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Standard Operating Procedure for Handling Subject Withdrawals and Dropouts

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 respected, safety is prioritized, and data integrity is maintained while complying with applicable ethical and regulatory guidelines.

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Clearly mark datasets for withdrawn participants in study records.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

1. Subject Withdrawal Form (Annexure-1)
2. Subject Withdrawal Log (Annexure-2)
3. 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

Annexures

Annexure-1: Subject Withdrawal Form

Annexure-2: Subject Withdrawal Log

Annexure-3: Subject Dropout Tracking Form

Revision History

For more SOPs visit: Pharma SOP