GCP Blog — Field notes from clinical research
September 2026 Edition 113 pieces in print
Recent dispatches
GCP
The IRB Approval Lifecycle: Keeping Approval Continuously Valid Through Continuing Review, Amendments, and the Lapse You Must Avoid
This guide is written for the people who actually keep a study's IRB relationship valid day to day: clinical research coordinators, site and sponsor regulatory and QA staff, and clinical-ops leads juggling continuing-review dates and amendments across multiple sites.
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IRB Continuing Review for Greater-Than-Minimal-Risk Studies: The Annual Floor, the Expiration Cliff, and What Still Needs Renewing
This is a workflow article, not a glossary.
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IRB Waiver of Consent: Three Decisions, Five Criteria, and What the 2024 FDA Rule Changed
When a coordinator says "we got a consent waiver," they could mean any of three legally distinct things.
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Informed Consent Form Template: Build an Inspection-Ready ICF from the Required-Elements Checklist (ICH E6(R3) / 21 CFR 50)
If you searched for an "informed consent form template," you were probably hoping for a blank .doc you could drop your protocol title into and print.
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Data Safety Monitoring Board (DSMB): When You Need One, and How to Charter It
Most teams ask "should we have a DSMB?" far too late, usually when a reviewer flags its absence.
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Pharmacovigilance in Clinical Trials: The Classify-Then-Clock Workflow for AE, SAE, and SUSAR Reporting
Most pharmacovigilance (PV) explainers tell you that PV is the science of monitoring drug safety and that it is important.
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SAE Reconciliation: A Field-Level Discrepancy-Resolution Workflow That Closes Before Lock and Never Lags the SUSAR Clock
Most published SAE reconciliation guidance stops at four verbs: extract, compare, resolve, document.
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Expedited Safety Reporting in Clinical Trials: The Four-Gate Clock for SAEs, SUSARs, and IND Safety Reports
This guide is written for clinical-ops, PV/drug-safety associates, CRAs, and study-startup leads who own the safety-reporting SOP and need to know whether their day-zero definition and SUSAR classification would survive a BIMO or GCP inspection.
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Clinical Equipoise as a Monitorable Trial Condition: Who Owns It, When It Breaks, and What GCP Makes You Do
This guide is for clinical-ops staff, principal investigators, CRAs, and QA/regulatory readers who already know the textbook definition of equipoise and now have to make a protocol, a DSMB charter, and an amendment process actually hold it accountable.
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