Standard Operating Procedure for Project Risk Identification and Mitigation in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/043/2025 |
| Supersedes | SOP/BA-BE/043/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a structured approach for the identification, assessment, documentation, and mitigation of project risks in Bioavailability/Bioequivalence (BA/BE) studies, ensuring study continuity, data integrity, and regulatory compliance.
2. Scope
This SOP applies to all BA/BE studies conducted or sponsored by the organization, covering operational, regulatory, clinical, vendor, and timeline-related risks throughout the study lifecycle.
3. Responsibilities
- Clinical Project Manager (CPM): Leads the risk management process and maintains the Risk Register.
- Functional Department Heads: Identify functional risks and propose mitigation strategies.
- Quality Assurance (QA): Reviews the risk plan for regulatory alignment and audit preparedness.
- Regulatory Affairs: Assesses potential compliance risks.
4. Accountability
The Head of Clinical Operations is accountable for ensuring that risk management is integrated into the project management framework and reviewed periodically for adequacy and responsiveness.
5. Procedure
5.1 Risk Identification
- Initiate risk identification during project kick-off.
- Use Annexure-1: Risk Identification Template to document all foreseeable risks under the following categories:
- Study Start-up (e.g., EC delays, site readiness)
- Clinical Operations (e.g., volunteer dropout, protocol deviations)
- Data Management (e.g., CRF entry backlogs)
- Bioanalysis (e.g., sample loss, contamination)
- Regulatory (e.g., import license delays, audit findings)
5.2 Risk Assessment
- Rate each risk on:
- Probability: Low (1), Medium (2), High (3)
- Impact: Low (1), Medium (2), High (3)
- Calculate Risk Score = Probability × Impact
- Document in Annexure-2: Risk Assessment Matrix
5.3 Risk Mitigation and Contingency Planning
- Develop mitigation plans for all risks with score ≥ 4.
- Each mitigation plan should define:
- Responsible person
- Timeline
- Resources required
- Capture mitigation steps in Annexure-3: Risk Mitigation Plan
5.4 Risk Monitoring
- Review the Risk Register bi-weekly during study meetings.
- Update risk status (Open/Controlled/Closed) in Annexure-4: Risk Tracking Log
5.5 Lessons Learned
- Post-study, conduct a risk review workshop.
- Document key lessons in Annexure-5: Risk Closure and Learning Sheet
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CPM: Clinical Project Manager
- EC: Ethics Committee
- CRF: Case Report Form
7. Documents
- Risk Identification Template – Annexure-1
- Risk Assessment Matrix – Annexure-2
- Risk Mitigation Plan – Annexure-3
- Risk Tracking Log – Annexure-4
- Risk Closure and Learning Sheet – Annexure-5
8. References
- ICH Q9 – Quality Risk Management
- ICH E6(R2) – Good Clinical Practice
- CDSCO Guidance on Risk-based Study Oversight
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Risk Identification Template
| Risk ID | Category | Description | Identified By | Date |
|---|---|---|---|---|
| RISK-01 | Clinical | Volunteer dropouts may exceed 20% | Rajesh Kumar | 12/04/2025 |
Annexure-2: Risk Assessment Matrix
| Risk ID | Probability | Impact | Score | Severity |
|---|---|---|---|---|
| RISK-01 | 3 | 3 | 9 | High |
Annexure-3: Risk Mitigation Plan
| Risk ID | Mitigation Strategy | Owner | Due Date | Status |
|---|---|---|---|---|
| RISK-01 | Maintain 25% over-enrollment buffer | Sunita Reddy | 18/04/2025 | In Progress |
Annexure-4: Risk Tracking Log
| Risk ID | Status | Last Reviewed | Reviewed By |
|---|---|---|---|
| RISK-01 | Controlled | 16/04/2025 | Dr. Arvind Shah |
Annexure-5: Risk Closure and Learning Sheet
| Risk ID | Outcome | Lesson Learned | Recommendations |
|---|---|---|---|
| RISK-01 | Dropouts remained below 10% | Buffer planning effective | Standardize 25% buffer in similar studies |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 15/01/2022 | 1.0 | Initial SOP | New implementation | QA Head |
| 17/04/2025 | 2.0 | Added annexures and monitoring cycle | ICH Q9 compliance | QA Head |