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GCP Blog — Field notes from clinical research

July 2026 Edition

The Lead Story

The Lead
GCP10 min read

FDA 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. That is the easy 20 percent. The part that actually causes filings to slip or get rejected is operational: setting and protecting one anchor date, hitting one annual deadline, and keeping a clear line between what the DSUR aggregates and what your expedited safety reports already handled. This guide leads with that.

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Recent dispatches

GCP

Protocol 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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GCP

Clinical Trial Terminology, Grouped by Workflow and Stamped to ICH E6(R3) (2025)

Flat glossaries answer "what does this word mean" but not "when does it matter and which definition is current." This reference fixes both.

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GCP

Clinical Trial Sponsor Responsibilities: The Non-Delegable Oversight System Under ICH E6(R3)

If you run trials through a contract research organization (CRO), the single most expensive misunderstanding you can carry is this one: that outsourcing a task also outsources the accountability for it.

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GCP

The Clinical Trial Agreement, Decoded: A Clause-by-Clause Negotiator's Playbook for the GCP Duties You Cannot Sign Away

The CTA is where the abstract obligations of Good Clinical Practice become contractually enforceable promises between named parties.

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GCP

The Delegation of Authority Log: Who Did What, and Whether They Were Qualified To

A clinical trial is run by a team, but the regulations hold one person answerable for it.

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GCP

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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GCP

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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GCP

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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GCP

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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The archive

59 pieces

Informed Consent in Clinical Trials: A Continuous Process, Not a Signature

Source Data Verification (SDV): Targeted, Risk-Based, and Paired With Source Data Review

Form FDA 1572: The Investigator's Binding Commitment, Not a Form-Fill

Adverse Event and SAE Reporting in Clinical Trials: One Decision Tree, Two Reporting Tracks

ALCOA and ALCOA+ Data Integrity in Clinical Trials: What the Acronym Actually Requires

The Trial Master File (TMF): An Inspection-Ready System, Not a Document Checklist

Protocol Deviations in Clinical Trials: Classify, Report, and Prevent Under ICH E6(R3)

Clinical Trial Budget Management: Building Compliant, Efficient Budgets in the ICH E6(R3) Era

Clinical Trial Delays Cost Prevention: Reducing Timeline Risk Without Compromising Compliance

Clinical Trial Milestones: Navigating FDA and ICH Regulatory Checkpoints for Successful Trial Execution

Audit Trail Requirements FDA 21 CFR Part 11 Clinical Research: What Regulators Expect and Why It Matters

Clinical Trial Management Guidelines: Applying FDA and ICH E6(R3) Standards for Modern, Risk-Based Trial Execution

Clinical Trial Project Management Challenges: Overcoming Regulatory Complexity, Enrollment Barriers, and Operational Risk

Clinical Study Startup Checklist: FDA and ICH E6(R3) Requirements to Prevent Costly Trial Delays

GCP SOP Template Clinical Trial Documentation ICH E6(R3): Building Compliant, Risk-Based SOPs for Modern Trials

Clinical Trial Project Management Guidelines: ICH GCP and FDA Requirements

ICH E6(R3) GCP Guidelines for Clinical Trials

Clinical Trial Compliance GCP Regulatory Guidelines: How to Meet FDA and ICH E6(R3) Expectations Without Derailing Your Study

CTMS Clinical Trial Management System Regulatory Compliance: Meeting FDA and 21 CFR Part 11 Requirements with Confidence

Clinical Trial Closeout Procedures: Ensuring FDA and ICH E6(R3) Compliance While Protecting Long-Term Data Integrity

CTMS vs EDC: Key Differences for Clinical Trial Management Teams

ICH E6(R3) Clinical Trial Risk Management Framework

FDA Clinical Trial Phases I II III IV Regulatory Guidance

Clinical Trial Compliance: Navigating ICH E6(R3) GCP Requirements in a Risk-Based Regulatory Era

CTMS and EDC Comparison as Clinical Data Management Systems

Vendor Management Clinical Trials CRO Oversight: Meeting FDA Expectations While Maintaining Control and Accountability

Clinical Site Selection Feasibility Checklist: FDA and ICH E6(R3) Criteria to Prevent Delays and Compliance Risk

ICH E6(R3) GCP Guidelines FDA EMA Implementation

Site Initiation Visit Checklist

Clinical Project Management GCP Pharmaceutical Research Guidelines

Clinical Trial Vendor Management: CRO Oversight and FDA Guidance

Clinical Trial Risk Management ICH E6(R3) Framework

FDA 21 CFR Part 11 Audit Trail Requirements Compliance

Site Initiation Visit Checklist GCP FDA Guidance

Clinical Trial Phases Lifecycle FDA ICH E6 Guidance

Clinical Trial Sponsor Oversight Responsibilities

Clinical Trial Team Roles Responsibilities GCP Guidelines

ICH E6 GCP Guidelines for Clinical Trials

Clinical Trial Startup FDA ICH E6 GCP Requirements

FDA 21 CFR Part 11 Electronic Records Software Compliance Guidance

Investigator Initiated Trials IIT Management

The Importance of Good Clinical Practice in Real-World Evidence Studies

The Role of Ethics in Clinical Trials: A Deep Dive

Overcoming Common GCP Compliance Challenges in Clinical Research

The Role of Good Clinical Practice in Pediatric Clinical Trials

The Role of Technology in Streamlining GCP Compliance and Clinical Trial Management

Mastering GCP Compliance: Top Tips for Clinical Trial Sites

Risk-Based Monitoring in Good Clinical Practice: An Innovative Approach

How to Ensure Data Integrity in Clinical Research

Navigating Patient Rights and Safety in Clinical Studies

Understanding the Principles of GCP

Good Clinical Practice in the Era of Remote and Decentralized Clinical Trials

Introduction to ICH E6 Good Clinical Practice Guidelines

Breaking Down the Elements of Informed Consent

The Importance of Protocol Compliance in Clinical Trials

Essential Documents in Good Clinical Practice: A Comprehensive Guide

Establishing GCP Compliance in Clinical Research Organizations

The Evolution of Good Clinical Practice Guidelines A Historical Overview

Data Quality and Good Clinical Practice