Terms and Conditions for Authorized Users of the Enlighten Clinical Solutions EDC Platform

1.0 Introduction 

1.1 Purpose of the Terms

This document outlines the Platform Terms and Conditions governing the access and use of the Enlighten Clinical Solutions Electronic Data Capture (EDC) Platform (“Platform”) by authorized users, including but not limited to sponsors, CROs, data managers, clinical site staff, and other designated clinical trial personnel.

By accessing the Platform, users acknowledge that they are authorized to do so by their Sponsor or Contracting Entity and must comply with the usage responsibilities, compliance obligations, and security measures outlined herein.

1.2 Scope of Use

• The Platform is designed exclusively for clinical research purposes and may only be used by individuals authorized by the Sponsor or Contracting Entity.
• Users are responsible for ensuring that all data entered, modified, or reviewed within the Platform complies with clinical research regulations, sponsor protocols, and applicable laws.
• Any unauthorized access, misuse, or deviation from the intended research purpose is strictly prohibited and may result in account suspension or legal action.

1.3 Acknowledgment of Terms

By using the Platform, users acknowledge and agree to these EDC Platform Terms and Conditions. Continued use of the Platform constitutes an understanding that these terms govern access and usage, including any future modifications communicated by Enlighten Clinical Solutions.

2.0 Definitions

2.1 Sponsor

The organization responsible for initiating, funding, and overseeing the clinical trial. This may include a pharmaceutical company, medical device company, biotech firm, or Contract Research Organization (CRO). In some cases, a third-party entity contracted by the sponsor may assume certain oversight and operational responsibilities.

2.2 Contracting Entity

The organization that has entered into an agreement with Enlighten Clinical Solutions for the use of the Platform. This may be the Sponsor directly or a third party acting on behalf of the Sponsor, such as a CRO, Site Management Organization (SMO), or clinical research vendor.

2.3 Authorized Users

Individuals designated by the Contracting Entity (which may be the Sponsor or an authorized third party) to access and use the Platform for clinical trial-related activities, including:

• Data Managers – Oversee data collection and quality control.
• Clinical Site Staff – Investigators, coordinators, and other personnel entering or verifying patient data.
• Monitors (CRAs) – Responsible for trial oversight and data verification.
• Regulatory Auditors – Individuals designated by regulatory agencies or the Sponsor to review Platform data for compliance but do not directly access the Platform unless authorized by the Sponsor or Contracting Entity.

2.4 Platform

The Enlighten Clinical Solutions Electronic Data Capture (EDC) Platform, including its software, databases, and related components, used for managing clinical trial data.

2.5 Compliance Regulations

Regulatory standards governing clinical trials and data management, including but not limited to:

• 21 CFR Part 11 – FDA guidelines for electronic records and signatures.
• GxP – Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and other applicable standards.
• GDPR – Data protection laws applicable to European Union (EU) participants.
• HIPAA – U.S. regulations for patient data protection.

3.0 User Access and Responsibilities

3.1 Authorized Access

• Access to the Platform is granted and revoked solely at the discretion of the Sponsor or Contracting Entity.
• Each user is granted role-based access in accordance with their responsibilities within the clinical trial.
• Users must not share login credentials or allow unauthorized individuals to access the Platform.

3.2 Account Security

• Users are responsible for maintaining the confidentiality of their login credentials.
• Multi-factor authentication (MFA) must be enabled where applicable.
• Any suspected unauthorized access must be reported to the Platform administrator immediately.

3.3 Proper Use of the Platform

• Users must ensure that all data entered is accurate, complete, and truthful, in accordance with regulatory requirements.
• Any attempt to manipulate, falsify, or delete clinical trial data is strictly prohibited.
• Users must comply with 21 CFR Part 11, GxP, GDPR, and HIPAA standards for electronic records and data integrity.

4.0 Data Privacy and Protection

• All clinical trial data entered into the Platform remains the property of the Sponsor or Contracting Entity.
• Enlighten Clinical Solutions does not access, process, or analyze data for any purpose outside of providing the technical infrastructure and security measures necessary for platform functionality.
• The Sponsor or Contracting Entity is responsible for determining data retention, deletion, and access policies in compliance with applicable regulations.

5.0 Security Policies

• The Platform implements role-based access controls, end-to-end encryption, and audit logging to protect clinical trial data.
• Users must not attempt to bypass, disable, or interfere with security measures.
• Any suspected security breach or unauthorized access must be reported immediately.

6.0 Compliance with Clinical Trial Regulations

• The Platform maintains immutable audit trails for technical compliance and security purposes.
• Responsibility for clinical trial regulatory compliance, including protocol adherence and data integrity, lies with the Sponsor or Contracting Entity.
• Users must follow Sponsor-imposed procedures and regulatory obligations when utilizing the Platform.

7.0 Service Disclaimer and Support Commitment

• Enlighten Clinical Solutions strives to maintain 99% uptime for the Platform, excluding scheduled maintenance and external disruptions beyond our control. While we aim for continuous availability, absolute uptime is not guaranteed.
• Users are responsible for ensuring that their use of the Platform aligns with clinical trial protocols, guidelines, and regulatory requirements.
• Contractual arrangements between Enlighten Clinical Solutions and the Sponsor or Contracting Entity do not alter user responsibilities under these EDC Platform Terms and Conditions.

8.0 Contact Information

• Technical Support Page: Users can submit inquiries via the Enlighten Clinical Solutions Support Page on our website.
• Sponsor or Contracting Entity Support: Users should first check with their Sponsor or Contracting Entity for trial-specific concerns before escalating technical issues.
• Regulatory and Security Issues: Any security or compliance matters should be directed to the Sponsor or Contracting Entity first.