTe05jWWio?si=75qj2QOO6uggtG4W" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/PMDA-Validation-Rules-Version-3.0.pdf">slides</a>

PMDA's New Validation Rules 2.0 Explained (Dec 2019) <a href="https://youtu.be/qklwE3kh9LQ?si=C_TrhTNOGivwT3v-" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/PMDA-Validation-Rules-Version-2.0.pdf">slides</a>

PMDA Validation Rule に関する解説 (Dec 2019) <a href="https://youtu.be/Bm77Uq_3RLg?si=j-q7LuZKKaaGSE1U" rel="nofollow noopener noreferrer" target="_blank">ビデオ</a>, <a href="https://help.pinnacle21.certara.net/webinars/PMDA-Validation-Rules-Version-2.0-jp.pdf">スライドショー</a>

- <a href="https://help.pinnacle21.certara.net/en/articles/11131111-what-s-new-in-pmda-engine-2411-0">What's New in PMDA Engine 2411.0</a> (Apr 2025)
- <a href="https://help.pinnacle21.certara.net/en/articles/9800757-pmda-engine-update-2211-0">PMDA's New Validation Rules 4.0 Explained</a> (Mar 2023) <a href="https://youtu.be/Kg4bbQ-iAds?si=_mpZOk2i02Gf4tdW" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/PMDA-Validation-Rules-Version-4.0.pdf">slides</a>
- <a href="https://www.certara.com/blog/new-pmda-validation-rules-3-0-explained/" rel="nofollow noopener noreferrer" target="_blank">PMDA's New Validation Rules 3.0 Explained</a> (Feb 2022) <a href="https://youtu.be/obTe05jWWio?si=75qj2QOO6uggtG4W" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/PMDA-Validation-Rules-Version-3.0.pdf">slides</a>
- PMDA's New Validation Rules 2.0 Explained (Dec 2019) <a href="https://youtu.be/qklwE3kh9LQ?si=C_TrhTNOGivwT3v-" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/PMDA-Validation-Rules-Version-2.0.pdf">slides</a>
- PMDA Validation Rule に関する解説 (Dec 2019) <a href="https://youtu.be/Bm77Uq_3RLg?si=j-q7LuZKKaaGSE1U" rel="nofollow noopener noreferrer" target="_blank">ビデオ</a>, <a href="https://help.pinnacle21.certara.net/webinars/PMDA-Validation-Rules-Version-2.0-jp.pdf">スライドショー</a>

<a href="https://www.certara.com/blog/preparing-cdisc-submissions-for-chinas-nmpa/" rel="nofollow noopener noreferrer" target="_blank">Preparing CDISC Submissions for China’s NMPA</a> (Sep 2020) <a href="https://youtu.be/wMbaJje0qYU?si=Ef5827g6ApfOZKAP" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Preparing-CDISC-Submissions-for-Chinas-NMPA.pdf">slides</a>

<a href="https://www.certara.com/blog/preparing-cdisc-submissions-for-chinas-nmpa/" rel="nofollow noopener noreferrer" target="_blank">针对向中国NMPA递交CDISC数据做准备</a> (Sep 2020) <a href="https://youtu.be/9jDm4YqKyew?si=AFg0t3y6JHuFRqgd" rel="nofollow noopener noreferrer" target="_blank">中文视频</a>, <a href="https://help.pinnacle21.certara.net/webinars/Preparing-CDISC-Submissions-for-Chinas-NMPA-zh.pdf">中文幻灯片</a>

- <a href="https://www.certara.com/blog/preparing-cdisc-submissions-for-chinas-nmpa/" rel="nofollow noopener noreferrer" target="_blank">Preparing CDISC Submissions for China’s NMPA</a> (Sep 2020) <a href="https://youtu.be/wMbaJje0qYU?si=Ef5827g6ApfOZKAP" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Preparing-CDISC-Submissions-for-Chinas-NMPA.pdf">slides</a>
- <a href="https://www.certara.com/blog/preparing-cdisc-submissions-for-chinas-nmpa/" rel="nofollow noopener noreferrer" target="_blank">针对向中国NMPA递交CDISC数据做准备</a> (Sep 2020) <a href="https://youtu.be/9jDm4YqKyew?si=AFg0t3y6JHuFRqgd" rel="nofollow noopener noreferrer" target="_blank">中文视频</a>, <a href="https://help.pinnacle21.certara.net/webinars/Preparing-CDISC-Submissions-for-Chinas-NMPA-zh.pdf">中文幻灯片</a>

<a href="https://help.pinnacle21.certara.net/en/articles/10007254-kpis-in-clinical-trial-data-management">KPIs in Clinical Trial Data Management</a> (Oct 2024)

<a href="https://www.certara.com/blog/all-you-need-to-know-about-non-crf-data-in-clinical-trials/" rel="nofollow noopener noreferrer" target="_blank">Best Practices for Non-CRF Data Management</a> (Aug 2023) <a href="https://youtu.be/xvqGqo9j6yc?si=xBbgL5Lk4D9CKbl8" rel="nofollow noopener noreferrer" target="_blank">video</a>

<a href="https://www.certara.com/blog/exploring-common-cdisc-adam-conformance-findings/" rel="nofollow noopener noreferrer" target="_blank">Exploring Common CDISC ADaM Conformance Findings</a> (Sep 2020) <a href="https://youtu.be/uSJjjwIJWlo?si=BM4nu5P5wvRjCRb5" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Common-CDISC-ADaM-Conformance-Findings.pdf">slides</a>

<a href="https://www.certara.com/on-demand-webinar/data-validation-in-clinical-research-confusing-rules-explained/" rel="nofollow noopener noreferrer" target="_blank">Confusing Data Validation Rules Explained</a> (Apr 2020) <a href="https://youtu.be/zFaMBZwlIqU?si=CEbUYe-0dvM_fJiv" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Confusing-Data-Validation-Rules-Explained.pdf">slides</a>

- <a href="https://help.pinnacle21.certara.net/en/articles/10007254-kpis-in-clinical-trial-data-management">KPIs in Clinical Trial Data Management</a> (Oct 2024)
- <a href="https://www.certara.com/blog/all-you-need-to-know-about-non-crf-data-in-clinical-trials/" rel="nofollow noopener noreferrer" target="_blank">Best Practices for Non-CRF Data Management</a> (Aug 2023) <a href="https://youtu.be/xvqGqo9j6yc?si=xBbgL5Lk4D9CKbl8" rel="nofollow noopener noreferrer" target="_blank">video</a>
- <a href="https://www.certara.com/blog/exploring-common-cdisc-adam-conformance-findings/" rel="nofollow noopener noreferrer" target="_blank">Exploring Common CDISC ADaM Conformance Findings</a> (Sep 2020) <a href="https://youtu.be/uSJjjwIJWlo?si=BM4nu5P5wvRjCRb5" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Common-CDISC-ADaM-Conformance-Findings.pdf">slides</a>
- <a href="https://www.certara.com/on-demand-webinar/data-validation-in-clinical-research-confusing-rules-explained/" rel="nofollow noopener noreferrer" target="_blank">Confusing Data Validation Rules Explained</a> (Apr 2020) <a href="https://youtu.be/zFaMBZwlIqU?si=CEbUYe-0dvM_fJiv" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Confusing-Data-Validation-Rules-Explained.pdf">slides</a>

<a href="https://help.pinnacle21.certara.net/en/articles/11010342-the-challenges-of-mapping-source-data-to-sdtm">The Challenges of Mapping Source Data to SDTM</a> (Mar 2025)

<a href="https://help.pinnacle21.certara.net/en/articles/10858976-webinar-sdtm-beyond-the-implementation-guide">SDTM Beyond the Implementation Guide</a> (Feb 2025)

<a href="https://help.pinnacle21.certara.net/en/articles/9888875-what-is-adnca-and-why-is-it-important">What is ADNCA (and why is it important)?</a> (Sep 2024) <a href="https://help.pinnacle21.certara.net/webinars/What-is-ADNCA.pdf">slides</a>

<a href="https://www.certara.com/blog/send-dataset-quality-control-best-practices-recommendations/" rel="nofollow noopener noreferrer" target="_blank">SEND Dataset Quality Control</a> (Apr 2023) <a href="https://youtu.be/jYoXtX8wLvQ?si=iLLzWjKFweeSkT-_" rel="nofollow noopener noreferrer" target="_blank">video</a>

<a href="https://www.certara.com/blog/using-sdtm-data-to-produce-patient-narratives/" rel="nofollow noopener noreferrer" target="_blank">Using SDTM Data to Produce Patient Narratives</a> (Feb 2023) <a href="https://youtu.be/JVFZ-jb7r7Q?si=td-IRwh7eDV2q_cl" rel="nofollow noopener noreferrer" target="_blank">video</a>

<a href="https://www.certara.com/on-demand-webinar/exploring-changes-in-sdtmig-3-4-adamig-1-3/" rel="nofollow noopener noreferrer" target="_blank">Changes in SDTMIG 3.4 &amp; ADaMIG 1.3</a> (Dec 2021) <a href="https://youtu.be/VUR10YdPmks?si=gJA7Q5pKtLJurpYS" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Exploring-Changes-in-SDTMIG-3.4-ADaMIG-1.3.pdf">slides</a>

<a href="https://www.certara.com/blog/industry-metrics-for-cdisc-controlled-terminology/" rel="nofollow noopener noreferrer" target="_blank">Industry Metrics for CDISC Terminology</a> (Nov 2021) <a href="https://youtu.be/psYk0MBkKbo?si=_VB_JD2g3zfXuU1Z" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Industry-Metrics-for-CDISC-Terminology.pdf">slides</a>

<a href="https://www.certara.com/on-demand-webinar/sdtm-trial-summary-domain-puzzle-are-these-the-right-pieces/" rel="nofollow noopener noreferrer" target="_blank">SDTM Trial Summary Domain Puzzle</a> (Jul 2021) <a href="https://youtu.be/DbApSQB4dBY?si=AaRopj6MbICQYn9a" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/SDTM-Trial-Summary-Domain-Puzzle.pdf">slides</a>

<a href="https://www.certara.com/blog/controlled-terminology-best-practices/" rel="nofollow noopener noreferrer" target="_blank">Controlled Terminology Best Practices</a> (Jan 2021) <a href="https://youtu.be/NPxIuUXbZzo?si=AksVqaZoBexI-7LE" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Controlled-Terminology-Best-Practices.pdf">slides</a>

<a href="https://www.certara.com/on-demand-webinar/best-practices-for-annotated-crfs/" rel="nofollow noopener noreferrer" target="_blank">Best Practices for Annotated CRFs</a> (Jul 2020) <a href="https://youtu.be/Jnqlp9UXwcQ?si=37J54Vd29M78W601" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Best-Practices-for-Annotated-CRFs.pdf">slides</a>

<a href="https://www.certara.com/on-demand-webinar/the-supplementary-domain-in-sdtm-good-bad-and-ugly/" rel="nofollow noopener noreferrer" target="_blank">SUPPQUAL Datasets: Good Bad and Ugly</a> (Jul 2020) <a href="https://youtu.be/3ApU6VOI9xM?si=C2s4SLynfATQ5wDo" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/SUPPQUAL-Datasets.pdf">slides</a>

<a href="https://www.certara.com/blog/the-dos-and-donts-of-define-xml/" rel="nofollow noopener noreferrer" target="_blank">Do’s and Don’ts of Define.xml</a> (May 2018) <a href="https://youtu.be/amYsploCXQ0?si=p43xZx0aPyKQBla4" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Dos-and-Donts-of-Define-XML.pdf">slides</a>

- <a href="https://help.pinnacle21.certara.net/en/articles/11010342-the-challenges-of-mapping-source-data-to-sdtm">The Challenges of Mapping Source Data to SDTM</a> (Mar 2025)
- <a href="https://help.pinnacle21.certara.net/en/articles/10858976-webinar-sdtm-beyond-the-implementation-guide">SDTM Beyond the Implementation Guide</a> (Feb 2025)
- <a href="https://help.pinnacle21.certara.net/en/articles/9888875-what-is-adnca-and-why-is-it-important">What is ADNCA (and why is it important)?</a> (Sep 2024) <a href="https://help.pinnacle21.certara.net/webinars/What-is-ADNCA.pdf">slides</a>
- <a href="https://www.certara.com/blog/send-dataset-quality-control-best-practices-recommendations/" rel="nofollow noopener noreferrer" target="_blank">SEND Dataset Quality Control</a> (Apr 2023) <a href="https://youtu.be/jYoXtX8wLvQ?si=iLLzWjKFweeSkT-_" rel="nofollow noopener noreferrer" target="_blank">video</a>
- <a href="https://www.certara.com/blog/using-sdtm-data-to-produce-patient-narratives/" rel="nofollow noopener noreferrer" target="_blank">Using SDTM Data to Produce Patient Narratives</a> (Feb 2023) <a href="https://youtu.be/JVFZ-jb7r7Q?si=td-IRwh7eDV2q_cl" rel="nofollow noopener noreferrer" target="_blank">video</a>
- <a href="https://www.certara.com/on-demand-webinar/exploring-changes-in-sdtmig-3-4-adamig-1-3/" rel="nofollow noopener noreferrer" target="_blank">Changes in SDTMIG 3.4 &amp; ADaMIG 1.3</a> (Dec 2021) <a href="https://youtu.be/VUR10YdPmks?si=gJA7Q5pKtLJurpYS" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Exploring-Changes-in-SDTMIG-3.4-ADaMIG-1.3.pdf">slides</a>
- <a href="https://www.certara.com/blog/industry-metrics-for-cdisc-controlled-terminology/" rel="nofollow noopener noreferrer" target="_blank">Industry Metrics for CDISC Terminology</a> (Nov 2021) <a href="https://youtu.be/psYk0MBkKbo?si=_VB_JD2g3zfXuU1Z" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Industry-Metrics-for-CDISC-Terminology.pdf">slides</a>
- <a href="https://www.certara.com/on-demand-webinar/sdtm-trial-summary-domain-puzzle-are-these-the-right-pieces/" rel="nofollow noopener noreferrer" target="_blank">SDTM Trial Summary Domain Puzzle</a> (Jul 2021) <a href="https://youtu.be/DbApSQB4dBY?si=AaRopj6MbICQYn9a" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/SDTM-Trial-Summary-Domain-Puzzle.pdf">slides</a>
- <a href="https://www.certara.com/blog/controlled-terminology-best-practices/" rel="nofollow noopener noreferrer" target="_blank">Controlled Terminology Best Practices</a> (Jan 2021) <a href="https://youtu.be/NPxIuUXbZzo?si=AksVqaZoBexI-7LE" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Controlled-Terminology-Best-Practices.pdf">slides</a>
- <a href="https://www.certara.com/on-demand-webinar/best-practices-for-annotated-crfs/" rel="nofollow noopener noreferrer" target="_blank">Best Practices for Annotated CRFs</a> (Jul 2020) <a href="https://youtu.be/Jnqlp9UXwcQ?si=37J54Vd29M78W601" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Best-Practices-for-Annotated-CRFs.pdf">slides</a>
- <a href="https://www.certara.com/on-demand-webinar/the-supplementary-domain-in-sdtm-good-bad-and-ugly/" rel="nofollow noopener noreferrer" target="_blank">SUPPQUAL Datasets: Good Bad and Ugly</a> (Jul 2020) <a href="https://youtu.be/3ApU6VOI9xM?si=C2s4SLynfATQ5wDo" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/SUPPQUAL-Datasets.pdf">slides</a>
- <a href="https://www.certara.com/blog/the-dos-and-donts-of-define-xml/" rel="nofollow noopener noreferrer" target="_blank">Do’s and Don’ts of Define.xml</a> (May 2018) <a href="https://youtu.be/amYsploCXQ0?si=p43xZx0aPyKQBla4" rel="nofollow noopener noreferrer" target="_blank">video</a>, <a href="https://help.pinnacle21.certara.net/webinars/Dos-and-Donts-of-Define-XML.pdf">slides</a>

Pinnacle 21 Webinars

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