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Standard Operating Procedure for Right-to-Try/Expanded Access Coordination (When Applicable)

Purpose

The purpose of this SOP is to define standardized procedures for coordinating Right-to-Try and Expanded Access (Compassionate Use) programs for investigational products in the United States. It ensures that patients with serious or life-threatening conditions who lack satisfactory alternatives can gain access to investigational therapies in compliance with FDA regulations and ethical standards.

Scope

This SOP applies to sponsors, investigators, CROs, regulatory affairs, and QA personnel involved in Right-to-Try or Expanded Access requests. It covers patient eligibility determination, informed consent, IRB notification, FDA submissions (for Expanded Access), sponsor and investigator responsibilities, and documentation for inspection readiness.

Responsibilities

• Sponsor: Reviews and approves expanded access requests, ensures compliance with FDA and Right-to-Try requirements, and provides investigational product.
• Investigator: Confirms patient eligibility, obtains informed consent, notifies IRB, and administers investigational product.
• Regulatory Affairs: Prepares submissions to FDA for Expanded Access programs and maintains records.
• CRO: Supports documentation, monitoring, and reporting for expanded access cases.
• QA: Audits processes and ensures compliance with inspection readiness requirements.

Accountability

The Sponsor’s Regulatory Head is accountable for overseeing all Right-to-Try and Expanded Access requests. Investigators are accountable for patient safety, ethical compliance, and site-level documentation.

Procedure

1. Patient Eligibility
1.1 Confirm patient has a serious or life-threatening condition with no satisfactory alternatives.
1.2 Ensure patient is not eligible for ongoing clinical trials.
1.3 Document in Expanded Access Eligibility Log (Annexure-1).

2. Right-to-Try Pathway
2.1 Confirm investigational product has completed Phase I trials and is not FDA-approved.
2.2 Obtain informed consent from patient or legally authorized representative.
2.3 Record in Right-to-Try Consent Log (Annexure-2).

3. Expanded Access Pathway (FDA Regulated)
3.1 Investigator submits Expanded Access IND or protocol amendment to FDA under 21 CFR 312.305.
3.2 Notify IRB within 5 working days.
3.3 Document in FDA Submission Log (Annexure-3).

4. Product Administration
4.1 Administer investigational product per FDA or Right-to-Try authorization.
4.2 Monitor patient closely for adverse events.
4.3 Document administration in Product Administration Log (Annexure-4).

5. Adverse Event Reporting
5.1 Report serious adverse events to sponsor and FDA (for Expanded Access).
5.2 Record in Adverse Event Log (Annexure-5).

6. Follow-Up and Long-Term Monitoring
6.1 Collect follow-up data on patient outcomes.
6.2 Maintain in Follow-Up Monitoring Log (Annexure-6).

7. Archiving
7.1 Archive all expanded access and Right-to-Try records in TMF and ISF.
7.2 Retain records as per regulatory timelines.

Abbreviations

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

Documents

1. Expanded Access Eligibility Log (Annexure-1)
2. Right-to-Try Consent Log (Annexure-2)
3. FDA Submission Log (Annexure-3)
4. Product Administration Log (Annexure-4)
5. Adverse Event Log (Annexure-5)
6. Follow-Up Monitoring Log (Annexure-6)

References

• FDA – Expanded Access Program
• Right-to-Try Act of 2017
• 21 CFR 312.305 – Requirements for Expanded Access
• ICH GCP Ethical Principles

Version: 1.0

Approval Section

Annexures

Annexure-1: Expanded Access Eligibility Log

Annexure-2: Right-to-Try Consent Log

Annexure-3: FDA Submission Log

Annexure-4: Product Administration Log

Annexure-5: Adverse Event Log

Annexure-6: Follow-Up Monitoring Log

Revision History

For more SOPs visit: Pharma SOP