📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.

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Mock / simulation document

This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.

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About this document — a plain-language guide

What it is. The Clinical Trial Agreement (CTA) and the IRB/IEC approval tracker.

Why it exists. A trial cannot start at a site until contracts are signed and an ethics committee approves. This captures the site agreement terms and tracks ethics approvals — essential documents under GCP.

How it is produced here. It is an operational trial document — a plan, charter, or template of the kind kept in the Trial Master File. It describes how the trial is run, rather than reporting the trial's results.

Format & governing standard. ICH E6(R3) essential documents

Clinical Trial Agreement (CTA) & IRB/IEC Approval Tracker — GLPI103-301

Field	Value
Document ID	TMF-CTA
Study No.	GLPI103-301
Version	1.0
Standard	ICH E6(R3) essential documents
Confidentiality	Confidential — TMF

Template key terms for the site Clinical Trial Agreement and a tracker for ethics/regulatory approvals. [MOCK] identifiers.

Change History

Version	Date	Author	Summary
1.0	2026-06-29	Clinical Operations / Legal	Initial CTA & IRB tracker

1. Clinical Trial Agreement — Key Terms

Clause	Summary
Parties	Sponsor (Virtual Biopharma Inc.), Institution, Principal Investigator
Scope	Conduct of GLPI103-301 per protocol PROT-301 and GCP
Budget & payments	Per-subject and milestone payments; pass-through costs (PM-003)
Responsibilities	Sponsor oversight (ICH E6(R3)); site conduct, source records, GCP training
IP & publication	Data ownership; publication rights per sponsor policy (multicenter primary publication first)
Confidentiality & data protection	Subject privacy; applicable law
Indemnification & insurance	Sponsor clinical-trial insurance; subject-injury coverage
Term & termination	Duration; termination for cause; record retention

2. Ethics & Regulatory Approval Tracker (illustrative)

Site	IRB/IEC	Protocol PROT-301 v2.0	ICF (TMF-ICF)	Local reg. approval	Status
S001 (Capital)	Central/Local IRB	Approved `[MOCK]`	Approved	IND/CTA on file	Active
S002–S017	per site	Approved	Approved	on file	Active

3. Essential Documents Maintained (per site)

Signed CTA; IRB/IEC approval & composition; approved protocol & amendments; approved ICF versions; investigator CV & medical license; FDA Form 1572 (US) / equivalent; financial disclosure (3454/3455); laboratory certification & normal ranges; delegation log; training records. Filed and version-controlled in the TMF (TMF-IDX).

4. Amendments