Pinnacle 21

<a href="https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources" target="_blank" rel="nofollow noopener noreferrer">Study Data Standards Resources</a>

<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document" target="_blank" rel="nofollow noopener noreferrer">Technical Rejection Criteria for Study Data</a> - Incorporated into Study Data Technical Conformance Guide

<a href="https://www.fda.gov/media/153632/download" target="_blank" rel="nofollow noopener noreferrer">Study Data Technical Conformance Guide v5.4</a> (June 2023)

<a href="https://www.fda.gov/media/160564/download" target="_blank" rel="nofollow noopener noreferrer">FDA Data Standards Catalog v9.0</a> (January 25, 2023)

<a href="https://www.fda.gov/media/116935/download" target="_blank" rel="nofollow noopener noreferrer">Business Rules v1.5</a> (May 2019)

<a href="https://www.fda.gov/media/103587/download" target="_blank" rel="nofollow noopener noreferrer">Validator Rules v1.6</a> (December 2022)

<a href="https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/Clinical+SDRG.zip" target="_blank" rel="nofollow noopener noreferrer">PhUSE Clinical Study Data Reviewer's Guide v1.3</a>, 2-Nov-2018

<a href="https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/ADRG+Packages+V1.2.zip" target="_blank" rel="nofollow noopener noreferrer">PhUSE Analysis Data Reviewer's Guide v1.2</a>, 18-Jul-2019

<a href="https://www.fda.gov/media/85061/download" target="_blank" rel="nofollow noopener noreferrer">Bioresearch Monitoring Technical Conformance Guide v3.0</a> (August 2022)

<a href="https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/TP-034.zip" target="_blank" rel="nofollow noopener noreferrer">PhUSE Bioresearch Monitoring Data Reviewers Guide (BDRG) Package v1.0</a> (June 22, 2022)

- <a href="https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources" target="_blank" rel="nofollow noopener noreferrer">Study Data Standards Resources</a>
- <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document" target="_blank" rel="nofollow noopener noreferrer">Technical Rejection Criteria for Study Data</a> - Incorporated into Study Data Technical Conformance Guide
- <a href="https://www.fda.gov/media/153632/download" target="_blank" rel="nofollow noopener noreferrer">Study Data Technical Conformance Guide v5.4</a> (June 2023)
- <a href="https://www.fda.gov/media/160564/download" target="_blank" rel="nofollow noopener noreferrer">FDA Data Standards Catalog v9.0</a> (January 25, 2023)
- <a href="https://www.fda.gov/media/116935/download" target="_blank" rel="nofollow noopener noreferrer">Business Rules v1.5</a> (May 2019)
- <a href="https://www.fda.gov/media/103587/download" target="_blank" rel="nofollow noopener noreferrer">Validator Rules v1.6</a> (December 2022)
- <a href="https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/Clinical+SDRG.zip" target="_blank" rel="nofollow noopener noreferrer">PhUSE Clinical Study Data Reviewer's Guide v1.3</a>, 2-Nov-2018
- <a href="https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/ADRG+Packages+V1.2.zip" target="_blank" rel="nofollow noopener noreferrer">PhUSE Analysis Data Reviewer's Guide v1.2</a>, 18-Jul-2019
- <a href="https://www.fda.gov/media/85061/download" target="_blank" rel="nofollow noopener noreferrer">Bioresearch Monitoring Technical Conformance Guide v3.0</a> (August 2022)
- <a href="https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/TP-034.zip" target="_blank" rel="nofollow noopener noreferrer">PhUSE Bioresearch Monitoring Data Reviewers Guide (BDRG) Package v1.0</a> (June 22, 2022)

<a href="https://www.lexjansen.com/phuse-us/2019/sa/SA15.pdf" target="_blank" rel="nofollow noopener noreferrer">FDA View: Update on Study Data Submission</a>

<a href="https://www.lexjansen.com/phuse-us/2019/sa/SA06.pdf" target="_blank" rel="nofollow noopener noreferrer">Developing SEND for CBER - Collaborative Workstream Initiative</a>

<a href="https://www.lexjansen.com/phuse-us/2019/sa/SA09.pdf" target="_blank" rel="nofollow noopener noreferrer">Impact of SEND Data on FDA Review of Nonclinical Studies</a>

<a href="https://www.lexjansen.com/phuse-us/2019/sa/SA10.pdf" target="_blank" rel="nofollow noopener noreferrer">Using CDISC-SEND Standardized Data in FDA Toxicology Review: The KickStart Service</a>

<a href="https://www.lexjansen.com/pharmasug/2019/FDA/PharmaSUG-2019-FDA-G001.pdf" target="_blank" rel="nofollow noopener noreferrer">Study Data Topics at FDA/CDER</a>

<a href="https://www.lexjansen.com/pharmasug/2019/FDA/PharmaSUG-2019-FDA-K001.pdf" target="_blank" rel="nofollow noopener noreferrer">The Evolution of FDA Regulatory Submissions in the PDUFA Era</a>

- <a href="https://www.lexjansen.com/phuse-us/2019/sa/SA15.pdf" target="_blank" rel="nofollow noopener noreferrer">FDA View: Update on Study Data Submission</a>
- <a href="https://www.lexjansen.com/phuse-us/2019/sa/SA06.pdf" target="_blank" rel="nofollow noopener noreferrer">Developing SEND for CBER - Collaborative Workstream Initiative</a>
- <a href="https://www.lexjansen.com/phuse-us/2019/sa/SA09.pdf" target="_blank" rel="nofollow noopener noreferrer">Impact of SEND Data on FDA Review of Nonclinical Studies</a>
- <a href="https://www.lexjansen.com/phuse-us/2019/sa/SA10.pdf" target="_blank" rel="nofollow noopener noreferrer">Using CDISC-SEND Standardized Data in FDA Toxicology Review: The KickStart Service</a>
- <a href="https://www.lexjansen.com/pharmasug/2019/FDA/PharmaSUG-2019-FDA-G001.pdf" target="_blank" rel="nofollow noopener noreferrer">Study Data Topics at FDA/CDER</a>
- <a href="https://www.lexjansen.com/pharmasug/2019/FDA/PharmaSUG-2019-FDA-K001.pdf" target="_blank" rel="nofollow noopener noreferrer">The Evolution of FDA Regulatory Submissions in the PDUFA Era</a>

Industry Experience with FDA Data Submissions

<a href="https://www.lexjansen.com/pharmasug/2019/SS/PharmaSUG-2019-SS-291.pdf" target="_blank" rel="nofollow noopener noreferrer">Information Requests During An FDA Review</a>

- <a href="https://www.lexjansen.com/pharmasug/2019/SS/PharmaSUG-2019-SS-291.pdf" target="_blank" rel="nofollow noopener noreferrer">Information Requests During An FDA Review</a>

FDA Data Submissions

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FDA Data Submissions

FDA Guidance Documentations

FDA Presentations

Industry Experience with FDA Data Submissions