Study Data Technical Rejection Criteria (TRC) Considerations for Multiple Data Packages in a Single Submission
Source category: Submission Standards
Author collections: Christine Teng · Janet Low
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Janet Low — Indexed Papers
Publications credited to Janet Low 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.
7 papers · Showing 1–7
Industry Experiences Submitting Standardized Study Data to Regulatory Authorities
Source category: Submissions & Agencies
Author collections: Janet Low · Vincent Guo
What You Need to Know About Submitting Data to the FDA
Source category: Data Standards and Governance
Author collections: Janet Low · Pritesh Solanki
DS04 What Does Good Look Like in the Study Data Standardization Plan (SDSP)?
Source category: Data Standards and Governance
Author collections: Pritesh Solanki · Janet Low
DS11 Striking a Balance: Adoption of Analysis Results Metadata (ARM) in Early Development Studies
Source category: Data Standards and Governance
Author collections: Janet Low · Pranab K. Mitra
Sponsor Considerations for Building a Reviewer’s Guide to Facilitate BIMO (Bioresearch Monitoring) Review
Source category: Submission Standards
Author collections: Kiran Kundarapu · Janet Low · Majdoub Haloui
Comparing and Contrasting Differences between the PHUSE SDSP and CBER Checklist
Source category: Data Standards and Governance
Author collections: Janet Low · Pritesh Solanki