Regulatory
Every post about regulatory, newest first.
Clinical researchFDA single IRB requirement: what a research site prepares
FDA's single IRB rule for multisite studies is listed for December 2026 and takes effect a year after it publishes. What a research site prepares now.
Clinical researchClinicalTrials.gov results reporting: the site's deadlines
ClinicalTrials.gov results reporting falls on the responsible party. When that is your own investigator, here are the two dates and the checks to run.
Clinical researchFDA inspection of a clinical trial site: the 2026 guide
How an FDA inspection of a clinical trial site runs in 2026, what FDA cited at sites in FY 2024, and what a research site prepares before the phone call.
Clinical researchICH E6(R3) Annex 2: what a research site changes
ICH adopted Annex 2 on June 3, 2026; the EU applies it from January 15, 2027. What it asks investigators on remote consent, home dosing and local clinicians.
Clinical researchFDA Expedited IND pilot: what it means for a research site
FDA opened its Expedited IND pilot on September 15, 2026; applications close October 30. Who qualifies, what an institution must show, what a site does.
Clinical researchRegulatory binder: the documents that expire, and when
A regulatory binder is a calendar, not a filing job. The expiry dates in it, what FDA inspectors cited in FY2024, and how a site stays ahead of both.