Documentation

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

FDA Presentations

Industry Experience with FDA Data Submissions

PMDA Data Submissions

PMDA Guidance Documentations

PMDA Presentations

Industry Experience with PMDA Data Submissions

Good Data Validation Practice

Standards implementation

SDTM

ADaM

SEND

Define-XML

BIMO