(PI): Evaluates reasons for dropout, determines medical/safety actions, and approves replacement.

Clinical Research Coordinator (CRC): Records dropout details, informs relevant departments, and ensures replacement eligibility.

QA Officer: Verifies documentation and protocol deviation records, if applicable.

Biostatistician: Confirms if replacements are statistically justified as per protocol.

4. Accountability

The PI and Clinical Operations Manager are accountable for ensuring timely documentation of dropouts, subject safety, and adherence to regulatory requirements during replacements.

5. Procedure

5.1 Definition of Dropout

1. A volunteer who:
   • Withdraws consent at any point
   • Is withdrawn due to safety reasons
   • Fails to comply with study procedures
2. All dropouts must be documented in Annexure-1: Subject Dropout Log.

5.2 Documentation and Notification

1. Immediately document the dropout reason in:
   • Source documents
   • CRF
   • Annexure-2: Dropout Summary Form
2. Notify QA, Sponsor (if applicable), and IEC if dropout impacts study data or safety.

5.3 Safety Assessment and Follow-Up

1. PI evaluates any AE/SAE prior to or at the time of dropout.
2. Provide medical attention if needed and document in AE/SAE forms.
3. Ensure volunteer is debriefed and thanked for participation.

5.4 Eligibility and Selection of Replacement

1. Replacement is allowed only if:
   • Permitted by protocol
   • Dropout occurred before dosing or before key PK assessments
2. New subject must:
   • Be fully screened and consented
   • Meet inclusion/exclusion criteria
   • Be assigned a new Volunteer ID (Annexure-3)

5.5 Data Management and Reporting

1. Update:
   • Volunteer Screening Log
   • Randomization list (if applicable)
   • Clinical Trial Master File
2. Report in protocol deviation log if the dropout deviates from expected study procedures.

5.6 Statistical and Regulatory Considerations

1. Ensure that replacements do not exceed allowed sample size.
2. Update biostatistics and PK teams regarding final evaluable set.
3. Include a section in the Clinical Study Report detailing dropouts and replacements.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• AE: Adverse Event
• SAE: Serious Adverse Event
• CRF: Case Report Form

7. Documents

1. Subject Dropout Log – Annexure-1
2. Dropout Summary Form – Annexure-2
3. Replacement Subject Tracking Sheet – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Indian GCP Guidelines
• Schedule Y – Drugs and Cosmetics Rules
• Approved Study Protocol

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Subject Dropout Log

Volunteer ID	Date of Dropout	Reason	Action Taken	Approved By
VOL-107-008	15/04/2025	Withdrew Consent	Documented and Debriefed	PI

Annexure-2: Dropout Summary Form

Volunteer ID	Study Phase	Reason for Dropout	Medical Follow-up Required	Notified To
VOL-107-008	Pre-dosing	Refused to Continue	No	QA, Sponsor

Annexure-3: Replacement Subject Tracking Sheet

Original Subject ID	Replacement ID	Replacement Date	Screening Date	Approved By
VOL-107-008	VOL-107-015	16/04/2025	14/04/2025	PI

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial SOP	Regulatory Compliance	QA Head
17/04/2025	2.0	Expanded Annexures, Clarified Replacement Criteria	Audit Finding	QA Head