Standard Operating Procedure for Creating Clinical Site Close-Out Checklist in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/128/2025 |
| Supersedes | SOP/BA-BE/128/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for preparing and executing a standardized Clinical Site Close-Out Checklist for bioavailability/bioequivalence (BA/BE) studies, ensuring all site activities are properly concluded and documented.
2. Scope
This SOP applies to study monitors, clinical research associates (CRAs), and project managers involved in the site close-out process for BA/BE clinical trials.
3. Responsibilities
- CRA/Monitor: Prepares and executes 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
- Initiate close-out checklist once the last subject’s last visit (LSLV) and data collection are complete.
- Notify site via formal communication using Annexure-1: Site Close-Out Notification Template.
5.2 Close-Out Checklist Preparation
- Download and customize Annexure-2: Site Close-Out Checklist.
- 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
- Conduct the visit in the presence of the PI and study coordinator.
- 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
- Document observations and pending actions in Annexure-3: Site Close-Out Visit Report.
5.4 Final Sign-Off and Archival
- Review completed checklist and ensure no open action items remain.
- PI and CRA must sign off Annexure-4: Site Close-Out Certification Form.
- Archive all original documents at the site and send copies to sponsor/CRO.
5.5 Communication to Sponsor and Ethics Committee
- Send formal notification of site closure to the sponsor and Institutional Ethics Committee (IEC) using Annexure-5.
- 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
- Site Close-Out Notification Template – Annexure-1
- Site Close-Out Checklist – Annexure-2
- Site Close-Out Visit Report – Annexure-3
- Site Close-Out Certification Form – Annexure-4
- 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 |