Site operations
Every post about site operations, newest first.
Clinical researchEHR to EDC integration: what a research site checks first
Mount Sinai now fills about 70% of eCRF data from Epic automatically. What EHR to EDC changes for a site, what FDA expects, and what to ask first.
Clinical researchClinical trial site burden: measure it before a sponsor asks
Bain's 2026 survey says twice as many sites expect capacity to worsen. Five numbers a research site can count on its own studies to show where the hours go.
Clinical researchSharing study results with participants: NIH's draft policy
NIH's draft policy would require plain-language results for participants in NIH-supported research. What a site records now; comments close October 26, 2026.
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 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.