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
- Installation
- MedDRA Installation
- WHODrug Installation
- SNOMED Installation
- CLI Usage
- Engine Compatibility
- Define-XML 2.1 Support
- Understanding PMDA Engines
- Known Issues in PMDA Validation Engine 1810.3
- How is P21 Community Updated?
- How to Uninstall
- FAQ
FDA Data Submissions
FDA Guidance Documentations
- Study Data Standards Resources
- 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)
- PhUSE Bioresearch Monitoring Data Reviewers Guide (BDRG) Package v1.0 (June 22, 2022)
FDA Presentations
- FDA View: Update on Study Data Submission
- Developing SEND for CBER - Collaborative Workstream Initiative
- Impact of SEND Data on FDA Review of Nonclinical Studies
- Using CDISC-SEND Standardized Data in FDA Toxicology Review: The KickStart Service
- Study Data Topics at FDA/CDER
- The Evolution of FDA Regulatory Submissions in the PDUFA Era
Industry Experience with FDA Data Submissions
PMDA Data Submissions
PMDA Guidance Documentations
- New Drug Review with Electronic Data
- 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)
- Explanation of Electronic Study Data (Form A)
- Explanation of Electronic Study Data (Form B)
PMDA Presentations
Industry Experience with PMDA Data Submissions
- Understanding PMDA Engines
- Best Practices for the Submission of Data in Japan
- Electronic Data Submission to PMDA : Our experiences and matters of concern
- Lessons Learned for Successful e-Study Data Submission to the PMDA toward the End of Transitional Period
- Challenges of Submitting Electronic Study Data to Two Authorities: the PMDA & FDA
- Process optimization for efficient and smooth e-data submissions to both FDA and PMDA
Good Data Validation Practice
- Good Data Validation Practice
- Introducing P21 Community 3.0
- How to Automate Validation with Pinnacle 21 Command Line Interface and SAS®
- 7 Habits of Highly Effective (Validation Issue) Managers
- Diagnostics of Technical Errors in define.xml File
- Best Practice for Explaining Validation Results in the Study Data Reviewer’s Guide
- Updates on validation of ADaM data
- Strategy to Evaluate the Quality of Clinical Data from CROs
- Common Pinnacle 21 Report Issues: Shall we Document or Fix?
- Exploring Common CDISC ADaM Conformance Findings
- Common Programming Errors in CDISC data
- Best Practices for Annotated CRFs
Standards implementation
SDTM
- What's New in the SDTMIG v3.3 and the SDTM v1.7
- Considerations when Representing Multiple Subject Enrollments in SDTM
- The Most Common Issues in Submission Data
- The Need for Therapeutic Area User Guide Implementation
- Findings About: De-mystifying the When and How
- Considerations and Updates in the Use of Timing Variables in Submitting SDTM-Compliant Datasets
- Implementing CDISC Standards for Device-Drug Studies
ADaM
- Incremental Changes: ADaMIG v1.2 Update
- Timing is Everything: Defining ADaM Period, Subperiod and Phase
- Practical Guidance for ADaM Dataset Specifications and Define.xml
SEND
Define-XML
- Using Pinnacle 21 Enterprise for define.xml Creation: Tips and Tricks from a CRO Perspective.
- Do's and Don'ts of Define.xml
- How to use SUPPQUAL for specifying natural key variables in define.xml?
