Standard Operating Procedure for Handling, Storage, and Processing of Biological Samples in Clinical Research

Purpose

This SOP outlines the procedures for managing biological samples in clinical trials and clinical studies. The goal is to ensure the integrity and quality of biological samples while maintaining compliance with ethical and regulatory standards.

Scope

This SOP applies to all personnel involved in the handling, storage, and processing of biological samples in clinical trials and clinical studies, including principal investigators, clinical research coordinators, laboratory staff, and other study team members.

Responsibilities

• Principal Investigator (PI): Oversees the management of biological samples in accordance with the study protocol and regulations.
• Clinical Research Coordinators: Coordinate the collection, labeling, and storage of biological samples.
• Laboratory Staff: Process and analyze biological samples according to study requirements and protocols.
• Data Management Team: Ensure accurate and timely data collection and documentation related to biological samples.

Procedure

• Sample Collection and Labeling:
  • Collect biological samples according to the study protocol and participant consent.
  • Label samples accurately and consistently using study identifiers and other relevant information.
  • Document sample collection, including date and time, participant ID, and sample type.
• Sample Storage and Transport:
  • Store samples according to the study protocol and requirements (e.g., temperature control).
  • Transport samples using appropriate methods and containers to maintain sample integrity.
  • Track sample storage and transport to ensure chain of custody and compliance with regulations.
• Sample Processing and Analysis:
  • Process samples in a timely manner and according to study protocols.
  • Perform sample analyses as specified in the study protocol and document results accurately.
  • Maintain laboratory records, including sample processing and analysis logs.
• Quality Control and Assurance:
  • Implement quality control measures for sample handling, processing, and analysis.
  • Conduct regular audits and inspections to ensure compliance with study protocols and regulations.
• Training and Education:
  • Provide training to study personnel on sample management procedures and best practices.
  • Offer ongoing education and support to ensure compliance with sample handling and processing protocols.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator

Documents

• Sample collection and processing logs
• Sample storage and transport records
• Laboratory records and analysis results
• Training materials

References

• Institutional policies for sample management
• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Study protocols and investigator brochures

SOP Version

Version: 1.0