GCP
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Clinical researchInvestigational product accountability: what FDA checks
Investigational product accountability after FDA's July 2026 warning letter: what 312.62(a) requires, what FDA cites, and a four-way check for sites.
Clinical researchProtocol 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.
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.