factually
Index/Topics/Regulatory Submissions

Regulatory Submissions

The process and importance of regulatory submissions in clinical trials, including the synthesis of trial conduct, statistical analyses, and results.

Fact-Checks

1 result
Feb 6, 2026

How do clinical study reports published by regulators differ from raw individual participant‑level datasets, and why does that matter for independent reanalysis?

and regulator summaries are curated, document-level narratives and aggregated analyses of trials, while individual participant data (IPD) are the raw, participant‑level records that underlie those sum...