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GCP Blog — Field notes from clinical research

November 2026 Edition

The Lead Story

The Lead
GCP13 min read

Pre-IND meeting: how to request it and write questions that head off a clinical hold

A pre-IND meeting is the sponsor's chance to put its development plan in front of the FDA review division before the IND is filed. Thirty days after FDA receives an IND, the investigations either may begin or are on clinical hold, and the meeting is where a sponsor can find out in advance which parts of the plan FDA would object to. This guide separates the regulation from FDA guidance, then covers the request, the questions and the briefing package.

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Recent dispatches

GCP

Form FDA 1571: what you certify each time you sign the IND cover sheet

Form FDA 1571 is the Investigational New Drug Application form: the signed cover sheet a sponsor puts on the front of an IND submission to FDA.

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GCP

21 CFR 312: a map of the IND regulation, subpart by subpart

21 CFR 312 is the FDA regulation for investigational new drug applications (INDs).

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GCP

Clinical Trial Timelines: A GCP Milestone Model for Planning Around the Months You Actually Lose

Most "how long does a clinical trial take" pages give you a phase-duration table and stop.

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GCP

Patient Recruitment in Clinical Trials: A GCP Compliance Guide to Ads, Inducement, Pre-Screening, and Consent Timing

Most "how to improve recruitment" content treats enrollment as a conversion problem: better channels, sharper messaging, loyalty for retention.

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GCP

Patient Retention in Clinical Trials: A GCP Quality Control, Not a Tip List

Most "patient retention in clinical trials" guides read like a customer-service checklist: set expectations, communicate often, reimburse travel, be person-centric.

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GCP

EU Clinical Trial Regulation 536/2014: The CTIS Submission Workflow, Assessment Clocks, and RFI Deadlines

This guide treats CTR 536/2014 the way a clinical-ops or regulatory-affairs reader actually meets it: as a sequence of portal actions and countdowns.

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GCP

The FDA Form 483 Response for Clinical Sites and Sponsors: A 15-Day Playbook and Year-Round Inspection-Readiness Guide

The clinical-site internet has a problem: nearly every "how to respond to a 483" page is written for a drug-manufacturing plant.

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GCP

ICH E9 for Non-Statisticians: The Operational Contract That Locks Your Trial's Question Before Unblinding

For clinical-ops, CRAs, data managers, and QA staff, the most useful way to read ICH E9 is operational, not mathematical.

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GCP

Clinical Study Report vs. ClinicalTrials.gov Results: Two Deliverables, Two Clocks, and How to Pick the Right CSR Format

If your team has ever posted summary results to ClinicalTrials.gov, breathed out, and assumed end-of-study reporting was finished, this article is for you.

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The archive

112 pieces

ICH E3 Clinical Study Report Template: Pick the Tier First, Then Defend the Section Map

FDA BIMO Inspection Prep: An Oversight Stress-Test, Not a Binder Checklist

The FDA IND Application as a Three-Pillar Safety Dossier: 21 CFR 312.23 Contents, the 30-Day Clock, and the Sponsor-Investigator Traps That Trigger a Clinical Hold

ICH E8(R1) in Practice: Turning Critical-to-Quality Factors into Risk-Proportionate Controls and an E6(R3) RBQM Hand-off

MHRA GCP Inspection Findings as a Risk Map: Map the Recurring Themes to ICH E6(R3) and Self-Inspect Before They Cite You

GCP Audit Checklist: Two Lists, Not One — Site (BIMO) vs. Vendor/CRO, Graded by Subject Protection and Data Integrity

The Visit-Type-Aware Clinical Trial Monitoring Visit Checklist: SQV, SIV, IMV, COV, and Inspection Prep, Mapped to GCP

Clinical Trial Audits: The Independent, Risk-Triggered QA Instrument (Not Monitoring, Not an Inspection)

Clinical Quality Assurance Under ICH E6(R3): Build Quality In, Don't Audit It At Lock

Root Cause Analysis in Clinical Trials: How to Reach a Systemic Cause Your CAPA Can Actually Prevent

Critical-to-Quality Factors: A Living QbD Spine, Not a Protocol Appendix

GCP record retention: how long to keep clinical trial records and the TMF

Quality Tolerance Limits in Clinical Trials: How to Set, Breach, and Document 3-5 QTLs Under ICH E6(R3)

Serious Adverse Event Definition: What Makes an Event Serious

Clinical trial close-out procedures: the close-out visit as a verification gate

Phase 1 Drug Manufacturing: Exempt From Part 211, Not From CGMP

Central Lab vs Local Lab: What Changes Regulatorily

Electronic Data Capture in Clinical Trials: The GCP Accountability the Vendor Cannot Take From You

Source Documents in Clinical Trials: The ALCOA+ Evidence Layer, Certified Copies, and Risk-Based SDV

Quality by Design in Clinical Trials: A Critical-to-Quality (CtQ) Identification Workflow, Not a Philosophy Lecture

The Living Data Management Plan: A Risk-Based DMP Template That Survives Database Lock and Inspection

Query Management in Clinical Data Management: A Closure-Clock Playbook for One-Round Resolution

The Investigator Site File as an Inspection-Ready Evidence System: Reconciling the ISF to the TMF, and the Four Failure Modes Inspectors Cite

GCP Training Requirements: A Currency Status With an Expiry Date, Not a One-Time Certificate

Clinical Trial Database Lock: The Auditable State Machine (Soft Lock, Hard Lock, and the Controlled Unlock)

Principal Investigator Responsibilities: The Non-Delegable Accountability Boundary Under ICH E6(R3) and 21 CFR 312

Randomization and Blinding in Clinical Trials: One Bias-Control Chain From Allocation to Emergency Unblinding

The Ethics Committee Relationship: What an IRB/IEC Must Approve Before Enrollment and the Four Duties That Keep Approval Alive

The IRB Approval Lifecycle: Keeping Approval Continuously Valid Through Continuing Review, Amendments, and the Lapse You Must Avoid

IRB Continuing Review for Greater-Than-Minimal-Risk Studies: The Annual Floor, the Expiration Cliff, and What Still Needs Renewing

IRB Waiver of Consent: Three Decisions, Five Criteria, and What the 2024 FDA Rule Changed

Informed Consent Form Template: Build an Inspection-Ready ICF from the Required-Elements Checklist (ICH E6(R3) / 21 CFR 50)

What is a DSMB? The data safety monitoring board explained

Pharmacovigilance in Clinical Trials: The Classify-Then-Clock Workflow for AE, SAE, and SUSAR Reporting

SAE Reconciliation: A Field-Level Discrepancy-Resolution Workflow That Closes Before Lock and Never Lags the SUSAR Clock

Expedited Safety Reporting in Clinical Trials: The Four-Gate Clock for SAEs, SUSARs, and IND Safety Reports

Clinical Equipoise as a Monitorable Trial Condition: Who Owns It, When It Breaks, and What GCP Makes You Do

Essential documents in clinical trials: the ICH E6(R3) list and the test behind it

The eTMF, Operationalized: Completeness, Timeliness, and Quality That Survive a GCP Inspection

The Clinical Research Coordinator as a GCP-Accountability Map: Which CRC Duties Carry Regulatory Weight Under ICH E6(R3) and 21 CFR 312

EDC, eCRF, eCOA and IWRS as One Regulated Data Flow: Who Owns the Source Record and Where ALCOA Breaks at the Seams

Clinical Trial Design and Management as One Quality-by-Design Chain: From Critical-to-Quality Factors to Risk-Based Oversight

Clinical Trial Site Monitoring: The Visit-Type Lifecycle (SSV, SIV, IMV, COV) and the SIV Enrollment Gate

The TMF Reference Model as a Tailoring Exercise: Mapping DIA/CDISC Zones to ICH E6(R3) Essential Records

Clinical Trial Close-Out Checklist: A Dependency-Gated Sequence Built on GCP and 21 CFR Part 312

The Monitoring Visit Report as Oversight Evidence: A GCP-Audit-Ready MVR, Not a Filled-In Form

Data Safety Monitoring Plan vs. Medical Monitoring Plan vs. DSMB Charter: Which One Your Trial Needs, Who Signs It, and How They Fit Together

Protocol Deviation Management: An Impact-Classified Triage-and-Timeline Workflow Under ICH E6(R3) and 21 CFR 312

Risk-Based Monitoring in Clinical Trials: What It Is and What FDA and ICH E6(R3) Expect

The Quality-by-Design Clinical Trial Protocol: Engineering Out Deviations with Critical-to-Quality Factors and a Defensible Schedule of Activities

The Protocol Deviation Log, Engineered: Columns, Classification, and the Timelines an Inspector Reads as Control

Clinical Trial Endpoints as a Pre-Locked Contract: Who May See Endpoint and Interim Data, When, and What Counts as a Deviation

CTMS vs eTMF: Which System Is the System of Record (and Why GCP Findings Live on That Boundary)

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

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

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

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

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

Clinical trial registration: who must register on ClinicalTrials.gov, and by when

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

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

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

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

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

Central vs local IRB: when single-IRB review is required and who owns what after you sign

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

What does a clinical research coordinator do? CRC duties and responsibilities

Remote Monitoring in Clinical Trials: Remote Site Monitoring Under ICH E6(R3) and FDA Guidance

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) in Clinical Trials: How the System Works Under ICH E6(R3)

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

What Is a Trial Master File (TMF)? Definition, Contents and the Test It Has to Pass

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

Clinical trial budget management: the lines GCP and FDA rules fix

Clinical trial delays: which ones you can prevent and the control that heads off each

Drug development milestones: the FDA and EU gates between clinical trial phases

Audit trail requirements in clinical trials: what Part 11 demands and the review regulators expect

Clinical trial project management: the challenges that are really sponsor obligations

Clinical study start-up checklist: what must be true before each step

Clinical research SOPs: which ones a sponsor or site needs, and why

ICH E6(R3): What the Standard Contains and How to Navigate It

What is a CTMS? Clinical trial management systems and regulatory compliance

Clinical trial phases I to IV: what FDA rules and ICH E8(R1) say each phase is for

CTMS vs EDC: which records each system owns and what breaks between them

CRO and vendor oversight: what 21 CFR 312.52 transfers, what the sponsor keeps, and the records that prove it

Clinical Trial Site Feasibility: A Demonstration, Not a Questionnaire

Site initiation visit checklist: the GCP obligation and evidence behind each item

Clinical trial team structure: who is accountable and who does the work under GCP

Investigator-Initiated Studies: The Sponsor Duties You Take On

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

Ethics in clinical trials: each principle and the provision that enforces it

Clinical Trial Data Integrity: Requirements at Every Stage of the Data Life Cycle

Principles of GCP: the definition of good clinical practice and the 11 ICH E6(R3) principles

The Elements of Informed Consent: What 21 CFR 50.25 Actually Requires

GCP Compliance: The Requirements and a Checklist of the Records That Prove Them

History of good clinical practice (GCP): a sourced timeline from Helsinki to E6(R3)

Data quality in clinical trials: what GCP means by fit for purpose