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Standard Operating Procedure for Investigator Financial Disclosure Management

Purpose

The purpose of this SOP is to outline the procedures for collecting, reviewing, and managing investigator financial disclosures in clinical trials. These disclosures identify any financial interests that could potentially bias clinical trial outcomes, ensuring compliance with international and national regulations.

Scope

This SOP applies to all investigators, sub-investigators, sponsors, and CROs involved in clinical trials requiring disclosure of financial relationships, including equity holdings, consultancy payments, honoraria, or other financial interests that could influence study conduct or results.

Responsibilities

• Principal Investigator (PI): Completes financial disclosure forms accurately and submits updates when changes occur.
• Sub-Investigators: Provide financial disclosure information prior to trial participation.
• Sponsor/Regulatory Affairs: Reviews disclosures for conflicts of interest and ensures reporting to regulatory authorities.
• Clinical Research Coordinator: Collects and files completed disclosure forms in site and sponsor files.
• Quality Assurance Officer: Audits financial disclosure documentation for compliance.

Accountability

The sponsor and Principal Investigator are accountable for ensuring accurate financial disclosures are maintained and reported in accordance with regulatory requirements. Undisclosed conflicts of interest may result in invalidation of trial results or regulatory penalties.

Procedure

1. Collection of Financial Disclosures
Require investigators and sub-investigators to complete financial disclosure forms prior to study initiation.
Use standardized templates (Annexure-1).

2. Disclosure Categories
Equity interests in the sponsor company.
Proprietary interests in the investigational product.
Significant payments of other sorts (SPOOS).
Consultancy, honoraria, or royalties related to the sponsor.

3. Review of Disclosures
Sponsor reviews submitted disclosures for potential conflicts.
Conflicts are assessed by regulatory/legal teams and corrective action plans documented.

4. Updates and Ongoing Disclosures
Investigators must update disclosures annually or within 30 days of any change.
Study coordinator tracks updates in Disclosure Tracking Log (Annexure-2).

5. Regulatory Reporting
Report investigator financial disclosures to regulatory authorities during IND/CTA submissions, NDA/MAA filings, or as required.
Submit summary reports in accordance with FDA, EMA, and CDSCO requirements.

6. Record Keeping
Maintain disclosure forms, review records, and regulatory submissions in TMF.
Archive documents for at least 5 years post-trial or as per local law.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRO: Clinical Research Organization
• EC: Ethics Committee
• IRB: Institutional Review Board
• TMF: Trial Master File
• SPOOS: Significant Payments of Other Sorts

Documents

1. Financial Disclosure Form (Annexure-1)
2. Disclosure Tracking Log (Annexure-2)
3. Conflict of Interest Review Record (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Financial Disclosure by Clinical Investigators
• EMA Clinical Trial Regulation
• CDSCO Clinical Trial Rules, 2019
• WHO – Clinical Research Ethics Guidance

Version: 1.0

Approval Section

Annexures

Annexure-1: Financial Disclosure Form

Annexure-2: Disclosure Tracking Log

Annexure-3: Conflict of Interest Review Record

Revision History

For more SOPs visit: Pharma SOP