as part of IND-regulated clinical trials conducted in the United States. It ensures compliance with 21 CFR 312.53 and related regulatory requirements, and facilitates FDA inspections.

Scope

This SOP applies to sponsors, investigators, regulatory affairs, CROs, and QA personnel involved in FDA IND clinical trials. It covers initial Form 1572 collection, updates for investigator/site changes, maintenance of records, and inspection readiness.

Responsibilities

• Sponsor: Collects and maintains Form 1572s for all investigators and submits them to FDA when required.
• Investigator: Completes and signs Form 1572 truthfully, commits to protocol and regulatory requirements.
• Regulatory Affairs: Ensures timely collection and submission of updates to FDA.
• CRO: Supports collection, verification, and filing of Form 1572s in TMF/ISF.
• QA: Audits Form 1572 compliance and readiness for FDA inspection.

Accountability

The Sponsor’s Regulatory Affairs Head is accountable for oversight of FDA Form 1572 compliance. Investigators are accountable for accurate and truthful completion of the form.

Procedure

1. Initial Collection
1.1 Collect completed Form 1572 from each investigator before subject enrollment.
1.2 Verify accuracy against investigator CV and clinical site details.
1.3 Record in Form 1572 Collection Log (Annexure-1).

2. Updates and Amendments
2.1 Require updated Form 1572 for any change in investigators, sub-investigators, or facilities.
2.2 Submit updates to FDA as part of IND amendments.
2.3 Record updates in Form 1572 Amendment Log (Annexure-2).

3. Maintenance of Records
3.1 File signed forms in both TMF and ISF.
3.2 Retain for minimum of 2 years after IND discontinuation.
3.3 Record in Form 1572 Maintenance Log (Annexure-3).

4. Verification
4.1 Cross-check investigator qualifications and facilities.
4.2 Ensure financial disclosure and CV are aligned with Form 1572.
4.3 Document verification in Form 1572 Verification Log (Annexure-4).

5. Inspection Readiness
5.1 Maintain forms in inspection-ready condition.
5.2 Record inspection preparations in Form 1572 Readiness Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• FDA: Food and Drug Administration
• IND: Investigational New Drug
• QA: Quality Assurance
• CRO: Contract Research Organization
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. Form 1572 Collection Log (Annexure-1)
2. Form 1572 Amendment Log (Annexure-2)
3. Form 1572 Maintenance Log (Annexure-3)
4. Form 1572 Verification Log (Annexure-4)
5. Form 1572 Readiness Log (Annexure-5)

References

• FDA – Form 1572 Statement of Investigator
• 21 CFR Part 312 – IND Regulations
• ICH GCP E6(R2)

Version: 1.0

Approval Section

Prepared By	Ravi Kumar, Regulatory Affairs Specialist
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Head Clinical Operations

Annexures

Annexure-1: Form 1572 Collection Log

Date	Investigator Name	Site	Collected By	Status
01/09/2025	Dr. Rajesh Kumar	NY Clinical Center	Reg Affairs	Filed

Annexure-2: Form 1572 Amendment Log

Date	Investigator	Amendment	Submitted To FDA	Status
02/09/2025	Dr. Rajesh Kumar	Added Sub-Investigator	Yes	Completed

Annexure-3: Form 1572 Maintenance Log

Date	Form Version	Stored In	Reviewed By
03/09/2025	v1.0	TMF/ISF	QA Officer

Annexure-4: Form 1572 Verification Log

Date	Investigator	Verification Performed	Reviewed By	Status
04/09/2025	Dr. Rajesh Kumar	CV/Disclosure Checked	Reg Affairs	Compliant

Annexure-5: Form 1572 Readiness Log

Date	Activity	Performed By	Status
05/09/2025	Inspection Simulation	QA Team	Completed

Revision History

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

For more SOPs visit: Pharma SOP