Data Transfer Agreement Clinical Trial Template for Indonesia

The Data Transfer Agreement Clinical Trial is essential for organizations conducting clinical trials in Indonesia where patient data needs to be shared between different entities. This document is specifically designed to comply with Indonesian regulatory requirements, including the Personal Data Protection Law, Health Law, and clinical trial regulations. It should be used whenever clinical trial data, including patient information, research results, and trial outcomes, needs to be transferred between parties such as research institutions, pharmaceutical companies, hospitals, or contract research organizations. The agreement covers crucial aspects such as data security measures, privacy protection, regulatory compliance, breach notification procedures, and specific requirements for handling sensitive medical data in the Indonesian jurisdiction. It also addresses cross-border data transfer requirements when applicable and ensures alignment with international clinical trial standards while maintaining compliance with local regulations.

1. Parties: Identification of the data exporter and data importer, including their legal status and contact details

2. Background: Context of the clinical trial, purpose of data transfer, and relationship between parties

3. Definitions: Definitions of key terms including Clinical Trial Data, Personal Data, Processing, Security Measures, and other relevant terms

4. Scope and Purpose: Detailed description of the data transfer purpose, types of data involved, and processing activities

5. Compliance with Laws: Obligations to comply with Indonesian data protection laws, clinical trial regulations, and other applicable legislation

6. Data Transfer Requirements: Specific requirements for transferring clinical trial data, including security measures and transfer protocols

7. Data Protection Obligations: Obligations regarding data security, confidentiality, and protection of personal information

8. Security Measures: Technical and organizational security measures required for data protection

9. Data Subject Rights: Provisions for protecting rights of clinical trial participants and handling data subject requests

10. Breach Notification: Procedures for handling and reporting data breaches

11. Term and Termination: Duration of the agreement and conditions for termination

12. Return or Destruction of Data: Requirements for handling data after agreement termination

13. Governing Law and Jurisdiction: Specification of Indonesian law as governing law and jurisdiction for disputes