3. Responsibilities

• Clinical Monitor: Plans and conducts monitoring visits, verifies source data, reviews study documentation, and writes monitoring reports.
• Clinical Site Staff: Facilitates access to study documents and coordinates subject data verification.
• Principal Investigator (PI): Ensures site readiness and addresses findings from monitoring visits.

4. Accountability

The Study Director is accountable for ensuring all monitoring visits are properly scheduled, conducted, reported, and any findings are resolved within timelines.

5. Procedure

5.1 Types of Monitoring Visits

1. Pre-Study Visit (PSV): To assess the facility’s qualifications and readiness.
2. Study Initiation Visit (SIV): To train staff, confirm regulatory documents, and assess readiness.
3. Interim Monitoring Visit (IMV): To verify source data, IMP accountability, and protocol compliance.
4. Close-Out Visit (COV): To ensure all documents are complete, IMP is returned/destroyed, and study is closed properly.

5.2 Planning and Communication

1. Schedule visits in coordination with site staff and document in Annexure-1: Visit Calendar.
2. Prepare checklist of objectives using Annexure-2: Monitoring Visit Checklist.
3. Send confirmation email with agenda and required documents.

5.3 Conducting the Visit

1. Verify the following during the visit:
   • Informed consent process
   • Source data and CRF entries
   • IMP storage, dispensing, and accountability
   • Adverse event reporting and documentation
   • Site staff training records and protocol adherence
2. Discuss preliminary findings with site team at end of visit.

5.4 Documentation

1. Prepare Annexure-3: Monitoring Visit Report within 5 working days of the visit.
2. Log all findings and required actions in Annexure-4: Monitoring Findings Log.
3. Send the final report to QA, sponsor, and PI.

5.5 Follow-up and Resolution

1. Track resolution of all findings within defined timelines.
2. Document closure of findings in Annexure-5: Monitoring Resolution Log.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRF: Case Report Form
• IMP: Investigational Medicinal Product
• QA: Quality Assurance
• PI: Principal Investigator

7. Documents

1. Visit Calendar – Annexure-1
2. Monitoring Visit Checklist – Annexure-2
3. Monitoring Visit Report – Annexure-3
4. Monitoring Findings Log – Annexure-4
5. Monitoring Resolution Log – Annexure-5

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• Sponsor Monitoring Plan

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Visit Calendar

Visit Type	Date	Planned Activities	Monitor
SIV	18/04/2025	Site training, IMP check	Sunita Reddy

Annexure-2: Monitoring Visit Checklist

Activity	Completed	Remarks
Informed Consent Verification	Yes	ICFs available

Annexure-3: Monitoring Visit Report

Visit Date	Study Code	Monitor	Summary
18/04/2025	BE/2025/005	Sunita Reddy	No major deviations observed

Annexure-4: Monitoring Findings Log

Observation	Category	Action Required	Due Date
IMP temperature log incomplete	Minor	Retrain staff	20/04/2025

Annexure-5: Monitoring Resolution Log

Observation	Resolved Date	Corrective Action	Verified By
IMP temperature log	19/04/2025	Corrected and re-trained staff	QA Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial SOP	Monitoring setup	QA Head
17/04/2025	2.0	Annexures added, types of visits defined	Operational Enhancement	QA Head