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GCP Blog — Field notes from clinical research

July 2026 Edition

The Lead Story

The Lead
GCP10 min read

Choosing an eTMF System That Survives a GCP Inspection: A Sponsor's Defensibility Framework

The SERP for "best eTMF systems" is saturated with vendor-authored listicles that rank platforms by brand and feature count. That is the wrong instrument. An inspector does not audit your feature grid. They audit whether your essential records are present, filed on time, traceable, and retrievable, and whether the system holding them is validated and controlled. This guide reframes eTMF selection as a GCP-defensibility decision and gives you the criteria to evaluate candidates against the duties that ICH E6(R3), 21 CFR Part 11, and EMA's TMF archiving guidance actually impose.

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Recent dispatches

GCP

Screen Failure in Clinical Trials: How to Calculate the Rate, Document It Under GCP, and Read It as a Critical-to-Quality Signal

A high screen-failure rate gets framed as a recruitment cost to "reduce." That framing misses the two things an inspector actually cares about: whether every screened subject is documented, and whether consent preceded every procedure.

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GCP

There Is No FDA IND Database: What You Can Actually Look Up, and How the Form-1571 IND Clock Really Works

If you searched for an "FDA IND database," you were probably expecting something like ClinicalTrials.gov: a public registry where you type a drug or a company and pull up the application.

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GCP

IRB Approval, Decoded: Pick Your Review Tier Before You Submit (Exempt, Expedited, or Full Board)

Stop thinking of the IRB as a rubber stamp on your ethics.

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GCP

Types of Audits in Clinical Trials: A Risk-Mapped Framework for Inspection Readiness

A practitioner being told to "get audit-ready" usually gets handed a glossary: internal, external, regulatory.

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GCP

Clinical Trial Registration on ClinicalTrials.gov: The Two Questions and Three Clocks That Decide Your Deadline

Most registration mistakes are not data-entry errors.

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GCP

TMF vs ISF: An Ownership-and-Reconciliation Contract, Not a Location Table

Almost every explainer you will find stops at "TMF = sponsor, ISF = site." That is true and nearly useless, because it answers the wrong question.

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GCP

CAPA in Clinical Trials: The Four-Gate Workflow That Closes a Finding and Keeps It Closed

CAPA stands for Corrective And Preventive Action.

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GCP

Electronic Data Capture Software: The Four GCP and Part 11 Obligations That Decide Whether 'Compliant' Survives an Inspection

Most EDC evaluations go wrong in the same place: the demo.

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GCP

ICH GCP After E6(R3): What the July 2025 Standard Requires Now, and How It Maps to FDA 21 CFR 312

ICH GCP is the International Council for Harmonisation's Guideline for Good Clinical Practice: an international, ethical, scientific, and quality standard for the conduct of trials that involve human participants.

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The archive

77 pieces

The Trial Master File Checklist That Survives an Inspection: Completeness, Timeliness, and Quality Over a Document List

Central vs. Local IRB: What a Reliance Agreement Moves, and the GCP Duties It Can Never Transfer

Vulnerable Populations in Clinical Research: A Triage-and-Safeguard Playbook (Not a List to Memorize)

Drug Accountability in Clinical Trials: Closing the Custody Chain Before the Inspector Opens the Log

From Word Template to Defensible Essential Document: Making an Informed Consent Form GCP-Compliant

Clinical Research Coordinator Responsibilities: A Delegation-Mapped Guide to Staying In Scope for an FDA Inspection

Remote Monitoring in Clinical Trials: An RBQM Method That Survives an Inspection, Not a COVID Stopgap

Medical Monitor Responsibilities in Clinical Trials: The Four Safety Decisions, Their Reporting Clocks, and the Records That Prove Them

FDA DSUR Guidance: The DIBD-Anchored Annual Filing That Consolidates Your IND Annual Report (Not a Template)

Protocol Feasibility Assessment as an ICH E8 Quality-by-Design Gate: Run It on the Draft, Before Lock

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

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

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

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

Risk-Based Quality Management (RBQM) Under ICH E6(R3): Quality Designed In, Not Inspected In

The Clinical Study Report (CSR): ICH E3 Structure as a Reasoning Framework

The Clinical Monitoring Plan: A Risk-Based Blueprint, Not a Visit Schedule

SUSAR Reporting: Suspected, Unexpected, Serious, and the Clocks That Follow

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