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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

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Standard Operating Procedure for Protocol Amendments and Regulatory Notifications in Clinical Trials

Purpose

The purpose of this SOP is to describe the process for preparing, reviewing, submitting, and tracking clinical trial protocol amendments and associated regulatory notifications. This ensures compliance with ICH GCP, GMP, WHO guidelines, and national regulatory authority requirements (FDA, EMA, MHRA, CDSCO, TGA).

Scope

This SOP applies to all clinical research staff, investigators, regulatory affairs personnel, and quality assurance teams involved in protocol amendments and regulatory notifications for ongoing or planned clinical trials. It covers both substantial amendments (those impacting patient safety, trial conduct, or data integrity) and non-substantial amendments.

Responsibilities

• Principal Investigator (PI): Initiates protocol amendment requests and ensures scientific justification.
• Regulatory Affairs Manager: Prepares and submits amendment packages to regulatory authorities and ethics committees.
• Clinical Research Associate (CRA): Communicates changes to site staff and ensures implementation.
• Quality Assurance Officer: Verifies compliance of amendments with regulatory requirements.
• Head of Clinical Research: Approves protocol changes prior to submission.

Accountability

The Regulatory Affairs Head is accountable for ensuring all amendments and notifications are submitted accurately and within the defined timelines. Failure to notify may result in regulatory non-compliance, trial suspension, or penalties.

Procedure

1. Identification of Amendment Requirement
Determine if proposed changes qualify as substantial (e.g., changes to trial endpoints, dosage, inclusion/exclusion criteria) or non-substantial (e.g., administrative corrections).
Document rationale for amendment in an Amendment Request Form.

2. Preparation of Amendment Dossier
Update the Clinical Trial Protocol with tracked changes.
Revise associated documents (e.g., Informed Consent Form, Investigator’s Brochure).
Compile country-specific forms and cover letters.
Ensure updated safety information is included, if applicable.

3. Internal Review and Approval
Submit amendment dossier to QA for compliance review.
Obtain internal approvals from the Head of Clinical Research.
Maintain version control and document history.

4. Submission to Regulatory Authority and Ethics Committee
Submit amendment electronically via eCTD or as required by local authority.
Notify the Ethics Committee/IRB with complete amendment dossier.
Ensure acknowledgment of submission is filed in the Regulatory Communication Log.

5. Notification to Sites and Investigators
Provide site staff with revised protocol and training, if applicable.
Ensure investigators sign acknowledgment of receipt of updated documents.

6. Documentation and Archiving
File all amendment-related documents in the Trial Master File (TMF).
Maintain amendment tracking log for audit readiness.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRA: Clinical Research Associate
• QA: Quality Assurance
• eCTD: Electronic Common Technical Document
• TMF: Trial Master File
• EC/IRB: Ethics Committee/Institutional Review Board

Documents

1. Amendment Request Form (Annexure-1)
2. Amendment Tracking Log (Annexure-2)
3. Regulatory Communication Log (Annexure-3)

References

• ICH E6(R2) Good Clinical Practice
• US FDA Guidance on Protocol Amendments
• EMA Clinical Trial Regulation (EU No. 536/2014)
• WHO Good Clinical Practice Guidelines
• CDSCO Clinical Trial Rules, India (2019)

Version: 1.0

Approval Section

Annexures

Annexure-1: Amendment Request Form

Annexure-2: Amendment Tracking Log

Annexure-3: Regulatory Communication Log

Revision History

For more SOPs visit: Pharma SOP