SOP for CTN and CTX Scheme Management and Notifications

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Published on 22/12/2025

CTN and CTX Scheme Management and Notifications SOP

Department	Clinical Research
SOP No.	CS/TGA-CTN-CTX/173/2025
Supersedes	N.A.
Page No.	1 of 24
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Table of Contents

Purpose

This SOP establishes the processes for Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) submissions, management, and notifications to the Therapeutic Goods Administration (TGA). It ensures sponsor and investigator responsibilities are defined, submissions are accurate and timely, and clinical trials remain compliant with GCP and Australian regulatory requirements.

Scope

This SOP applies to all clinical trials under the CTN or CTX scheme where the organization is sponsor or delegated sponsor. It covers preparation, submission, acknowledgment, notifications, amendments, site-specific assessments, and ongoing compliance obligations. It applies to Regulatory Affairs, Clinical Research, Pharmacovigilance, Quality Assurance, and Investigator Sites involved in CTN/CTX processes.

Responsibilities

Regulatory Affairs (RA): Manages CTN/CTX submission preparation, lodgment, and notifications to TGA.
Principal Investigator (PI): Provides site-specific documents and ensures site compliance with authorized protocol.
Clinical Project Manager (CPM): Coordinates submissions, timelines, and REB/HREC approvals.
Pharmacovigilance (PV): Ensures safety reports are submitted to TGA as required under CTN/CTX obligations.
Quality Assurance (QA): Audits CTN/CTX processes and verifies compliance for inspection readiness.

Accountability

The Head of Clinical Research is accountable for overall compliance with CTN/CTX obligations. Regulatory Affairs is accountable for submission accuracy and timeliness. The PI is accountable for ensuring trial conduct at site level is consistent with approved CTN/CTX conditions.

Procedure

1. Determination of CTN vs CTX Pathway

Assess whether the investigational product and trial design require CTN (notification scheme) or CTX (exemption scheme requiring TGA evaluation).
Document rationale for pathway selection in Regulatory Justification Memo.

2. Preparation of Submission

Compile core documents: protocol, Investigator’s Brochure (IB), informed consent forms (ICFs), CMC data, and ethics approval certificates.
For CTN: Prepare notification package for TGA submission.
For CTX: Prepare full dossier including preclinical and clinical data for TGA evaluation.

3. Submission Process

Submit CTN/CTX via TGA online portal.
Record acknowledgment, submission ID, and control number in Regulatory Submission Log.
File submission package and acknowledgment in TMF.

4. Amendments

Submit substantial amendments to TGA prior to implementation (e.g., protocol changes, safety updates).
Update Amendment Log and inform sites and HRECs of approvals.

5. Notifications and Lifecycle Management

Notify TGA of trial initiation, site activations, suspensions, and trial closure.
Maintain Trial Notification Log capturing submission dates and acknowledgments.

6. Safety Reporting

Submit SUSARs, safety updates, and DSURs in compliance with TGA timelines.
Maintain Safety Reporting Log and SUSAR Submission Log in TMF.

7. Documentation and Archiving

Maintain Regulatory Submission Log, Amendment Log, Safety Reporting Log, and Communication Log in TMF.
Archive documents for at least 15 years or per TGA requirements.

Abbreviations

CTN: Clinical Trial Notification
CTX: Clinical Trial Exemption
TGA: Therapeutic Goods Administration
HREC: Human Research Ethics Committee
IB: Investigator’s Brochure
ICF: Informed Consent Form
CMC: Chemistry, Manufacturing, and Controls
PV: Pharmacovigilance
QA: Quality Assurance
TMF: Trial Master File

Documents

Regulatory Submission Log (Annexure-1)
Amendment Log (Annexure-2)
Trial Notification Log (Annexure-3)

References

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: Regulatory Submission Log

Date	Submission Type	Protocol No.	Submission ID	Status	Submitted By
05/08/2025	CTN Initial	AUS-2025-01	TGA-CTN-001	Acknowledged	Rajesh Kumar

Annexure-2: Amendment Log

Date	Amendment	Summary of Change	Status	Submitted By
18/09/2025	Amendment 1	Updated dose escalation scheme	Under Review	Sunita Reddy

Annexure-3: Trial Notification Log

Date	Activity	Protocol No.	Notification ID	Status	Owner
25/09/2025	Trial Initiation	AUS-2025-01	TGA-NTF-010	Acknowledged	Neha Sharma

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for CTN and CTX scheme management and notifications.	New SOP created for compliance with TGA requirements.	Head of Clinical Research

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