GCP Blog — Field notes from clinical research
June 2026 Edition 64 pieces in print
Recent dispatches
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Risk-Based Quality Management (RBQM) Under ICH E6(R3): Quality Designed In, Not Inspected In
A common misread treats "risk-based" as a monitoring style.
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The Clinical Study Report (CSR): ICH E3 Structure as a Reasoning Framework
A clinical study report exists so that someone who was not there can rebuild the study and judge it.
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The Clinical Monitoring Plan: A Risk-Based Blueprint, Not a Visit Schedule
The instinct is to treat the monitoring plan as a schedule: visit every site every six weeks, check everything.
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SUSAR Reporting: Suspected, Unexpected, Serious, and the Clocks That Follow
SUSAR stands for suspected unexpected serious adverse reaction, and the name is the definition.
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Informed Consent in Clinical Trials: A Continuous Process, Not a Signature
The most common conceptual error in consent is treating the signed form as the event.
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Source Data Verification (SDV): Targeted, Risk-Based, and Paired With Source Data Review
Source data verification is the act of confirming that the data recorded in the study system, typically the eCRF, accurately reflect the original source record.
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Form FDA 1572: The Investigator's Binding Commitment, Not a Form-Fill
Form FDA 1572 is the mechanism by which a sponsor secures, in writing, an investigator's qualification and commitment before that investigator touches an IND study.
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Adverse Event and SAE Reporting in Clinical Trials: One Decision Tree, Two Reporting Tracks
The most expensive mistake in safety reporting is treating "serious" as a judgment of how bad an event felt.
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ALCOA and ALCOA+ Data Integrity in Clinical Trials: What the Acronym Actually Requires
ALCOA is the acronym FDA uses to define the attributes of trustworthy data.
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