Standard Operating Procedure for Managing Data in Clinical Research

Purpose

This SOP establishes the procedures for data collection and management in clinical trials and clinical studies. The aim is to ensure data integrity, accuracy, and compliance with regulatory requirements throughout the study.

Scope

This SOP applies to all personnel involved in data collection and management, including principal investigators, clinical research coordinators, data managers, and other study team members.

Responsibilities

• Principal Investigator (PI): Provides oversight and ensures data collection and management adhere to the study protocol and regulatory standards.
• Clinical Research Coordinators: Collect and manage data according to study protocols.
• Data Managers: Oversee data management activities, including data entry, cleaning, and storage.

Procedure

• Data Collection:
  • Collect data in accordance with the study protocol and case report forms (CRFs).
  • Use standardized data collection tools and techniques to ensure data consistency.
  • Record data promptly and accurately during study visits and assessments.
  • Obtain and verify data directly from the source, if possible.
• Data Management:
  • Enter data into the study database in a timely and accurate manner.
  • Perform data cleaning to identify and correct errors, inconsistencies, or missing data.
  • Maintain an audit trail to document data changes and updates.
  • Backup data regularly and ensure data security and confidentiality.
• Data Monitoring:
  • Conduct regular data monitoring to ensure data quality and compliance with the protocol.
  • Address data discrepancies promptly and document corrective actions.
  • Work with the study team to resolve data-related issues.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRF: Case Report Form
• ICH-GCP: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice

Documents

• Case report forms (CRFs)
• Data collection tools
• Data management plans
• Data entry and cleaning logs
• Data monitoring reports

References

• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Institutional policies and procedures
• Data management standards and best practices

SOP Version

Version: 1.0