Terms of Service

Last updated: January 2025

1. Acceptance of Terms

By accessing and using SmartSource Clinical Trial Management System ("the Service"), you agree to be bound by these Terms of Service. If you do not agree to these terms, please do not use the Service.

2. Description of Service

SmartSource is a site-based Clinical Trial Management System (CTMS) designed to facilitate the management of clinical trials, including but not limited to:

  • Study and protocol management
  • Site coordination and administration
  • Document management and electronic signatures
  • Delegation of Authority (DOA) tracking
  • Audit trail and compliance reporting
  • User and role management

3. User Accounts and Responsibilities

You are responsible for maintaining the confidentiality of your account credentials and for all activities that occur under your account. You agree to:

  • Provide accurate and complete information during registration
  • Keep your login credentials secure and confidential
  • Notify us immediately of any unauthorized use of your account
  • Use the Service only for lawful purposes and in accordance with applicable regulations

4. Regulatory Compliance

The Service is designed to support compliance with applicable clinical trial regulations, including but not limited to:

  • 21 CFR Part 11 (Electronic Records; Electronic Signatures)
  • ICH E6(R2) Good Clinical Practice Guidelines
  • ALCOA+ principles for data integrity
  • HIPAA requirements for protected health information

Users are responsible for ensuring their use of the Service complies with all applicable laws and regulations in their jurisdiction.

5. Data Ownership and Use

All clinical trial data entered into the Service remains the property of the respective organization. We do not claim ownership of your data. We may use aggregated, anonymized data for service improvement and analytics purposes.

6. System Availability

We strive to maintain 99.9% system availability. However, we reserve the right to perform scheduled maintenance and updates. Users will be notified in advance of any planned downtime that may affect service availability.

7. Audit Trails

The Service maintains comprehensive audit trails of all user actions and data modifications in compliance with regulatory requirements. These audit trails are immutable and cannot be modified or deleted.

8. Intellectual Property

The Service, including its software, design, and documentation, is protected by intellectual property laws. You may not copy, modify, distribute, or reverse engineer any part of the Service without prior written consent.

9. Limitation of Liability

To the maximum extent permitted by law, SmartSource shall not be liable for any indirect, incidental, special, consequential, or punitive damages arising from your use of the Service.

10. Termination

We reserve the right to suspend or terminate access to the Service for violation of these terms or for any other reason at our discretion. Upon termination, your right to use the Service will immediately cease.

11. Changes to Terms

We may update these Terms of Service from time to time. Users will be notified of significant changes. Continued use of the Service after changes constitutes acceptance of the updated terms.

12. Contact Information

For questions about these Terms of Service, please contact us at:

Email: legal@smartsource.com
Address: SmartSource Inc., Clinical Trial Solutions