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“headline”: “SOP for Long-Term Follow-Up (LTFU) of ATMP Subjects”,
“description”: “This SOP outlines the standardized procedures for long-term follow-up (LTFU) of subjects in Advanced Therapy Medicinal Product (ATMP) trials, ensuring compliance with FDA, EMA, CDSCO, WHO, and ICH GCP requirements. It includes subject re-consent, monitoring, safety reporting, and data retention strategies.”,
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Published on 21/12/2025
Standard Operating Procedure for Long-Term Follow-Up (LTFU) of ATMP Subjects
| SOP No. | CR/OPS/113/2025 |
| Supersedes | NA |
| Page No. | 1 of 57 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define standardized procedures for the long-term follow-up (LTFU) of subjects
Scope
This SOP applies to sponsors, investigators, CROs, site staff, and regulatory affairs involved in ATMP trials. It covers subject re-consent, follow-up visits, safety reporting, data collection, data privacy, retention, regulatory submissions, and communication with subjects during extended follow-up.
Responsibilities
- Sponsor: Designs and funds LTFU programs, ensuring compliance with regional and international regulations.
- Investigator: Manages LTFU at site level, ensuring subject safety and documentation.
- CRO: Oversees monitoring and ensures adherence to LTFU requirements.
- Regulatory Affairs: Submits updates to authorities and ethics committees.
- QA: Audits LTFU records and ensures data integrity.
Accountability
The Sponsor’s Medical Director is accountable for overall LTFU compliance. The Principal Investigator is accountable for subject-level follow-up and re-consent.
Procedure
1. LTFU Planning
1.1 Develop an LTFU plan as part of the trial protocol.
1.2 Define follow-up duration (e.g., 5–25 years depending on ATMP type).
1.3 Record in LTFU Planning Log (Annexure-1).
2. Subject Re-Consent
2.1 Obtain re-consent if required by protocol or local regulations.
2.2 Document in Re-Consent Log (Annexure-2).
3. Follow-Up Visits
3.1 Schedule annual or protocol-defined follow-up visits.
3.2 Collect clinical, laboratory, and imaging data.
3.3 Document visits in Follow-Up Visit Log (Annexure-3).
4. Safety Reporting
4.1 Monitor delayed adverse events, malignancies, or gene integration effects.
4.2 Report per regulatory timelines to sponsor, EC/IRB, and regulators.
4.3 Document in LTFU Safety Log (Annexure-4).
5. Data Privacy and Retention
5.1 Ensure compliance with GDPR, HIPAA, and local privacy laws.
5.2 Retain records for minimum of 25 years for ATMPs in EU.
5.3 Record retention activities in Data Retention Log (Annexure-5).
6. Subject Communication
6.1 Provide regular updates and educational material to subjects.
6.2 Document communication in Subject Communication Log (Annexure-6).
7. Archiving
7.1 Archive all LTFU records in TMF and ISF.
7.2 Ensure accessibility for inspections and audits.
Abbreviations
- SOP: Standard Operating Procedure
- LTFU: Long-Term Follow-Up
- ATMP: Advanced Therapy Medicinal Products
- CRO: Contract Research Organization
- QA: Quality Assurance
- IRB/EC: Institutional Review Board/Ethics Committee
- GCP: Good Clinical Practice
- TMF: Trial Master File
- ISF: Investigator Site File
- GDPR: General Data Protection Regulation
- HIPAA: Health Insurance Portability and Accountability Act
Documents
- LTFU Planning Log (Annexure-1)
- Re-Consent Log (Annexure-2)
- Follow-Up Visit Log (Annexure-3)
- LTFU Safety Log (Annexure-4)
- Data Retention Log (Annexure-5)
- Subject Communication Log (Annexure-6)
References
- FDA – Long-Term Follow-Up for Cellular & Gene Therapy
- EMA – ATMP LTFU Guidelines
- CDSCO – ATMP Long-Term Monitoring
- ICH GCP – Follow-Up in ATMP Trials
- WHO – ATMP Long-Term Follow-Up Recommendations
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Medical Monitor |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: LTFU Planning Log
| Date | Study ID | Planned Duration | Prepared By | Status |
|---|---|---|---|---|
| 01/09/2025 | ATMP-LTFU-01 | 15 years | Regulatory Team | Completed |
Annexure-2: Re-Consent Log
| Date | Subject ID | Re-Consent Obtained | By Whom | Status |
|---|---|---|---|---|
| 02/09/2025 | S101 | Yes | Investigator | Signed |
Annexure-3: Follow-Up Visit Log
| Date | Subject ID | Visit Type | Performed By | Status |
|---|---|---|---|---|
| 05/09/2025 | S101 | Annual LTFU | Study Nurse | Completed |
Annexure-4: LTFU Safety Log
| Date | Subject ID | Event | Severity | Reported To |
|---|---|---|---|---|
| 06/09/2025 | S101 | Delayed AE: Leukopenia | Moderate | Sponsor + EC |
Annexure-5: Data Retention Log
| Date | Study ID | Retention Period | Archived By | Status |
|---|---|---|---|---|
| 10/09/2025 | ATMP-LTFU-01 | 25 years | QA Officer | Archived |
Annexure-6: Subject Communication Log
| Date | Subject ID | Mode | Summary | By Whom |
|---|---|---|---|---|
| 12/09/2025 | S101 | Phone | Explained follow-up schedule | Study Nurse |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Clinical Operations |
For more SOPs visit: Pharma SOP