the site close-out checklist and coordinates documentation retrieval.

Principal Investigator: Ensures completeness of study documentation and archiving.

QA Personnel: Reviews checklist completion and ensures regulatory compliance.

Project Manager: Ensures sponsor requirements for site closure are met.

4. Accountability

The Clinical Trial Manager is accountable for ensuring all elements of the close-out checklist are addressed and appropriately documented prior to formal site closure.

5. Procedure

5.1 Initiating Close-Out

1. Initiate close-out checklist once the last subject’s last visit (LSLV) and data collection are complete.
2. Notify site via formal communication using Annexure-1: Site Close-Out Notification Template.

5.2 Close-Out Checklist Preparation

1. Download and customize Annexure-2: Site Close-Out Checklist.
2. Checklist must include, at minimum:
   • Final subject log and accountability forms
   • Resolution of data queries and protocol deviations
   • Archiving of source documents and CRFs
   • Return or destruction of IP and unused materials
   • Verification of signed informed consent documents
   • Confirmation of SAE reports submission and closure

5.3 On-Site Close-Out Visit

1. Conduct the visit in the presence of the PI and study coordinator.
2. Verify:
   • All essential documents are in the Investigator Site File (ISF)
   • All subject-related documents are completed and signed
   • Storage conditions of archived documents are compliant
3. Document observations and pending actions in Annexure-3: Site Close-Out Visit Report.

5.4 Final Sign-Off and Archival

1. Review completed checklist and ensure no open action items remain.
2. PI and CRA must sign off Annexure-4: Site Close-Out Certification Form.
3. Archive all original documents at the site and send copies to sponsor/CRO.

5.5 Communication to Sponsor and Ethics Committee

1. Send formal notification of site closure to the sponsor and Institutional Ethics Committee (IEC) using Annexure-5.
2. Include summary of:
   • Subjects enrolled and completed
   • Adverse events reported
   • Final ISF content verification

6. Abbreviations

• CRA: Clinical Research Associate
• PI: Principal Investigator
• ISF: Investigator Site File
• CRF: Case Report Form
• IP: Investigational Product
• IEC: Institutional Ethics Committee

7. Documents

1. Site Close-Out Notification Template – Annexure-1
2. Site Close-Out Checklist – Annexure-2
3. Site Close-Out Visit Report – Annexure-3
4. Site Close-Out Certification Form – Annexure-4
5. Site Closure Communication to IEC/Sponsor – Annexure-5

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• CDSCO Inspection Checklist

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Site Close-Out Notification Template

Date	Site Name	Study Code	PI	Notification By
15/04/2025	ABC Clinical Unit	BE-128	Dr. Meena Joshi	Rajesh Kumar

Annexure-2: Site Close-Out Checklist

Task	Status	Remarks
All CRFs completed and signed	Yes	Verified by CRA
IP returned/destructed	Yes	Destruction Certificate filed

Annexure-3: Site Close-Out Visit Report

Date	CRA	PI	Summary of Activities
16/04/2025	Sunita Reddy	Dr. Meena Joshi	Documents verified, ISF archived

Annexure-4: Site Close-Out Certification Form

Site	PI Name	CRA Name	Certification Date
ABC Clinical Unit	Dr. Meena Joshi	Sunita Reddy	17/04/2025

Annexure-5: Site Closure Communication to IEC/Sponsor

Date	Recipient	Summary Contents	Submitted By
18/04/2025	IEC Chairperson	Final subject data, AE summary, ISF status	Rajesh Kumar

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial Release	Regulatory Compliance	QA Head
17/04/2025	2.0	Included templates for formal IEC closure communication	Audit Observation	QA Head