Standard Operating Procedure for Clinical Site Monitoring Visits in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/087/2025 |
| Supersedes | SOP/BA-BE/087/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a systematic process for planning, conducting, and documenting clinical site monitoring visits during Bioavailability/Bioequivalence (BA/BE) studies, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory compliance.
2. Scope
This SOP is applicable to clinical monitors, sponsor representatives, CROs, and study site staff involved in the conduct of monitoring visits at BA/BE study sites, including pre-study, initiation, interim, and close-out visits.
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
- Pre-Study Visit (PSV): To assess the facility’s qualifications and readiness.
- Study Initiation Visit (SIV): To train staff, confirm regulatory documents, and assess readiness.
- Interim Monitoring Visit (IMV): To verify source data, IMP accountability, and protocol compliance.
- Close-Out Visit (COV): To ensure all documents are complete, IMP is returned/destroyed, and study is closed properly.
5.2 Planning and Communication
- Schedule visits in coordination with site staff and document in Annexure-1: Visit Calendar.
- Prepare checklist of objectives using Annexure-2: Monitoring Visit Checklist.
- Send confirmation email with agenda and required documents.
5.3 Conducting the Visit
- 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
- Discuss preliminary findings with site team at end of visit.
5.4 Documentation
- Prepare Annexure-3: Monitoring Visit Report within 5 working days of the visit.
- Log all findings and required actions in Annexure-4: Monitoring Findings Log.
- Send the final report to QA, sponsor, and PI.
5.5 Follow-up and Resolution
- Track resolution of all findings within defined timelines.
- 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
- Visit Calendar – Annexure-1
- Monitoring Visit Checklist – Annexure-2
- Monitoring Visit Report – Annexure-3
- Monitoring Findings Log – Annexure-4
- 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 |