Clinical research sites
ProtocolProtocol amendment implementation at a research site
Protocol amendment implementation leaves sites on two versions for 215 days on average. The site's cutover list: IRB, training, re-consent, documents.
FDAFDA 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.
GCPICH 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.
FDAFDA 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.
FDAFDA AI principles: what a research site should do in 2026
FDA and EMA published ten principles of good AI practice on January 14, 2026, then a real-time trials pilot in April. What each asks of a research site.
RegulatoryRegulatory 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.
RecruitmentClinical trial recruitment: the first hour after a referral
Clinical trial recruitment is lost in the first hour after a referral, not in the ad budget. What the response-time research shows and how a site fixes it.
RetentionPatient retention in clinical trials: the missed visit
Phase 3 dropout is often above 30%, and most of it starts with a missed visit. What the reminder research shows and how a site catches the miss in time.