at the clinical research facility.

3. Responsibilities

• Clinical Research Coordinator (CRC): Organizes and oversees mock run activities at the clinical site.
• Bioanalytical Coordinator: Verifies readiness of sample processing and storage logistics.
• QA Officer: Observes and documents compliance and deviations during the mock run.
• Study Director: Reviews findings and implements necessary improvements.

4. Accountability

The Principal Investigator is accountable for ensuring that all critical study steps are simulated, reviewed, and validated prior to actual volunteer dosing.

5. Procedure

5.1 Planning the Mock Run

1. Prepare a mock run plan (Annexure-1) specifying:
   • Study code
   • Departments involved
   • Simulation activities (e.g., check-in, dosing, sample collection)
   • Start and end times
2. Inform all staff of the mock run date at least 48 hours in advance.

5.2 Execution of Mock Run

1. Conduct mock procedures using dummy volunteers or site staff, including:
   • Subject check-in and ID verification
   • Dosing simulation with placebo or labeled containers
   • Sample collection (dummy tubes)
   • Transport and processing simulation
2. Record data in Annexure-2: Mock Run Execution Log.

5.3 Monitoring and Documentation

1. QA Officer must observe critical steps and record compliance or deviations.
2. Any system failures, timing mismatches, or SOP gaps must be noted in Annexure-3: Mock Run Observation Report.

5.4 Post-Run Review

1. Conduct a debriefing meeting with all stakeholders to:
   • Discuss observations
   • Identify corrective actions
   • Update SOPs if necessary
2. Study Director shall prepare Annexure-4: Mock Run Closure Summary for final documentation.

5.5 Readiness Confirmation

1. Only upon successful completion of the mock run and closure of critical findings shall the study proceed to actual volunteer enrollment and dosing.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. Mock Run Plan – Annexure-1
2. Mock Run Execution Log – Annexure-2
3. Mock Run Observation Report – Annexure-3
4. Mock Run Closure Summary – Annexure-4

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs & Cosmetics Rules
• 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: Mock Run Plan

Study Code	Departments Involved	Date	Planned Activities	Coordinator
BE/2025/004	Clinical, Pharmacy, Bioanalytical	18/04/2025	Simulated Check-in, Dosing, Sampling	Sunita Reddy

Annexure-2: Mock Run Execution Log

Time	Activity	Performed By	Remarks
08:00	Volunteer Check-In	Ravi Nair	On Schedule

Annexure-3: Mock Run Observation Report

Step Observed	Observation	Deviation Noted	QA Comment
Sample Labeling	Incomplete sticker on 1 tube	Yes	Label SOP needs revision

Annexure-4: Mock Run Closure Summary

Mock Run Date	Study Code	Outcome	Final Reviewer	Action Plan
18/04/2025	BE/2025/004	Successful	Dr. Arvind Shah	Label template updated

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial SOP Release	Study Readiness Process	QA Head
17/04/2025	2.0	Annexures added and expanded observation reporting	Regulatory Compliance	QA Head