SOP for Delegation of Responsibilities and Duty Log

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Published on 21/12/2025

Standard Operating Procedure for Delegation of Responsibilities and Duty Log

Department	Clinical Research
SOP No.	CR/INV/020/2025
Supersedes	NA
Page No.	1 of 23
Issue Date	26/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

Table of Contents

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

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

References

Version: 1.0

Approval Section

Prepared By	Rajesh Kumar, Clinical Research Coordinator
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Principal Investigator

Annexures

Annexure-1: Delegation of Authority Log

Staff Name	Role	Task Delegated	Qualifications	Start Date	PI Signature
Dr. Meera Joshi	Sub-Investigator	Adverse Event Documentation	MD, 10 yrs clinical experience	10/09/2025	Signed

Annexure-2: Duty Log Maintenance Checklist

Date	Checked By	Remarks
15/09/2025	Sunita Reddy	Delegation log updated correctly

Annexure-3: Staff Qualification Record

Staff Name	Qualification	Experience	Verification Status
Rajesh Kumar	MSc Clinical Research	5 years	Verified

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head, Clinical Research

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