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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

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Standard Operating Procedure for Expanded Access and Compassionate Use Submissions in Clinical Trials

Purpose

The purpose of this SOP is to establish a standardized process for the preparation, submission, and follow-up of Expanded Access and Compassionate Use applications for investigational products. These submissions ensure that patients with serious or life-threatening conditions, who lack therapeutic alternatives, can access investigational drugs outside traditional clinical trials, in compliance with ICH-GCP, WHO, FDA, EMA, CDSCO, and other global regulatory authority requirements.

Scope

This SOP applies to sponsors, investigators, regulatory affairs personnel, and clinical research teams involved in Expanded Access/Compassionate Use submissions. It includes dossier preparation, submission to regulatory authorities and ethics committees, monitoring of patient safety, and documentation requirements.

Responsibilities

• Principal Investigator (PI): Identifies eligible patients and initiates requests for compassionate use.
• Regulatory Affairs Manager: Prepares and submits applications to regulatory agencies and ethics committees.
• Pharmacovigilance Officer: Monitors patient safety and reports adverse events.
• Quality Assurance Officer: Ensures compliance of submissions with applicable regulations.
• Head of Clinical Research: Reviews and approves applications before submission.

Accountability

The Head of Regulatory Affairs is accountable for ensuring compliance with all regulatory requirements for compassionate use submissions. Failure to comply may result in rejection of applications or regulatory sanctions.

Procedure

1. Patient Eligibility Assessment
PI evaluates patient condition to determine eligibility for compassionate use.
Patient must have a serious or life-threatening condition with no satisfactory alternatives.
Obtain informed consent from the patient or legal guardian.

2. Preparation of Submission Dossier
Prepare a comprehensive dossier including patient history, treatment rationale, Investigator’s Brochure, and product safety data.
Include compassionate use protocol, informed consent form, and risk mitigation strategies.
Compile cover letter, application forms, and regulatory checklists.

3. Ethics Committee/IRB Submission
Submit dossier to Ethics Committee (EC) or Institutional Review Board (IRB) for review and approval.
Ensure minutes of approval are documented and archived.

4. Regulatory Authority Submission
Submit application to national regulatory authority (e.g., FDA Expanded Access IND, EMA Compassionate Use Program, CDSCO expanded access submission).
Obtain written authorization prior to product dispensing.

5. Product Supply and Dispensing
Investigational product must be dispensed under controlled conditions.
Maintain product accountability logs and reconcile supply.

6. Safety Monitoring and Reporting
Monitor patients closely for adverse events.
Report SAEs and SUSARs to regulatory authorities within defined timelines.
Document safety follow-up in communication logs.

7. Documentation and Archiving
Maintain all compassionate use documentation in the Trial Master File (TMF).
Retain records for minimum of 5 years post completion.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• EC: Ethics Committee
• IRB: Institutional Review Board
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• TMF: Trial Master File
• IND: Investigational New Drug

Documents

1. Compassionate Use Application Form (Annexure-1)
2. Patient Eligibility and Consent Form (Annexure-2)
3. Compassionate Use Communication Log (Annexure-3)

References

• ICH E6(R2) Good Clinical Practice
• US FDA Expanded Access IND Guidance
• EMA Compassionate Use Program Guidelines
• WHO Good Clinical Practices
• CDSCO Clinical Trial Rules, 2019

Version: 1.0

Approval Section

Annexures

Annexure-1: Compassionate Use Application Form

Annexure-2: Patient Eligibility and Consent Form

Annexure-3: Compassionate Use Communication Log

Revision History

For more SOPs visit: Pharma SOP