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

1. Initiate risk identification during project kick-off.
2. 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

1. Rate each risk on:
   • Probability: Low (1), Medium (2), High (3)
   • Impact: Low (1), Medium (2), High (3)
2. Calculate Risk Score = Probability × Impact
3. Document in Annexure-2: Risk Assessment Matrix

5.3 Risk Mitigation and Contingency Planning

1. Develop mitigation plans for all risks with score ≥ 4.
2. Each mitigation plan should define:
   • Responsible person
   • Timeline
   • Resources required
3. Capture mitigation steps in Annexure-3: Risk Mitigation Plan

5.4 Risk Monitoring

1. Review the Risk Register bi-weekly during study meetings.
2. Update risk status (Open/Controlled/Closed) in Annexure-4: Risk Tracking Log

5.5 Lessons Learned

1. Post-study, conduct a risk review workshop.
2. 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

1. Risk Identification Template – Annexure-1
2. Risk Assessment Matrix – Annexure-2
3. Risk Mitigation Plan – Annexure-3
4. Risk Tracking Log – Annexure-4
5. 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