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Terms of Use

# Resources
Last updated: 04/14/2026

Legal terms and conditions governing the use of the ClinicalDataS Electronic Data Capture (EDC) and Clinical Study Management platform.

Overview​

Welcome to ClinicalDataS. These Terms of Use ("Terms") govern your access to and use of the ClinicalDataS Electronic Data Capture (EDC) platform, including all associated modules (e.g., Randomization, IMP Management, eConsent, Medical Coding, AI Assistant), websites, and services (collectively, the "Service").

By accessing or using ClinicalDataS, you agree to be bound by these Terms. If you are using the Service on behalf of a Sponsor, Contract Research Organization (CRO), or Investigational Site ("Organization"), you represent and warrant that you have the authority to bind that Organization to these Terms.

1. Description of Service​

ClinicalDataS is a cloud-based Software-as-a-Service (SaaS) platform designed to facilitate clinical trial operations, including but not limited to:

  • Electronic Data Capture (EDC): Case Report Form (CRF) design, data entry, and validation.
  • Clinical Supply Management: Investigational Medicinal Product (IMP) tracking, randomization (RTSM), and dispensing.
  • Participant Engagement: Electronic Consent (eConsent) and Survey management.
  • Monitoring & Compliance: Source Data Verification (SDV), Query Management, and comprehensive Audit Trails.

2. User Accounts & Security Responsibilities​

Given the sensitive nature of clinical trial data, strict security protocols are enforced. Users agree to the following:

  • Account Credentials: You are responsible for maintaining the confidentiality of your login credentials.
  • Mandatory Security Measures: You agree to comply with your Organization's and ClinicalDataS's security policies, which may include mandatory Two-Factor Authentication (2FA), complex password policies, and session timeout requirements.
  • Role-Based Access: You shall only access data and perform actions (e.g., Data Entry, SDV, Unblinding) that are explicitly permitted by your assigned Role-Based Access Control (RBAC) permissions. Attempting to bypass these restrictions is strictly prohibited.
  • Notification of Breach: You must immediately notify your System Administrator and ClinicalDataS support if you suspect any unauthorized use of your account or security breach.

3. Regulatory Compliance & Data Roles​

ClinicalDataS is designed to support compliance with global clinical regulations (e.g., ICH-GCP, GDPR, HIPAA, 21 CFR Part 11 / EU Annex 11). However, the Service operates under a shared responsibility model:

RoleResponsibility
Data Controller (Sponsor / Site)Responsible for the legality of data collection, obtaining participant informed consent (via eConsent or paper), validating study designs (e.g., Randomization algorithms, Rule Studio logic), and ensuring data integrity.
Data Processor (ClinicalDataS)Responsible for providing the secure infrastructure, immutable Audit Trails, electronic signature mechanisms, and system availability to process data strictly according to the Controller's configuration.

Note: ClinicalDataS provides the tools for electronic signatures and audit logging, but the Data Controller is responsible for defining the business logic and ensuring the system is validated for its intended use in the clinical trial.

4. Acceptable Use & Restrictions​

You may not use the Service to engage in any activity that violates local, national, or international laws. Specifically, you agree NOT to:

  • Reverse Engineer: Decompile, reverse engineer, or attempt to extract the source code of the ClinicalDataS platform or its underlying algorithms (e.g., Randomization generation logic).
  • Bypass Security: Attempt to probe, scan, or test the vulnerability of the Service or breach any security or authentication measures.
  • Introduce Malicious Code: Upload viruses, trojans, or any malicious scripts via the File Input, eConsent uploads, or AI Chatbot interfaces.
  • Misuse AI Features: Rely solely on the AI Data Entry Assistant for clinical decision-making. The AI is an assistive tool; the end-user is fully responsible for verifying the accuracy of all data entered into the CRFs.
  • Share PHI Inappropriately: Use the platform to store or transmit Personally Identifiable Information (PHI) in unstructured formats (e.g., free-text notes, unapproved attachments) if such action violates your Organization's PHI Masking configurations.

5. Intellectual Property Rights​

  • Platform Ownership: ClinicalDataS and its licensors own all rights, title, and interest in and to the Service, including the UI/UX, Rule Engine, Form Builder, and underlying code.
  • Clinical Data Ownership: Your Organization (the Data Controller) retains all ownership rights to the clinical data, subject records, and study configurations entered into the platform. We do not claim any ownership over your clinical trial data.
  • Feedback: If you provide suggestions or feedback regarding the Service, you grant us a perpetual, royalty-free license to use such feedback to improve the platform.

6. Electronic Records & Signatures​

ClinicalDataS supports electronic records and electronic signatures in compliance with 21 CFR Part 11 and EU Annex 11 guidelines.

  • Audit Trails: The system maintains secure, computer-generated, time-stamped audit records that allow for the reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record. These audit trails are immutable and cannot be altered by any user.
  • Signatures: Electronic signatures (e.g., CRF Sign-off, eConsent signatures) are linked to their respective electronic records to ensure that they cannot be excised, copied, or otherwise falsified.

7. Third-Party Integrations & AI​

The Service may integrate with third-party services to enhance functionality:

  • AI Assistant: The integrated AI Chatbot processes CRF context to assist with data entry. Data sent to the AI is anonymized/standardized where possible. ClinicalDataS is not liable for AI-generated hallucinations; users must verify all AI suggestions.
  • Cloud Storage & Dictionaries: Integrations with cloud storage (e.g., AWS S3 for attachments/eConsent) and medical dictionaries (e.g., MedDRA, WHODrug) are subject to the respective third parties' terms and uptime.

8. Limitation of Liability​

TO THE MAXIMUM EXTENT PERMITTED BY LAW, CLINICALDATAS SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING BUT NOT LIMITED TO LOSS OF DATA, DELAYS IN CLINICAL TRIAL TIMELINES, OR REGULATORY FINES ARISING OUT OF YOUR USE OR INABILITY TO USE THE SERVICE.

Clinical Data Validation: While ClinicalDataS provides robust Rule Engines and Edit Checks, it is the sole responsibility of the Data Controller to validate that the system's logic correctly aligns with the clinical study protocol before going live.

9. Modifications to the Service & Terms​

  • Service Updates: We continuously improve the platform (as detailed in our Release Notes). We reserve the right to modify, suspend, or discontinue any part of the Service with reasonable notice.
  • Terms Updates: We may revise these Terms from time to time. Material changes will be communicated via the System Dashboard, Email Log notifications, or direct email to the System Administrators.

⚖️ Disclaimer: This document is a template intended for SaaS clinical platforms. It does not constitute legal advice. Please consult with your organization's legal and regulatory affairs teams to ensure these Terms meet your specific jurisdictional and operational requirements before publishing.

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