Standard Operating Procedure (SOP) for Investigational Product Accountability

Introduction:
Ensure the integrity, traceability, and compliance of investigational products (IP) used in clinical trials with our Standard Operating Procedure (SOP) for Investigational Product Accountability. This SOP is designed for clinical research organizations, sponsors, and sites operating in regulated environments to manage the receipt, storage, dispensing, reconciliation, and disposal of IP in accordance with ICH GCP and applicable regulatory requirements.

Overview:
The SOP for Investigational Product Accountability outlines a standardized approach to tracking the lifecycle of investigational products—from receipt to final disposition. It supports rigorous documentation, prevents errors, and ensures that investigational products are handled in a controlled and compliant manner throughout the clinical trial process.

Key Sections Included in the SOP:

1. Purpose:
   Establishes the importance of IP accountability in safeguarding subject safety, maintaining study integrity, and complying with regulatory and sponsor requirements.
2. Scope:
   Defines the clinical trial phases and types of investigational products covered, including drugs, biologics, and devices.
3. Responsibilities:
   Clarifies the duties of principal investigators, pharmacists, clinical trial coordinators, monitors, and other relevant personnel in managing IP.
4. Receipt of Investigational Product:
   • Details procedures for inspecting, documenting, and verifying shipment contents upon delivery.
   • Includes instructions for logging IP into inventory systems and notifying the sponsor or CRO.
5. Storage and Access Control:
   • Describes conditions for proper storage (temperature, humidity, light) and outlines requirements for access restriction and security.
6. Dispensing Procedures:
   • Provides guidelines for labeling, preparing, and dispensing IP to subjects in accordance with protocol-specific requirements.
   • Includes chain-of-custody documentation and dosage reconciliation.
7. Inventory Reconciliation:
   • Explains periodic and end-of-study reconciliation processes to account for all IP (used, unused, returned, or destroyed).
   • Requires investigation and documentation of any discrepancies.
8. Returns and Disposal:
   • Specifies procedures for returning unused IP to the sponsor or authorized vendor, or for onsite destruction when permitted.
   • Emphasizes compliant documentation and witness procedures.
9. Record Keeping and Documentation:
   • Highlights the use of inventory logs, accountability records, temperature logs, and subject-specific dispensing logs.
   • Ensures documentation is audit-ready and retained as per regulatory timelines.
10. Monitoring and Audit Readiness:

• Describes how monitors and auditors will review IP accountability during routine visits or inspections.

1. Deviation Management:

• Provides steps for identifying, investigating, and documenting deviations related to IP handling.

1. Training and Competency:

• Requires training for all personnel involved in IP management, with documentation of completed training and competency assessments.

Why Download This SOP?

• Support Regulatory Compliance: Meets FDA, EMA, and ICH GCP requirements for investigational product tracking and control.
• Ensure Subject Safety: Guarantees proper handling, storage, and administration of IP to protect clinical trial participants.
• Maintain Trial Integrity: Prevents IP-related errors that could compromise study outcomes.
• Promote Accountability: Establishes traceability for every unit of IP from receipt to destruction.
• Facilitate Audits and Inspections: Includes robust documentation practices to demonstrate compliance during sponsor or regulatory reviews.

Support and Contact Information:
For questions or additional guidance on investigational product accountability procedures, please reach out to our support team. We’re here to help you meet the highest standards of clinical trial management and regulatory compliance.