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
Protocol/ICF amendments require IRB/IEC approval before implementation (except for immediate safety changes), tracked here and in the deviation/issue logs (QA-DEV/QA-ISSUE).