The following is a collection of documents, publications, and articles related to Pinnacle 21 Community, data validation and quality assessment, CDISC standards, and regulatory agencies.
Pinnacle 21 Community Documentation
FDA Data Submissions
FDA Guidance Documentations
Technical Rejection Criteria for Study Data - Incorporated into Study Data Technical Conformance Guide
Study Data Technical Conformance Guide v5.4 (June 2023)
FDA Data Standards Catalog v9.0 (January 25, 2023)
Business Rules v1.5 (May 2019)
Validator Rules v1.6 (December 2022)
PhUSE Clinical Study Data Reviewer's Guide v1.3, 2-Nov-2018
PhUSE Analysis Data Reviewer's Guide v1.2, 18-Jul-2019
Bioresearch Monitoring Technical Conformance Guide v3.0 (August 2022)
FDA Presentations
Industry Experience with FDA Data Submissions
PMDA Data Submissions
PMDA Guidance Documentations
Data Standards Catalog (2023-02-28)
FAQs on Electronic Study Data Submission (English version, April 3, 2023)
Study Data Validation Rules Version 4.0 (2023-02-28)
FAQs on Electronic Study Data Submission (English version, June 27, 2022)
Technical Conformance Guide (English version, April 1, 2022)
Study Data Validation Rules Version 1.0 (2015-11-18)
Study Data Validation Rules Version 2.0 (2019-09-27)
Study Data Validation Rules Version 3.0 (2021-12-15)
PMDA Presentations
Industry Experience with PMDA Data Submissions
Good Data Validation Practice
Standards implementation
SDTM
ADaM
SEND
Define-XML
BIMO
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