GCP Blog — Field notes from clinical research
Recent dispatches
Central vs. Local IRB: What a Reliance Agreement Moves, and the GCP Duties It Can Never Transfer
Teams stand up a multisite study, pick a well-known central IRB, sign a reliance agreement, and quietly assume the accountability moved with the review.
ReadVulnerable Populations in Clinical Research: A Triage-and-Safeguard Playbook (Not a List to Memorize)
This guide converts the textbook list into a decision path: classify the vulnerability, then map it to the safeguard the regulation actually requires at protocol design, consent, IRB submission, and monitoring.
ReadDrug Accountability in Clinical Trials: Closing the Custody Chain Before the Inspector Opens the Log
Most accountability guidance hands you a template and calls it done: subject ID, lot, quantity, dispenser initials.
ReadFrom Word Template to Defensible Essential Document: Making an Informed Consent Form GCP-Compliant
You searched for a consent form template, you found a Word file, and you are about to paste in your protocol title and start enrolling.
ReadClinical Research Coordinator Responsibilities: A Delegation-Mapped Guide to Staying In Scope for an FDA Inspection
A clinical research coordinator operationalizes the investigator's delegated duties; the role is not a standalone job defined by a generic task list.
ReadRemote Monitoring in Clinical Trials: An RBQM Method That Survives an Inspection, Not a COVID Stopgap
The fastest way to fail an inspection of a remote monitoring program is to describe it the way most CRO blogs still do: as something teams started doing in 2020 because they could not get on-site, and never formalized.
ReadMedical Monitor Responsibilities in Clinical Trials: The Four Safety Decisions, Their Reporting Clocks, and the Records That Prove Them
ICH E6(R3) never uses the words "medical monitor." That absence is exactly why the role gets mis-scoped on study after study, and why the top search results blur it into the CRA's site-monitoring job.
ReadFDA DSUR Guidance: The DIBD-Anchored Annual Filing That Consolidates Your IND Annual Report (Not a Template)
Most DSUR guides hand you the ICH E2F table of contents and walk you through twenty sections.
ReadProtocol Feasibility Assessment as an ICH E8 Quality-by-Design Gate: Run It on the Draft, Before Lock
The most common feasibility anti-pattern in clinical operations is mailing a questionnaire to candidate sites after the protocol is already final and calling the response rate "feasibility." That exercise answers a recruitment question for a business-development pipeline.
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