PRIV- 37 – Regulator Transfer Approval

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What is this control about?

Implementing the control of ‘Regulator Transfer Approval’ is important to ensure that any transfers of data to regulatory authorities or third-party entities are conducted with proper approval and adherence to relevant laws, regulations, and organizational policies. This control is particularly crucial when an organization is required to share sensitive information with government agencies, regulatory bodies, or external entities for compliance, reporting, or investigation purposes.

Available tools in the marketplace

Tools:
  • N/A – No tools for this control

Available templates

TrustCloud has a curated list of templates internally or externally sourced to help you get started. Click on the link for a downloadable version:

  • Leverage this data transfer policy example .Privacy documents are best to be drafted by your Legal team

Control implementation

Here are some guidelines to implement an effective records of Regulator Transfer Approval program:

  • Identify Applicable Regulations: Determine the relevant data protection and privacy regulations that apply to the organization’s industry and geographical location. Understand the requirements for data transfer to regulatory authorities or third-party entities.
  • Define Data Categories: Categorize the data based on its sensitivity and regulatory requirements. Identify data that requires special handling and approval before transfer to regulators or external parties.
  • Establish Data Transfer Policy: Develop a comprehensive data transfer policy that outlines the procedures for sharing data with regulatory authorities. Include criteria for determining when transfer approval is required and the roles and responsibilities of individuals involved in the approval process.
  • Design Approval Workflow: Create an approval workflow that defines the steps involved in obtaining regulator transfer approval. Assign appropriate personnel responsible for reviewing and approving data transfers.
  • Implement Access Controls: Set up access controls to restrict data access to authorized personnel only. Use role-based access to ensure that only authorized individuals can initiate and approve data transfers.
  • Integrate with Data Management Systems: Integrate the regulator transfer approval process with data management systems, such as data governance or data classification tools. This integration will streamline the process and enhance data visibility.
  • Document Data Transfers: Maintain detailed records of all data transfers made to regulatory authorities or third-party entities. Document the approvals obtained, data categories transferred, dates, and relevant compliance details.
  • Address Non-Compliance: In case of any non-compliance with the regulator transfer approval process, take corrective actions promptly. Investigate incidents and implement measures to prevent recurrence.
  • Monitor and Report: Continuously monitor the regulator transfer approval process to ensure it is functioning effectively. Generate reports on data transfers, approvals, and any exceptions identified during audits.

What evidence do auditors look for?

Most auditors, at a minimum, are looking for the below-suggested action:

  • Data Transfer Policy and Procedures:A documented data transfer policy that outlines the organization’s approach to sharing data with regulatory authorities or third-party entities. Procedures and guidelines for obtaining approval before transferring data, specifying the roles and responsibilities of individuals involved in the approval process.
  • Regulator Transfer Approval Workflow: A documented approval workflow that illustrates the steps involved in obtaining regulator transfer approval. Evidence of designated personnel responsible for reviewing and approving data transfers.

Evidence example

For the suggested action, an example is provided below:

  • Data Transfer Policy and Procedures

Leverage this data transfer policy example .Privacy documents are best to be drafted by your Legal team

  • Regulator Transfer Approval Workflow

Screenshot source

PRIV 37 1
Recently, there has been a growing trend in clinical development to utilize real-world data (RWD) to improve the efficiency of drug/medical device development.

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