SOP for Investigator Qualification and CV Management

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Published on 23/12/2025

Standard Operating Procedure for Investigator Qualification and CV Management

Department	Clinical Research
SOP No.	CR/INV/018/2025
Supersedes	NA
Page No.	1 of 22
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 a standardized process for assessing investigator qualifications and managing curriculum vitae (CVs) to ensure only qualified

investigators conduct clinical trials. It ensures compliance with ethical principles, Good Clinical Practice (GCP), and global regulatory requirements.

Scope

This SOP applies to all investigators, sub-investigators, sponsors, clinical research organizations (CROs), and study teams involved in maintaining investigator qualifications and CVs across clinical trial sites globally.

Responsibilities

Principal Investigator (PI): Ensures submission of updated CVs and proof of qualifications before trial initiation.
Sub-Investigators: Provide CVs and maintain current records of training and experience.
Sponsor/Clinical Research Organization (CRO): Verifies investigator credentials and maintains copies in the Trial Master File (TMF).
Clinical Research Coordinator: Ensures investigator CVs are collected, signed, and dated.
Quality Assurance Officer: Reviews investigator qualification files during audits.

Accountability

The sponsor and PI are accountable for ensuring that all investigators are qualified by education, training, and experience. CVs and supporting documentation must be complete, accurate, signed, and dated to withstand audits and inspections.

Procedure

1. Collection of CVs
Obtain signed and dated CVs from all investigators and sub-investigators prior to trial initiation.
CVs must be updated within the last 2 years or as required by regulatory guidelines.

2. Verification of Credentials
Verify medical licenses, academic degrees, and professional certifications.
Cross-check registration with national medical councils where applicable.

3. Maintenance of Investigator Files
Store copies of CVs in both Site Investigator File (SIF) and Trial Master File (TMF).
Ensure electronic copies are stored in secured systems with restricted access.

4. Updating and Tracking
Investigators must submit updated CVs every 2 years or whenever new qualifications are obtained.
Maintain a CV Tracking Log at site and sponsor level.

5. Review by Ethics Committee/IRB
Submit investigator CVs to EC/IRB during initial approval and when major updates occur.

6. Archiving
Archive investigator CVs for at least 5 years after trial completion, or longer if required by national law.

Abbreviations

SOP: Standard Operating Procedure
PI: Principal Investigator
CRO: Clinical Research Organization
CV: Curriculum Vitae
EC: Ethics Committee
IRB: Institutional Review Board
TMF: Trial Master File
SIF: Site Investigator File

Documents

Investigator CV Template (Annexure-1)
CV Tracking Log (Annexure-2)
Credential Verification Checklist (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: Investigator CV Template

Section	Details
Name	[Investigator Name]
Qualifications	[Degrees, Certifications]
Experience	[Clinical and Research Experience]
Signature & Date	[Signed & Dated by Investigator]

Annexure-2: CV Tracking Log

Date	Investigator Name	CV Version	Received By	Remarks
12/09/2025	Dr. Meera Joshi	V3.0	Rajesh Kumar	Accepted

Annexure-3: Credential Verification Checklist

Investigator	Medical License Verified	Academic Degree Verified	Professional Certification	Completed By
Dr. Meera Joshi	Yes	Yes	Yes	QA Officer

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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