FDA
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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 researchInvestigator responsibilities under 21 CFR 312: what changes
FDA plans a December 2026 proposal to rewrite investigator responsibilities in 21 CFR 312 subpart D. Today's duties, the record for each, and what FDA has said.
Clinical researchClinical trial participant payments: rules for sites
Clinical trial participant payments under FDA guidance, the OIG's 2026 anti-kickback request for information and the $2,000 Form 1099-MISC line for 2026.
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 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 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 researchFDA 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.