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Standard Operating Procedure for Delegation of Responsibilities and Duty Log

Purpose

The purpose of this SOP is to establish procedures for the delegation of responsibilities by the Principal Investigator (PI) and the maintenance of a duty log to ensure accountability in clinical trial conduct. This process provides transparency in task allocation and compliance with international regulatory requirements.

Scope

This SOP applies to Principal Investigators, sub-investigators, clinical research coordinators, study staff, sponsors, and CROs responsible for assigning and documenting responsibilities during clinical trials. It is relevant for both site-level and sponsor-level delegation tracking.

Responsibilities

• Principal Investigator (PI): Delegates responsibilities appropriately and signs/approves delegation logs.
• Sub-Investigators: Perform delegated tasks within their qualifications and document performance.
• Study Coordinator: Maintains updated duty logs and ensures records are accessible.
• Sponsor/CRO: Reviews delegation logs during monitoring visits.
• Quality Assurance Officer: Verifies delegation logs during audits for compliance.

Accountability

The Principal Investigator is ultimately accountable for all trial-related tasks, even when delegated. The duty log provides evidence of compliance and ensures that only qualified individuals perform specific activities.

Procedure

1. Delegation Planning
Prior to trial initiation, PI identifies trial-related tasks that can be delegated.
Ensure delegated staff are qualified by training and experience.

2. Completion of Delegation Log
Record all delegated responsibilities in the Delegation of Authority Log (Annexure-1).
Each entry must include staff name, role, task delegated, qualifications, start date, and PI signature.

3. Updates and Amendments
Update delegation logs when new staff join, tasks change, or staff leave.
Maintain version control of delegation logs.

4. Monitoring and Review
Sponsors and monitors must verify delegation logs during site visits.
PI must review duty log periodically to ensure accuracy.

5. Documentation and Filing
Store delegation logs in the Investigator Site File (ISF) and Trial Master File (TMF).
Provide access to regulators and auditors upon request.

6. Archiving
Archive delegation logs for at least 5 years after trial completion or longer as per local regulations.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRO: Clinical Research Organization
• ISF: Investigator Site File
• TMF: Trial Master File
• QA: Quality Assurance

Documents

1. Delegation of Authority Log (Annexure-1)
2. Duty Log Maintenance Checklist (Annexure-2)
3. Staff Qualification Record (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA Guidance on Investigator Responsibilities
• EMA Clinical Trial Regulation (EU No. 536/2014)
• CDSCO Clinical Trial Rules, 2019
• WHO Guidance on Clinical Research Ethics

Version: 1.0

Approval Section

Annexures

Annexure-1: Delegation of Authority Log

Annexure-2: Duty Log Maintenance Checklist

Annexure-3: Staff Qualification Record

Revision History

For more SOPs visit: Pharma SOP