SOP for Emergency IND (eIND) Requests and Management

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Published on 26/12/2025

Standard Operating Procedure for Emergency IND (eIND) Requests and Management

SOP No.	CR/OPS/130/2025
Supersedes	NA
Page No.	1 of 67
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 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

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

References

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: Emergency IND Log

Date	Subject ID	Condition	Investigator	Status
01/09/2025	E101	Life-threatening infection	PI	Initiated

Annexure-2: FDA Communication Log

Date	Contacted FDA Official	Mode	Authorization Granted	Recorded By
01/09/2025	Dr. John Smith	Phone	Yes	PI

Annexure-3: Written Submission Log

Date	Protocol ID	Submitted To FDA	Submitted By	Status
02/09/2025	EIND-01	Yes	Reg Affairs	Filed

Annexure-4: eIND Consent Log

Date	Subject ID	Consent Obtained	Investigator	Status
01/09/2025	E101	Yes	PI	Signed

Annexure-5: IRB Notification Log

Date	Subject ID	Notified IRB	Submitted By	Status
03/09/2025	E101	Yes	Reg Affairs	Completed

Annexure-6: Drug Administration Log

Date	Subject ID	Dose	Route	Administered By
01/09/2025	E101	200 mg	IV	Investigator

Annexure-7: eIND Follow-Up Log

Date	Subject ID	Report Type	Submitted To	Status
05/09/2025	E101	Safety Report	FDA/IRB	Submitted

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

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