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Standard Operating Procedure for FDA Form 1572 Collection, Updates, and Maintenance

Purpose

The purpose of this SOP is to describe the procedures for collecting, updating, and maintaining FDA Form 1572 (Statement of Investigator) as part of IND-regulated clinical trials conducted in the United States. It ensures compliance with 21 CFR 312.53 and related regulatory requirements, and facilitates FDA inspections.

Scope

This SOP applies to sponsors, investigators, regulatory affairs, CROs, and QA personnel involved in FDA IND clinical trials. It covers initial Form 1572 collection, updates for investigator/site changes, maintenance of records, and inspection readiness.

Responsibilities

• Sponsor: Collects and maintains Form 1572s for all investigators and submits them to FDA when required.
• Investigator: Completes and signs Form 1572 truthfully, commits to protocol and regulatory requirements.
• Regulatory Affairs: Ensures timely collection and submission of updates to FDA.
• CRO: Supports collection, verification, and filing of Form 1572s in TMF/ISF.
• QA: Audits Form 1572 compliance and readiness for FDA inspection.

Accountability

The Sponsor’s Regulatory Affairs Head is accountable for oversight of FDA Form 1572 compliance. Investigators are accountable for accurate and truthful completion of the form.

Procedure

1. Initial Collection
1.1 Collect completed Form 1572 from each investigator before subject enrollment.
1.2 Verify accuracy against investigator CV and clinical site details.
1.3 Record in Form 1572 Collection Log (Annexure-1).

2. Updates and Amendments
2.1 Require updated Form 1572 for any change in investigators, sub-investigators, or facilities.
2.2 Submit updates to FDA as part of IND amendments.
2.3 Record updates in Form 1572 Amendment Log (Annexure-2).

3. Maintenance of Records
3.1 File signed forms in both TMF and ISF.
3.2 Retain for minimum of 2 years after IND discontinuation.
3.3 Record in Form 1572 Maintenance Log (Annexure-3).

4. Verification
4.1 Cross-check investigator qualifications and facilities.
4.2 Ensure financial disclosure and CV are aligned with Form 1572.
4.3 Document verification in Form 1572 Verification Log (Annexure-4).

5. Inspection Readiness
5.1 Maintain forms in inspection-ready condition.
5.2 Record inspection preparations in Form 1572 Readiness Log (Annexure-5).

Abbreviations

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

Documents

1. Form 1572 Collection Log (Annexure-1)
2. Form 1572 Amendment Log (Annexure-2)
3. Form 1572 Maintenance Log (Annexure-3)
4. Form 1572 Verification Log (Annexure-4)
5. Form 1572 Readiness Log (Annexure-5)

References

• FDA – Form 1572 Statement of Investigator
• 21 CFR Part 312 – IND Regulations
• ICH GCP E6(R2)

Version: 1.0

Approval Section

Annexures

Annexure-1: Form 1572 Collection Log

Annexure-2: Form 1572 Amendment Log

Annexure-3: Form 1572 Maintenance Log

Annexure-4: Form 1572 Verification Log

Annexure-5: Form 1572 Readiness Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for FDAAA 801 Registration/Results Posting (PRS Compliance)”,
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Standard Operating Procedure for FDAAA 801 Registration/Results Posting (PRS Compliance)

Purpose

The purpose of this SOP is to establish procedures for registering clinical trials and posting results on ClinicalTrials.gov in compliance with the FDA Amendments Act (FDAAA) Section 801 and Protocol Registration and Results System (PRS). It ensures adherence to regulatory timelines and transparency obligations.

Scope

This SOP applies to sponsors, investigators, CROs, regulatory affairs teams, and data managers responsible for ClinicalTrials.gov submissions. It covers registration before trial initiation, updates during the trial, results posting upon completion, and handling of FDA inspections.

Responsibilities

• Sponsor: Ensures all applicable trials are registered and results are submitted within timelines.
• Investigator: Provides accurate study information and ensures data integrity.
• Regulatory Affairs: Prepares, reviews, and submits PRS entries to ClinicalTrials.gov.
• CRO: Supports PRS compliance activities and conducts quality reviews.
• QA: Audits PRS processes and ensures inspection readiness.

Accountability

The Sponsor’s Regulatory Affairs Lead is accountable for compliance with FDAAA 801 PRS requirements. Investigators are accountable for providing complete and accurate study data.

Procedure

1. Trial Registration
1.1 Register applicable clinical trials on ClinicalTrials.gov within 21 days of first subject enrollment.
1.2 Record in PRS Registration Log (Annexure-1).

2. Updates During the Trial
2.1 Update trial information within 30 days of protocol amendments or recruitment status changes.
2.2 Maintain updates in PRS Amendment Log (Annexure-2).

3. Results Posting
3.1 Submit summary results within 12 months of primary completion date.
3.2 Include baseline data, outcomes, adverse events, and protocol.
3.3 Record in PRS Results Posting Log (Annexure-3).

4. Quality Control
4.1 Perform internal QC checks before PRS submission.
4.2 Address ClinicalTrials.gov QC comments within 25 days.
4.3 Record in PRS QC Log (Annexure-4).

5. Compliance Monitoring
5.1 Maintain tracking of registration and results timelines.
5.2 Document compliance in PRS Compliance Log (Annexure-5).

6. Inspection Readiness
6.1 Ensure PRS records are inspection-ready.
6.2 Conduct mock inspections documented in PRS Inspection Readiness Log (Annexure-6).

Abbreviations

• SOP: Standard Operating Procedure
• PRS: Protocol Registration and Results System
• FDA: Food and Drug Administration
• FDAAA: Food and Drug Administration Amendments Act
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. PRS Registration Log (Annexure-1)
2. PRS Amendment Log (Annexure-2)
3. PRS Results Posting Log (Annexure-3)
4. PRS QC Log (Annexure-4)
5. PRS Compliance Log (Annexure-5)
6. PRS Inspection Readiness Log (Annexure-6)

References

• ClinicalTrials.gov PRS User Guide
• FDA – FDAAA 801 Requirements
• 42 CFR Part 11 – Clinical Trials Registration and Results Submission
• ICH GCP – Transparency and Disclosure Standards

Version: 1.0

Approval Section

Annexures

Annexure-1: PRS Registration Log

Annexure-2: PRS Amendment Log

Annexure-3: PRS Results Posting Log

Annexure-4: PRS QC Log

Annexure-5: PRS Compliance Log

Annexure-6: PRS Inspection Readiness Log

Revision History

For more SOPs visit: Pharma SOP

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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

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Standard Operating Procedure for IND Safety Reporting Specifics under 21 CFR 312.32 (US Timelines)

Purpose

The purpose of this SOP is to describe specific requirements for safety reporting under 21 CFR 312.32 for IND-regulated clinical trials in the United States. It ensures timely identification, evaluation, and reporting of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) to the FDA in compliance with regulatory timelines.

Scope

This SOP applies to sponsors, investigators, CROs, pharmacovigilance teams, and regulatory affairs personnel responsible for safety monitoring and reporting in U.S. IND trials. It covers expedited reporting, narrative submissions, follow-up reports, database management, and inspection readiness.

Responsibilities

• Sponsor: Ensures compliance with FDA reporting timelines, submits expedited reports, and maintains safety databases.
• Investigator: Reports all SAEs immediately to the sponsor, provides follow-up data, and documents assessments.
• CRO: Supports safety monitoring, reconciliation, and reporting activities.
• Pharmacovigilance Team: Manages safety database, performs case assessments, and prepares regulatory reports.
• Regulatory Affairs: Submits safety reports to FDA via electronic gateway.
• QA: Audits safety reporting workflows and inspection readiness.

Accountability

The Sponsor’s Drug Safety Officer is accountable for IND safety reporting compliance. Investigators remain accountable for subject-level SAE reporting.

Procedure

1. SAE Identification
1.1 Investigators must report SAEs to sponsor within 24 hours of awareness.
1.2 Record in SAE Log (Annexure-1).

2. Sponsor Evaluation
2.1 Assess causality, expectedness, and seriousness of each SAE.
2.2 Record assessment in SAE Assessment Log (Annexure-2).

3. Expedited Reporting to FDA
3.1 Report fatal or life-threatening SUSARs within 7 calendar days.
3.2 Report other SUSARs within 15 calendar days.
3.3 Submit reports via FDA electronic gateway (MedWatch Form 3500A).
3.4 Document in Expedited Reporting Log (Annexure-3).

4. Follow-Up Reports
4.1 Submit additional data or narratives as follow-up within 15 days.
4.2 Record in Follow-Up Reporting Log (Annexure-4).

5. Annual IND Reports
5.1 Submit annual safety report (DSUR/IND Annual Report) summarizing all SAEs.
5.2 Record in Annual Safety Report Log (Annexure-5).

6. Safety Database Management
6.1 Maintain validated safety database with audit trails.
6.2 Perform reconciliation with clinical databases quarterly.
6.3 Record in Database Reconciliation Log (Annexure-6).

7. Inspection Readiness
7.1 Maintain safety records in inspection-ready format.
7.2 Conduct mock inspections documented in Safety Inspection Log (Annexure-7).

Abbreviations

• SOP: Standard Operating Procedure
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• IND: Investigational New Drug
• DSUR: Development Safety Update Report
• CRO: Contract Research Organization
• QA: Quality Assurance
• FDA: Food and Drug Administration
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. SAE Log (Annexure-1)
2. SAE Assessment Log (Annexure-2)
3. Expedited Reporting Log (Annexure-3)
4. Follow-Up Reporting Log (Annexure-4)
5. Annual Safety Report Log (Annexure-5)
6. Database Reconciliation Log (Annexure-6)
7. Safety Inspection Log (Annexure-7)

References

• 21 CFR 312.32 – IND Safety Reporting
• FDA – IND Safety Reporting Guidance
• ICH GCP – E2A and E2F Safety Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: SAE Log

Annexure-2: SAE Assessment Log

Annexure-3: Expedited Reporting Log

Annexure-4: Follow-Up Reporting Log

Annexure-5: Annual Safety Report Log

Annexure-6: Database Reconciliation Log

Annexure-7: Safety Inspection Log

Revision History

For more SOPs visit: Pharma SOP

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Standard Operating Procedure for FDA Clinical Hold/Partial Hold Communications and Remediation

Purpose

The purpose of this SOP is to outline procedures for managing communications and remediation when the U.S. Food and Drug Administration (FDA) imposes a clinical hold or partial hold on an IND-regulated study under 21 CFR 312.42. It ensures timely resolution, protection of subject safety, and compliance with regulatory requirements.

Scope

This SOP applies to sponsors, investigators, CROs, regulatory affairs, and QA teams involved in clinical trials under IND oversight. It covers receipt of FDA hold notifications, communication with sites, subject safety measures, remediation planning, submissions to FDA, and trial resumption.

Responsibilities

• Sponsor: Coordinates responses to FDA, prepares remediation plans, and oversees CAPA implementation.
• Investigator: Ensures trial suspension at site level, safeguards subjects, and communicates with IRB.
• CRO: Assists in tracking corrective actions and monitors site compliance during hold.
• Regulatory Affairs: Manages FDA communications and formal submissions.
• QA: Audits remediation and ensures inspection readiness.
• IRB/EC: Reviews site-level implications and safety measures.

Accountability

The Sponsor’s Regulatory Head is accountable for ensuring compliance with FDA hold requirements. Investigators are accountable for site-level trial suspension and subject safety.

Procedure

1. Receipt of FDA Hold Notification
1.1 Document FDA hold letter upon receipt.
1.2 Record in Clinical Hold Log (Annexure-1).

2. Immediate Actions
2.1 Suspend subject enrollment immediately.
2.2 Notify investigators, CRO, and IRB.
2.3 Ensure subject safety monitoring continues.
2.4 Record in Site Notification Log (Annexure-2).

3. Root Cause Analysis and Remediation
3.1 Conduct investigation into issues cited by FDA.
3.2 Develop corrective and preventive action (CAPA) plan.
3.3 Document in Remediation Log (Annexure-3).

4. FDA Communication
4.1 Submit remediation plan to FDA within required timelines.
4.2 Maintain FDA Communication Log (Annexure-4).

5. Site and Subject Management
5.1 Inform subjects if their participation is affected.
5.2 Provide alternative medical care where needed.
5.3 Document in Subject Communication Log (Annexure-5).

6. Trial Resumption
6.1 Resume study activities only after FDA issues “Hold Lifted” notification.
6.2 Record in Trial Resumption Log (Annexure-6).

7. Archiving
7.1 Archive hold-related correspondence, CAPA documentation, and FDA responses in TMF and ISF.
7.2 Retain per regulatory timelines.

Abbreviations

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

Documents

1. Clinical Hold Log (Annexure-1)
2. Site Notification Log (Annexure-2)
3. Remediation Log (Annexure-3)
4. FDA Communication Log (Annexure-4)
5. Subject Communication Log (Annexure-5)
6. Trial Resumption Log (Annexure-6)

References

• 21 CFR 312.42 – Clinical Hold and Termination
• FDA – Guidance on Clinical Holds
• ICH GCP E6(R2)

Version: 1.0

Approval Section

Annexures

Annexure-1: Clinical Hold Log

Annexure-2: Site Notification Log

Annexure-3: Remediation Log

Annexure-4: FDA Communication Log

Annexure-5: Subject Communication Log

Annexure-6: Trial Resumption Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for BIMO Inspection Preparation and Response Strategy (FDA Specific)”,
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Standard Operating Procedure for BIMO Inspection Preparation and Response Strategy (FDA Specific)

Purpose

The purpose of this SOP is to establish a standardized process for preparing for, managing, and responding to FDA Bioresearch Monitoring (BIMO) inspections. These inspections ensure protection of human subjects, data integrity, and compliance with regulatory requirements under FDA oversight.

Scope

This SOP applies to sponsors, CROs, investigators, QA teams, and regulatory affairs personnel engaged in U.S. IND clinical trials subject to BIMO inspections. It includes pre-inspection readiness, inspection conduct, communication with inspectors, post-inspection follow-up, and CAPA management.

Responsibilities

• Sponsor: Ensures inspection readiness across all sites and maintains oversight of documentation.
• Investigator: Ensures site-level compliance, staff training, and availability of source records.
• CRO: Provides support for inspection preparation, document retrieval, and site coordination.
• Regulatory Affairs: Manages FDA communications and official responses.
• QA: Conducts mock inspections, audits, and CAPA oversight.

Accountability

The Sponsor’s QA Director is accountable for FDA BIMO inspection readiness and remediation. Investigators are accountable for site-level preparation and subject protection during inspections.

Procedure

1. Pre-Inspection Preparation
1.1 Conduct mock inspections quarterly.
1.2 Verify TMF and ISF completeness and accuracy.
1.3 Train staff on inspection conduct.
1.4 Document in Pre-Inspection Readiness Log (Annexure-1).

2. Notification and Planning
2.1 Upon FDA notification, establish an inspection response team.
2.2 Inform site staff, CRO, and investigators.
2.3 Record in Inspection Notification Log (Annexure-2).

3. Conduct During Inspection
3.1 Ensure inspectors have access to requested documents promptly.
3.2 Maintain an Inspection Document Log (Annexure-3).
3.3 Record all inspector queries in an Inspector Query Log (Annexure-4).

4. FDA Form 483 Handling
4.1 Review Form 483 observations immediately.
4.2 Draft response within 15 business days.
4.3 Record in FDA 483 Response Log (Annexure-5).

5. CAPA Implementation
5.1 Develop CAPA plan for identified deficiencies.
5.2 Implement corrective measures at sponsor, CRO, and site levels.
5.3 Document in CAPA Log (Annexure-6).

6. Post-Inspection Follow-Up
6.1 Submit final remediation updates to FDA.
6.2 Archive inspection materials in TMF/ISF.
6.3 Record in Inspection Follow-Up Log (Annexure-7).

Abbreviations

• SOP: Standard Operating Procedure
• BIMO: Bioresearch Monitoring
• FDA: Food and Drug Administration
• IND: Investigational New Drug
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File
• CAPA: Corrective and Preventive Action

Documents

1. Pre-Inspection Readiness Log (Annexure-1)
2. Inspection Notification Log (Annexure-2)
3. Inspection Document Log (Annexure-3)
4. Inspector Query Log (Annexure-4)
5. FDA 483 Response Log (Annexure-5)
6. CAPA Log (Annexure-6)
7. Inspection Follow-Up Log (Annexure-7)

References

• FDA – Bioresearch Monitoring Program
• 21 CFR Part 312 – IND Regulations
• ICH GCP E6(R2)

Version: 1.0

Approval Section

Annexures

Annexure-1: Pre-Inspection Readiness Log

Annexure-2: Inspection Notification Log

Annexure-3: Inspection Document Log

Annexure-4: Inspector Query Log

Annexure-5: FDA 483 Response Log

Annexure-6: CAPA Log

Annexure-7: Inspection Follow-Up Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for IDE-Specific Safety Reporting and Device Deviations (21 CFR 812)”,
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Standard Operating Procedure for IDE-Specific Safety Reporting and Device Deviations (21 CFR 812)

Purpose

The purpose of this SOP is to define procedures for safety reporting and management of device deviations in clinical trials regulated under the U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) regulations (21 CFR 812). It ensures that unanticipated adverse device effects (UADEs), device malfunctions, and deviations are reported and managed in compliance with regulatory timelines.

Scope

This SOP applies to sponsors, investigators, CROs, QA personnel, and regulatory affairs staff involved in IDE-regulated clinical investigations. It covers unanticipated adverse device effects, device malfunctions, deviations, IRB notifications, sponsor reports to FDA, and inspection readiness.

Responsibilities

• Sponsor: Submits UADE reports to FDA and IRB within required timelines and maintains deviation logs.
• Investigator: Reports all device-related SAEs and deviations to sponsor immediately.
• CRO: Assists in monitoring, reconciliation, and reporting activities.
• Regulatory Affairs: Prepares FDA submissions and maintains inspection readiness.
• QA: Audits safety reporting and device deviation records.

Accountability

The Sponsor’s Device Safety Officer is accountable for ensuring compliance with IDE safety reporting and deviation requirements. Investigators are accountable for site-level reporting accuracy.

Procedure

1. Identification of Device-Related Events
1.1 Investigators must report UADEs and device malfunctions to the sponsor within 24 hours.
1.2 Record in Device Event Log (Annexure-1).

2. Sponsor Evaluation
2.1 Assess severity, causality, and expectedness.
2.2 Document in Device Event Assessment Log (Annexure-2).

3. FDA and IRB Reporting
3.1 Submit UADE reports to FDA and all reviewing IRBs within 10 working days.
3.2 Record in UADE Reporting Log (Annexure-3).

4. Device Deviation Management
4.1 Document deviations from protocol or device instructions in Device Deviation Log (Annexure-4).
4.2 Investigate root causes and apply corrective actions.

5. Corrective and Preventive Actions (CAPA)
5.1 Develop CAPA for recurrent deviations.
5.2 Record in CAPA Log (Annexure-5).

6. Safety Database Management
6.1 Maintain validated device safety database with audit trails.
6.2 Perform quarterly reconciliation with clinical data.
6.3 Record in Database Reconciliation Log (Annexure-6).

7. Inspection Readiness
7.1 Maintain UADE and deviation records for FDA inspections.
7.2 Conduct mock inspections documented in Inspection Readiness Log (Annexure-7).

Abbreviations

• SOP: Standard Operating Procedure
• IDE: Investigational Device Exemption
• UADE: Unanticipated Adverse Device Effect
• FDA: Food and Drug Administration
• IRB: Institutional Review Board
• CRO: Contract Research Organization
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. Device Event Log (Annexure-1)
2. Device Event Assessment Log (Annexure-2)
3. UADE Reporting Log (Annexure-3)
4. Device Deviation Log (Annexure-4)
5. CAPA Log (Annexure-5)
6. Database Reconciliation Log (Annexure-6)
7. Inspection Readiness Log (Annexure-7)

References

• 21 CFR 812 – Investigational Device Exemptions
• FDA – IDE Regulations and Guidance
• ICH GCP E6(R2)

Version: 1.0

Approval Section

Annexures

Annexure-1: Device Event Log

Annexure-2: Device Event Assessment Log

Annexure-3: UADE Reporting Log

Annexure-4: Device Deviation Log

Annexure-5: CAPA Log

Annexure-6: Database Reconciliation Log

Annexure-7: Inspection Readiness Log

Revision History

For more SOPs visit: Pharma SOP

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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