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“headline”: “SOP for Handling Subject Withdrawals and Dropouts in Clinical Trials”,
“description”: “This SOP outlines the process for managing subject withdrawals and dropouts in clinical trials, ensuring ethical compliance, participant safety, and regulatory adherence under ICH GCP, FDA, EMA, CDSCO, and WHO guidelines.”,
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Published on 22/12/2025
Standard Operating Procedure for Handling Subject Withdrawals and Dropouts
| Department | Clinical Research |
| SOP No. | CR/SUB/028/2025 |
| Supersedes | NA |
| Page No. | 1 of 22 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define the procedures for handling participant withdrawals and dropouts during clinical trials. This ensures that participant rights are
Scope
This SOP applies to all clinical research staff including investigators, sub-investigators, study coordinators, and sponsor/CRO staff responsible for trial oversight. It covers voluntary withdrawals, investigator-initiated withdrawals for safety reasons, and subject dropouts due to non-compliance or loss to follow-up.
Responsibilities
- Principal Investigator (PI): Ensures participant withdrawal requests are respected and documented.
- Study Coordinator: Updates subject status in Subject Withdrawal Log and communicates with sponsor.
- Investigators: Assess safety of participants during withdrawal and provide necessary medical follow-up.
- Sponsor/CRO: Tracks withdrawals and evaluates impact on study integrity.
- Quality Assurance Officer: Verifies withdrawal documentation during audits.
Accountability
The PI is accountable for ethical handling of participant withdrawals and for ensuring documentation is complete and accurate. Sponsors are accountable for monitoring dropout rates and their potential impact on trial validity.
Procedure
1. Voluntary Withdrawal
Participants may withdraw consent at any time without penalty.
Document withdrawal in writing using the Subject Withdrawal Form (Annexure-1).
Update Subject ID Log and Withdrawal Log accordingly.
2. Investigator-Initiated Withdrawal
PI may withdraw a participant if continuation poses safety risks.
Provide appropriate medical follow-up and record rationale.
Inform EC/IRB of safety-related withdrawals as required.
3. Dropouts
Record dropouts due to non-compliance, lost-to-follow-up, or other reasons.
Document all attempts to contact the participant.
4. Data Handling
Retain data collected up to the point of withdrawal as per regulatory guidance.
Clearly mark datasets for withdrawn participants in study records.
5. Communication
Notify sponsor/CRO of withdrawal or dropout within specified timelines.
Report significant withdrawals to regulatory authorities if required.
6. Archiving
File withdrawal forms and logs in ISF and TMF.
Retain documentation for at least 5 years post-trial or as per local requirements.
Abbreviations
- SOP: Standard Operating Procedure
- PI: Principal Investigator
- CRO: Clinical Research Organization
- ISF: Investigator Site File
- TMF: Trial Master File
- EC: Ethics Committee
- IRB: Institutional Review Board
Documents
- Subject Withdrawal Form (Annexure-1)
- Subject Withdrawal Log (Annexure-2)
- Subject Dropout Tracking Form (Annexure-3)
References
- ICH E6(R2) – Good Clinical Practice
- US FDA – Clinical Trial Guidance
- EMA Clinical Trial Regulation
- CDSCO Clinical Trial Rules, 2019
- WHO – Ethical Guidelines for Clinical Research
Version: 1.0
Approval Section
| Prepared By | Rajesh Kumar, Clinical Research Coordinator |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Principal Investigator |
Annexures
Annexure-1: Subject Withdrawal Form
| Date | Subject ID | Reason for Withdrawal | Signature of Subject/Guardian | Investigator Signature |
|---|---|---|---|---|
| 12/09/2025 | CT2025-SITE01-012 | Personal choice | Signed | Dr. Meera Joshi |
Annexure-2: Subject Withdrawal Log
| Date | Subject ID | Withdrawal Type | Notified To | Recorded By |
|---|---|---|---|---|
| 13/09/2025 | CT2025-SITE01-013 | Investigator-initiated | Sponsor, EC | Ravi Kumar |
Annexure-3: Subject Dropout Tracking Form
| Date | Subject ID | Reason for Dropout | Attempts to Contact | Status |
|---|---|---|---|---|
| 15/09/2025 | CT2025-SITE01-015 | Lost to follow-up | 3 phone calls, 1 letter | Unreachable |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head, Clinical Research |
For more SOPs visit: Pharma SOP