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“headline”: “SOP for Emergency IND (eIND) Requests and Management”,
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Standard Operating Procedure for Emergency IND (eIND) Requests and Management

Purpose

The purpose of this SOP is to provide standardized procedures for requesting and managing Emergency IND (eIND) submissions to the U.S. Food and Drug Administration (FDA) under 21 CFR 312.310. It ensures that investigational products can be used in urgent, life-threatening situations where no satisfactory alternatives exist, while maintaining compliance with regulatory and ethical standards.

Scope

This SOP applies to investigators, sponsors, CROs, regulatory affairs, and clinical staff involved in eIND requests and emergency investigational product administration in the United States. It covers verbal requests, written submissions, IRB notifications, consent procedures, documentation, and regulatory inspection readiness.

Responsibilities

• Investigator: Identifies emergency use, contacts FDA, obtains consent, and ensures follow-up reporting.
• Sponsor: Oversees compliance with eIND regulations, ensures documentation, and communicates with FDA.
• Regulatory Affairs: Coordinates eIND submissions, prepares written follow-up, and ensures archival.
• CRO: Supports communication and tracking of eIND requests.
• IRB/EC: Receives notification of eIND use and ensures ethical oversight.
• QA: Audits eIND procedures and ensures inspection readiness.

Accountability

The Principal Investigator is accountable for the accurate execution of emergency IND procedures, including patient safety and regulatory compliance. The Sponsor’s Regulatory Head is accountable for FDA communication and timely submissions.

Procedure

1. Identification of Emergency Use
1.1 Confirm that the subject has a life-threatening condition and no standard therapy is available.
1.2 Document in Emergency IND Log (Annexure-1).

2. Initial FDA Request
2.1 Contact FDA by phone for verbal authorization.
2.2 Record call details in FDA Communication Log (Annexure-2).

3. Written Submission
3.1 Submit written eIND request to FDA within 15 working days.
3.2 Include protocol, investigator information, and rationale.
3.3 Maintain Written Submission Log (Annexure-3).

4. Informed Consent
4.1 Obtain subject or legally authorized representative’s informed consent prior to administration.
4.2 Record in eIND Consent Log (Annexure-4).

5. IRB Notification
5.1 Notify IRB within 5 working days of emergency use.
5.2 Document in IRB Notification Log (Annexure-5).

6. Drug Administration
6.1 Administer investigational product under FDA verbal authorization.
6.2 Document dose and administration details in Drug Administration Log (Annexure-6).

7. Follow-Up and Reporting
7.1 Submit follow-up safety reports to FDA and IRB.
7.2 Maintain in eIND Follow-Up Log (Annexure-7).

8. Archiving
8.1 Archive eIND records in TMF and ISF.
8.2 Retain records as per regulatory requirements.

Abbreviations

• SOP: Standard Operating Procedure
• eIND: Emergency Investigational New Drug
• FDA: Food and Drug Administration
• IRB/EC: Institutional Review Board/Ethics Committee
• QA: Quality Assurance
• CRO: Contract Research Organization
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. Emergency IND Log (Annexure-1)
2. FDA Communication Log (Annexure-2)
3. Written Submission Log (Annexure-3)
4. eIND Consent Log (Annexure-4)
5. IRB Notification Log (Annexure-5)
6. Drug Administration Log (Annexure-6)
7. eIND Follow-Up Log (Annexure-7)

References

• 21 CFR Part 312 – Investigational New Drug Application
• FDA – Emergency Use of Investigational Drugs
• ICH GCP – Ethical and Safety Considerations

Version: 1.0

Approval Section

Annexures

Annexure-1: Emergency IND Log

Annexure-2: FDA Communication Log

Annexure-3: Written Submission Log

Annexure-4: eIND Consent Log

Annexure-5: IRB Notification Log

Annexure-6: Drug Administration Log

Annexure-7: eIND Follow-Up Log

Revision History

For more SOPs visit: Pharma SOP