GCP Blog — Field notes from clinical research
Recent dispatches
The Trial Master File Checklist That Survives an Inspection: Completeness, Timeliness, and Quality Over a Document List
If you are standing up a TMF or QC-ing one, the question is not "do we have the documents?" It is "would this file let an inspector reconstruct the trial today, with no gaps and no late filing, without anyone explaining it to them?" That standard, not a printed list, is what this article is built around.
ReadCentral 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.
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