FDA Reviewers

 

Specifications/Requirements

 

SDTMs/ADaMs

 

Pinnacle 21 Compliance

 Reviewer Guides

 

Define.xml

 Most Current CDISC Standards,

SDTM IG Version #

ADaM IG Version #

 Control Terminology, Version #

 xpts,

Trial Domains

 % compliance

 # Errors

 Explain all P21 errors, warnings and Notes

 Links

 Control Terms

 Value-Level Metadata


FDA Requires CDISC submissions

Electronic Regulatory Submission and Review

Providing Regulatory Submissions in Electronic Format -- Standardized Study Data

Electronic Submissions - The Requirement for Standardized Study Data

Study Data Standards Resources

FDA Resources for Data Standards

Study Data Standards in eCTD: What You Need to Know About the New Technical Rejection Criteria 

Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways 

CDISC WILL BE REQUIRED BY KIT HOWARD

CDISC Electronic Submissions, Kevin Lee [Presentation]

CDISC TA User Guides

Real World Data

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PhUSE Guidelines

SDTM / ADaM IG FAQs  Working Groups

Data Standards for Non-interventional Studies

Industry Experiences Submitting Standardized Study Data to Regulatory Authorities

State of Statistical Computing Environment Guide

FDA and PMDA Study Data Submission Distinctions


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Common FDA Review Questions to Sponsor

Common SDTM Issues

Common ADaM Questions to Sponsor

Common ADaM Issues

Differences with PMDA Questions and Issues

SDTM and ADaM Reviewer Guide Papers

FDA Submission PapersSDTM and ADaM Reviewer Guides

Submission CheckLists

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Common FDA Review Questions to Sponsor

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Common SDTM Issues

Raw to SDTM Mapping Errors - Ex. Race

Control Terminology Codelist Issues - Incorrect mapping

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Common ADaM Questions to Sponsor  (Statistical Analysis)

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Common ADaM Issues

 Rejections

 Errors 

 Warnings

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Differences with PMDA Questions and Issues

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SDTM and ADaM Reviewer Guide Papers

1. ADaM Reviewer’s Guide – Interpretation and Implementation, Steve Griffiths [Presentation]

2. Proposal for Streamlining the SDRG and ADRG Authoring Process, Stanley Wei [SDTM and ADaM Reviewer's Guide]

3. Who, What, When, Where and How: Basics of Analysis Data Reviewer’s Guide (ADRG) [Presentation]

4. ACHIEVING CLARITY THROUGH PROPER STUDY DOCUMENTATION: AN INTRODUCTION TO THE STUDY DATA REVIEWER'S GUIDE (SDRG)

5. Leveraging Study Data Reviewer’s Guide (SDRG) in Building FDA’s Confidence in Sponsor’s Submitted Datasets, Xiangchen Cui, Min Chen and Letan Lin

6. Worst CDISC Implementation Processes – How to Avoid Some Very Basic Mistakes in SDTM, ADaM, Define.xml and Reviewer’s Guide Production, Hannes Raeder, Michael Reich

7. A Practical Guide to the Issues Summary in the Data Conformance Summary of Reviewer’s Guides, Gary Moore 

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FDA Submission Papers

l1. Industry Experiences Submitting Standardized Study Data to Regulatory Authorities, Vincent Guo, Janet Low, Kiran Kundarapu, Cathy Michalsky, Todd Case [Presentation]

2. Information Requests During an FDA Review, Hong Qi, Lei Xu, Mary Varughese

3. Challenges of Submitting Electronic Study Data to Two Authorities: PMDA and FDA, Torsten Petsching, Nick De Donder

4. EMA, Health Canada, FDA and PMDA: Four agencies tackle Data Sharing. Synergies and Differences, Jean-Marc Ferran, Liz Roberts

5. Submission of software programs to regulatory agencies, Maria Dalton

6. Electronic Submissions - The Requirement for Standardized Study Data [Presentation]

7. Evidence of Clinical Effectivess and Data Requirements for an NDA [Presentation]

8. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry

9. The Y2K17 Bug! Using Metadata to Respond to PDUFA V Requirements Vincent J. Amoruccio

10. The Evolution of FDA Regulatory Submissions in the PDUFA Era

11. Getting Rid of Bloated Data in FDA Submissions

12. Ready, Set, Go: Planning and Preparing a CDISC Submission Maria Dalton

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Submission CheckLists





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