PharmaTrialsCortex Clinical Intelligence
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Acceptable Use Policy

Last updated: v1.0

This Acceptable Use Policy (“AUP”) sets forth the rules and guidelines governing your use of PharmaTrialsCortex, Inc.’s (“PharmaTrialsCortex,” “we,” “us,” or “our”) websites, platform applications (SmartEDC, TMFEye.ai, eCTMS), APIs, and all related services (collectively, the “Services”). This AUP is incorporated by reference into our Terms of Service.

All users of the Services — including administrators, investigators, study coordinators, data managers, monitors, and any other personnel — must comply with this AUP. Violation of this policy may result in suspension or termination of access, as described in the Enforcement section.

Permitted Uses

The Services are designed and intended for use in connection with legitimate clinical trial operations and the evaluation of clinical trial technology. Permitted uses include:

Clinical Trial Operations

  • Configuring and managing clinical studies, including study setup, site management, and visit schedule definition.
  • Designing and building electronic case report forms (eCRFs) using the platform’s form builder tools.
  • Entering, reviewing, verifying, and managing clinical trial data.
  • Generating, responding to, and resolving data queries.
  • Recording and managing adverse events, safety reports, and laboratory data.
  • Applying electronic signatures to clinical data records in accordance with 21 CFR Part 11.
  • Managing informed consent records and participant enrollment.
  • Exporting data in standard formats (CDISC ODM, CSV, SDTM) for analysis and regulatory submission.
  • Managing trial master file documents, including upload, classification, and review.
  • Performing clinical trial management activities, including site performance tracking and milestone management.

Administrative Operations

  • Creating and managing user accounts and role assignments within your organization.
  • Configuring study-level permissions and access controls.
  • Reviewing audit trails and access logs for compliance monitoring.
  • Generating reports and dashboards for study oversight.

Evaluation and Development

  • Evaluating the Services for potential adoption by your organization.
  • Using sandbox or demo environments to test configurations and workflows.
  • Accessing documentation and API references for integration development.

Prohibited Uses

The following activities are strictly prohibited. This list is not exhaustive; we reserve the right to determine, in our reasonable judgment, whether a particular use violates this AUP:

Data Integrity Violations

  • Falsifying clinical trial data: Entering fabricated, fraudulent, or intentionally inaccurate data into the system. This constitutes research fraud and may be reported to relevant regulatory authorities.
  • Tampering with audit trails: Attempting to modify, delete, circumvent, or falsify audit trail records. Audit trails are immutable by design as required by 21 CFR Part 11 Section 11.10(e).
  • Unauthorized signatures: Applying an electronic signature on behalf of another person or using another person’s credentials to sign records.
  • Bypassing edit checks: Deliberately circumventing data validation rules or edit checks designed to ensure data quality.
  • Unauthorized data modification: Modifying locked or verified CRF entries without following the proper amendment workflow.

Security Violations

  • Unauthorized access: Attempting to access accounts, data, systems, or networks for which you do not have authorization.
  • Credential sharing: Sharing your login credentials with any other person or using another person’s credentials. Each user must have a unique individual account.
  • Security testing without authorization: Performing vulnerability scanning, penetration testing, or security assessments against the Services without prior written authorization from PharmaTrialsCortex (see our Security Policy for our responsible disclosure program).
  • Malicious code: Uploading, transmitting, or introducing viruses, malware, ransomware, trojan horses, worms, or other harmful code.
  • Network interference: Attempting to interfere with the proper operation of the Services through denial-of-service attacks, packet flooding, or other disruptive techniques.
  • Spoofing or impersonation: Forging headers, impersonating another person or entity, or misrepresenting your identity or affiliation.
  • Regulatory non-compliance: Using the Services in a manner that violates applicable clinical trial regulations, including 21 CFR Part 11, ICH-GCP, GDPR, HIPAA, or other applicable laws.
  • Unauthorized data processing: Processing personal data for purposes not authorized by the data controller or not covered by an appropriate legal basis.
  • Export control violations: Using the Services in violation of export control or sanctions laws, including transmitting controlled data to sanctioned countries or individuals.
  • Intellectual property infringement: Uploading content that infringes the intellectual property rights of third parties.

Platform Abuse

  • Excessive resource consumption: Using automated tools, bots, or scripts in a manner that places unreasonable load on the Services or degrades performance for other users.
  • Data scraping: Systematically extracting data from the Services using automated means for purposes unrelated to your authorized use.
  • Reselling access: Reselling, sublicensing, or providing access to the Services to third parties without authorization.
  • Non-clinical use: Using the Services for purposes unrelated to clinical trial operations, such as general-purpose data storage, personal use, or marketing campaigns.
  • Circumventing access controls: Attempting to bypass RBAC permissions, site-scoping, or other access restrictions to view data outside your authorized scope.

Enforcement

Investigation

PharmaTrialsCortex may investigate suspected violations of this AUP. We may review activity logs, audit trails, and system events to determine whether a violation has occurred. We will conduct investigations in a manner that is proportionate to the suspected violation and consistent with applicable law.

Remedial Actions

Upon confirming a violation, we may take one or more of the following actions, depending on the severity and nature of the violation:

  1. Warning: Issue a written warning to the user and their organization, specifying the violation and required corrective action.
  2. Suspension: Temporarily suspend the user’s access to the Services, pending investigation or remediation.
  3. Termination: Permanently terminate the user’s access to the Services.
  4. Account-level action: Suspend or terminate the Customer’s entire account if violations are widespread, systemic, or directed by the organization.
  5. Regulatory reporting: Report suspected research fraud, data falsification, or regulatory violations to relevant authorities, including the FDA, EMA, OHRP, or institutional review boards.
  6. Legal action: Pursue legal remedies, including seeking injunctive relief or damages.

Due Process

Except in cases of imminent harm or legal obligation, we will:

  • Provide the affected user and their organization with notice of the suspected violation.
  • Allow a reasonable opportunity to respond and provide an explanation.
  • Consider all relevant circumstances before taking enforcement action.

Audit Trail Preservation

All enforcement actions are recorded in the system’s audit trail. Records of policy violations and enforcement actions are retained for the duration of the applicable regulatory retention period.

Reporting

How to Report Violations

If you become aware of a violation of this AUP, please report it promptly:

When reporting a violation, please include:

  • Your name and contact information.
  • A description of the suspected violation.
  • The date, time, and circumstances of the incident.
  • Any supporting evidence (screenshots, log entries, etc.).

Whistleblower Protection

PharmaTrialsCortex is committed to protecting individuals who report violations in good faith. We will not retaliate against any person for reporting a suspected violation of this AUP, applicable law, or regulatory requirement. Reports may be made anonymously.

Cooperation with Authorities

We cooperate with law enforcement and regulatory authorities investigating violations of applicable law. We may disclose information related to policy violations as required by law, regulation, or legal process.

For questions about this Acceptable Use Policy, contact us at support@pharmatrialscortex.com.