Standard Operating Procedure for Data Privacy and Confidentiality

Purpose

This SOP outlines the procedures for ensuring data privacy and confidentiality in clinical trials and clinical studies. The goal is to protect participants’ personal and sensitive information in compliance with legal, ethical, and regulatory standards.

Scope

This SOP applies to all personnel involved in handling participant data in clinical trials and clinical studies, including principal investigators, clinical research coordinators, data managers, and other study staff.

Responsibilities

• Principal Investigator (PI): Oversees data privacy and confidentiality practices in the study and ensures compliance with regulations.
• Data Managers: Handle data collection, storage, and access, and ensure data is protected according to standards.
• Study Staff: Follow data privacy and confidentiality procedures during data handling, processing, and reporting.
• IT Personnel: Provide technical support to ensure secure storage, transmission, and access of participant data.

Procedure

• Data Collection and Use:
  • Collect only the data necessary for the study and minimize data use where possible.
  • Ensure data is de-identified or pseudonymized when possible to protect participant privacy.
• Data Storage and Access:
  • Store data securely in compliance with regulatory and institutional standards.
  • Restrict access to participant data to authorized personnel only.
• Data Transmission:
  • Use secure methods for transmitting data, such as encrypted channels or secure file transfer protocols.
  • Ensure data is not transmitted to unauthorized parties or third parties