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“headline”: “SOP for CTN and CTX Scheme Management and Notifications”,
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“description”: “Comprehensive SOP describing sponsor and investigator obligations for CTN and CTX scheme management, submission and notification procedures, and compliance with TGA GCP requirements.”,
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“datePublished”: “2025-08-28”,
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CTN and CTX Scheme Management and Notifications SOP

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

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

2. Preparation of Submission

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

3. Submission Process

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

4. Amendments

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

5. Notifications and Lifecycle Management

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

6. Safety Reporting

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

7. Documentation and Archiving

1. Maintain Regulatory Submission Log, Amendment Log, Safety Reporting Log, and Communication Log in TMF.
2. 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

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

References

• TGA — Clinical Trials Guidance
• ICH E6(R2) Good Clinical Practice
• NHMRC Human Research Ethics Committees

Version: 1.0

Approval

Annexures

Annexure-1: Regulatory Submission Log

Annexure-2: Amendment Log

Annexure-3: Trial Notification Log

Revision History

For more SOPs visit: Pharma SOP.