SDTMIG v4.0: Are You Ready For It?
Source category: Data Standards Implementation (CDISC, SEND, ADaM, SDTM)
Author collections: Kristin Kelly
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Kristin Kelly — Indexed Papers
Publications credited to Kristin Kelly in the available conference metadata. Browse coauthors and original source links below. This is a publication index, not a verified biographical profile; identical names may refer to different people.
28 papers · Showing 1–28
SDTMIG v4.0: Are You Ready For It?
Source category: Data Standards, Governance & Implementation
Author collections: Kristin Kelly
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies
Source category: Submission Standards
Author collections: Kristin Kelly
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies
Source category: Submissions & Agencies (SA)
Author collections: Kristin Kelly
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies
Source category: Submissions & Agencies
Author collections: Kristin Kelly
Guidance Beyond the SDTM Implementation Guide
Source category: Data Standards
Author collections: Kristin Kelly · Michael Beers
Guidance Beyond the SDTM Implementation Guide
Source category: Data Standards & Governance
Author collections: Kristin Kelly · Michael Beers
Guidance Beyond the SDTM Implementation Guide
Source category: Data Standards & Governance
Author collections: Kristin Kelly · Michael Beers
‘TUFF’ LOVE: SDTM Pain Points EXPLAINED!
Source category: Data Standards
Author collections: Kristin Kelly · Michael Beers
Explanations in the Study Data Reviewer’s Guide: How’s It Going?
Source category: Submission Standards
Author collections: Kristin Kelly
Explanations in the Study Data Reviewer’s Guide: How’s It Going?
Source category: Data Standards & Governance
Author collections: Kristin Kelly
Preparing Vaccine Studies for Regulatory Submissions
Source category: Submissions & Agencies
Author collections: Kristin Kelly
Getting it Right: Refinement of SEND Validation Rules
Source category: Submissions & Agencies
Author collections: Kristin Kelly
Getting It Right: Refinement of SEND Validation Rules
Source category: Submission Standards
Author collections: Kristin Kelly
Getting It Right: Refinement of SEND Validation Rules
Source category: Submissions & Agencies
Author collections: Kristin Kelly
SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?
Source category: Data Standards and Governance
Author collections: Kristin Kelly
Considerations when Representing Multiple Subject Enrollments in SDTM
Source category: Data Standards
Author collections: Kristin Kelly
DS07 Considerations when Representing Multiple Subject Enrolments in SDTM
Source category: Data Standards and Governance
Author collections: Kristin Kelly
DS14 Considerations When Representing Multiple Subject Enrollments in SDTM
Source category: Data Standards and Governance
Author collections: Kristin Kelly
Best Practice for Explaining Validation Results in the Study Data Reviewer’s Guide
Source category: Submission Standards
Author collections: Kristin Kelly
Best Practice for Explaining Validation Results in the Study Data Reviewer’s Guide
Source category: Data Standards & Governance
Author collections: Kristin Kelly · Michael Beers
Best Practices for Explaining Validation Results in the Study Data Reviewer's Guide
Source category: Data Standards and Governance
Author collections: Kristin Kelly
SDTM EX and EC: Considerations When Submitting Exposure Data
Source category: Data Standards
Author collections: Kristin Kelly · Jerry Salyers
Documenting Traceability for the FDA: Clarifying the Legacy Data Conversion Plan & Introducing the Study Data Traceability Guide
Source category: Submission Standards
Author collections: David Izard · Kristin Kelly
Considerations and Conventions within the Therapeutic Area User Guides (TAUGs)
Source category: Data Standards
Author collections: Jerry Salyers · Kristin Kelly · Fred Wood
SDTM Trial Summary Domain: Putting Together the TS Puzzle
Source category: Data Standards
Author collections: Kristin Kelly · Jerry Salyers · Fred Wood
SDTM TE, TA, and SE Domains: Demystifying the Development of SE
Source category: Data Standards
Author collections: Kristin Kelly · Fred Wood · Jerry Salyers
Considerations in the Submission of Exposure Data in SDTM-Based Datasets
Source category: Data Standards
Author collections: Fred Wood · Jerry Salyers · Richard Lewis · Kristin Kelly