Standard Operating Procedure for Record-Keeping in Clinical Research

Purpose

This SOP establishes the procedures for documentation and record-keeping in clinical trials and clinical studies. The goal is to ensure the maintenance of accurate, complete, and up-to-date records in compliance with regulatory requirements and Good Clinical Practice (GCP) standards.

Scope

This SOP applies to all personnel involved in documentation and record-keeping activities, including principal investigators, clinical research coordinators, data managers, and other study team members.

Responsibilities

• Principal Investigator (PI): Ensures that documentation and record-keeping comply with the study protocol and regulatory requirements.
• Clinical Research Coordinators: Maintain study records and source documentation according to regulatory and institutional standards.
• Data Managers: Manage data-related records and ensure data integrity and accuracy.

Procedure

• Record-Keeping:
  • Maintain accurate and complete records of all study activities, including participant recruitment, consent, and data collection.
  • Ensure that records are kept in an organized manner and easily accessible for review.
  • Maintain source documentation that supports study data and activities.
• Documentation:
  • Document all study procedures, events, and observations in case report forms (CRFs) and other study documents.
  • Record deviations from the study protocol and report them according to regulatory requirements.
  • Document adverse events and safety monitoring activities.
  • Ensure that all documentation is signed, dated, and authenticated as required.
• Data Management and Storage:
  • Maintain data logs and ensure the security and confidentiality of study data.
  • Store electronic records in secure systems with appropriate access controls.
  • Archive records in compliance with regulatory and institutional requirements.
• Quality Control and Assurance:
  • Conduct regular audits and checks to verify the accuracy and completeness of records.
  • Correct any errors or discrepancies in records promptly and document the corrections.
• Record Retention:
  • Retain study records according to regulatory requirements and institutional policies.
  • Archive records in a secure and accessible location for the required retention period.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• GCP: Good Clinical Practice
• CRF: Case Report Form

Documents

• Study records (e.g., recruitment, consent, data collection)
• Case report forms (CRFs)
• Source documentation
• Data logs and storage records
• Quality control and assurance reports

References

• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Institutional policies and procedures

SOP Version

Version: 1.0