Terms & Conditions

Welcome to USDMPlay.

These Terms & Conditions (“Terms”) govern your access to and use of the USDMPlay website, application, educational content, interactive tools, AI-enabled functionality, demonstrations and related services (collectively, the “Platform”).

USDMPlay is a free, independent, community-oriented educational and demonstration platform operated from Belgium.

By creating an account, accessing the interactive application or otherwise using USDMPlay, you agree to these Terms.

If you do not agree with these Terms, please do not use the Platform.

1. About USDMPlay

USDMPlay is a free, hands-on education and demonstration platform designed to help members of the clinical research community learn, explore and better understand the CDISC Unified Study Definitions Model (USDM) and its potential role within Digital Data Flow and downstream automation.

USDMPlay may allow users to:

• upload publicly available or non-production USDM JSON files;
• explore USDM information through relational tables;
• view USDM information through UML-style representations;
• explore study design information;
• explore Schedule of Activities;
• explore Patient Journey concepts;
• explore SDTM Trial Design use cases;
• explore ICH M11, Define.xml and other downstream automation concepts;
• create or review mapping information;
• interact with AI-enabled functionality such as Ask USDM;
• access tutorials, examples, articles and educational resources; and
• explore other USDM-related demonstrations made available through the Platform.

USDMPlay is intended to complement official standards, documentation and training. It does not replace them.

2. Owner and Operator

USDMPlay is owned and operated by:

Rajesh Saha
Belgium

Rajesh Saha is responsible for the operation and administration of the Platform and acts as the data controller for personal information processed in connection with USDMPlay.

Questions concerning the Platform, these Terms or privacy may be directed to:

support@usdmplay.com

Further information regarding the processing of personal data is provided in the USDMPlay Privacy Policy.

3. Free Community and Educational Platform

USDMPlay is provided as a free educational and demonstration service for the clinical research and USDM community.

Users are not charged a subscription fee or usage fee for accessing the current Platform.

USDMPlay is not presented as a commercial clinical software product or enterprise production system.

The fact that USDMPlay is provided free of charge does not limit any rights that cannot lawfully be excluded under applicable Belgian or European Union law.

4. Educational and Demonstration Use Only

USDMPlay is intended exclusively for:

• education;
• learning;
• experimentation;
• demonstration;
• research into USDM concepts;
• exploration of Digital Data Flow concepts; and
• evaluation of potential downstream automation approaches.

USDMPlay is not a validated clinical system.

It is not intended to operate as:

• an Electronic Data Capture system;
• a Clinical Trial Management System;
• a regulated clinical data repository;
• a production protocol-authoring system;
• a regulatory submission system;
• a validated statistical or clinical programming environment;
• a production standards-management system; or
• any other system upon which regulated clinical operations depend.

No representation is made that USDMPlay satisfies requirements applicable to validated or regulated systems, including GxP-related requirements, electronic-record requirements or organisation-specific validation procedures.

5. No Affiliation or Endorsement

USDMPlay is an independent initiative.

USDMPlay is not affiliated with, sponsored by, authorised by, certified by or endorsed by CDISC, TransCelerate BioPharma, ICH, any regulatory authority or any other standards organisation, unless explicitly stated otherwise.

References to CDISC, USDM, SDTM, CDASH, Define.xml, TransCelerate, Digital Data Flow, ICH M11 and related standards, organisations, initiatives or terminology are provided for educational and informational purposes.

Official and normative information should always be obtained from the relevant standards organisation or authoritative source.

6. Eligibility to Use USDMPlay

USDMPlay is primarily intended for adults involved in or interested in clinical research, clinical data standards, study design, technology or related disciplines.

By creating an account, you confirm that you are at least 18 years old and capable of accepting these Terms.

If you use USDMPlay in connection with your employment or professional activities, you are responsible for ensuring that your use complies with the policies, confidentiality requirements and information-security requirements of your employer or organisation.

7. User Accounts

Certain features of USDMPlay require a registered account.

You agree to provide accurate information when registering and to use your account only for legitimate purposes.

You are responsible for activity undertaken through your account.

You must not:

• impersonate another person;
• register using another person’s identity without permission;
• intentionally provide false or misleading registration information; or
• provide another person with unauthorised access to your account.

USDMPlay reserves the right to suspend or restrict an account where reasonably necessary for security, misuse prevention or enforcement of these Terms.

8. Passwordless Login and OTP Authentication

USDMPlay uses a One-Time Password (OTP) authentication mechanism.

USDMPlay does not require users to create a traditional password for their USDMPlay account and does not store a user password for authentication.

Users are responsible for maintaining control of the email account or other authentication channel used to receive their OTP.

You should never provide an OTP received for USDMPlay authentication to another person.

9. What Data You May Upload

USDMPlay is designed only for publicly available or non-production USDM information.

You may upload information that is:

• publicly available;
• synthetic;
• created for learning or demonstration;
• appropriately anonymised where applicable;
• non-production study information that you are authorised to use; or
• otherwise information that you have the legal and contractual right to process through USDMPlay.

You are responsible for determining whether the information you upload is suitable for use within the Platform.

10. Information You Must Not Upload

USDMPlay is not intended for confidential, sensitive, patient-level or production clinical information.

You must not upload or enter:

• identifiable patient or clinical trial participant information;
• personal health information;
• special-category personal data relating to study participants;
• production clinical trial data;
• sponsor-confidential study data;
• unpublished proprietary protocol information that you are not authorised to disclose;
• confidential information belonging to your employer, customer, sponsor or another third party;
• credentials, passwords, authentication tokens or security keys;
• information subject to confidentiality obligations that prohibit its use in external systems;
• malicious software, executable code or harmful files;
• information that infringes intellectual-property rights; or
• information whose processing would violate applicable law.

If you are uncertain whether information is confidential, sensitive, personal or restricted, do not upload it to USDMPlay.

11. No Processing Agreement for Regulated Clinical Data

USDMPlay does not offer itself as a regulated clinical-data processor, clinical-trial data hosting provider or production clinical technology vendor.

These Terms do not constitute a Data Processing Agreement for the processing of patient-level, regulated, sponsor-confidential or production clinical trial data.

Users must not use USDMPlay as a substitute for an appropriately contracted and validated clinical technology environment.

12. Ownership of Your Uploaded Data

You retain any ownership or other rights you have in the information you upload to USDMPlay.

Uploading information to USDMPlay does not transfer ownership of that information to USDMPlay.

By uploading information, you provide USDMPlay with a limited permission to technically:

• receive;
• store;
• parse;
• structure;
• transform;
• query;
• display; and
• otherwise process

the information solely as reasonably necessary to provide the functionality requested by you through the Platform.

You represent that you have the right and authority to provide the information to USDMPlay for these purposes.

13. Study and Project Data Retention

USDMPlay operates as an educational community platform with limited infrastructure and is not intended to provide long-term data storage.

If you do not successfully log in to your USDMPlay account for 10 consecutive days, the study and project information associated with your account may be automatically deleted.

This includes, where applicable:

• uploaded USDM JSON files;
• all studies created within USDMPlay;
• information extracted from uploaded USDM JSON;
• information stored in the application database based upon that USDM JSON;
• mapping information created or stored by the user;
• information generated from those mappings;
• USDM use-case data;
• intermediate study-processing information; and
• other study-specific or project-specific information created through the Platform.

Once this information has been removed, it may not be recoverable.

Your USDMPlay user account and the personal registration information associated with the account may remain available even after the study and project data have been removed.

Account information is handled in accordance with the USDMPlay Privacy Policy.

14. You Are Responsible for Keeping Your Own Copies

USDMPlay must not be treated as a backup or permanent repository.

You are responsible for retaining your own copies of:

• USDM JSON files;
• mappings;
• transformed outputs;
• generated files;
• study information; and
• any other information you wish to preserve.

USDMPlay is not responsible for restoring study or project information removed under the retention policy.

15. Ask USDM and Artificial Intelligence

USDMPlay includes AI-enabled functionality, including the Ask USDM AI chatbot.

The AI functionality is deliberately presented to the user as an AI feature. By selecting and interacting with the AI chatbot, you acknowledge that you are interacting with an artificial intelligence-enabled system.

The AI functionality may use natural-language processing, text-to-SQL techniques or other AI-assisted methods to interpret questions and retrieve or present information relating to your study design.

AI-generated or AI-assisted responses may:

• be incorrect;
• misunderstand the user’s question;
• retrieve incomplete information;
• misinterpret study relationships;
• omit relevant context;
• generate technically incorrect conclusions; or
• provide an answer that requires further professional interpretation.

AI responses are intended only to support learning and exploration.

They must not be regarded as authoritative interpretations of USDM, CDISC standards, clinical study design or regulatory requirements.

16. Human Review of AI Outputs

Users remain responsible for reviewing information generated or retrieved through AI functionality.

You should independently verify AI-assisted answers before using them for professional purposes.

AI outputs should not, without appropriate independent review, be used to make decisions concerning:

• patient treatment;
• participant safety;
• clinical trial eligibility;
• study conduct;
• regulatory strategy;
• regulatory submissions;
• statistical conclusions;
• production database design; or
• other activities where an incorrect answer could have significant consequences.

17. AI Prompts and Sensitive Information

The same data restrictions applicable elsewhere in USDMPlay also apply to the AI chatbot.

Do not enter confidential, personal, patient-level, production or otherwise restricted information into an AI prompt.

The presence of an AI interface does not change the permitted-data rules described in these Terms.

18. Downstream Automations and Transformations

USDMPlay may demonstrate how information represented in USDM could potentially support downstream applications or transformations such as:

• SDTM Trial Design Domains;
• Schedule of Activities;
• Patient Journey representations;
• ICH M11-related content;
• Define.xml-related content;
• protocol-related representations;
• study-design visualisations;
• metadata mapping;
• standards-related transformations; and
• other Digital Data Flow use cases.

These capabilities are educational demonstrations of automation concepts.

Generated or transformed outputs are not automatically:

• validated;
• compliant;
• complete;
• submission-ready;
• production-ready; or
• suitable for regulatory use.

Human review remains essential.

19. Responsibility for Generated Outputs

USDMPlay does not guarantee that generated output conforms to every rule, requirement, implementation guide, controlled terminology package, schema, regulatory expectation or organisation-specific convention.

Standards and implementation guidance may also change over time.

Before relying upon an output, users should review it against the applicable official standards, implementation guides, controlled terminology, validation rules and regulatory requirements.

The final decision to use any USDMPlay output outside the educational environment remains the responsibility of the user.

20. No Professional Advice

Information available through USDMPlay does not constitute:

• medical advice;
• clinical advice;
• regulatory advice;
• legal advice;
• statistical advice;
• compliance advice; or
• other professional advice.

Educational explanations, demonstrations and AI-generated responses should not replace appropriately qualified professional judgement.

21. Supported Standards and Versions

USDMPlay currently focuses on USDM Version 4.0.

Platform capabilities may support some portions or use cases of a standard more completely than others.

Support for a particular standard or version does not mean USDMPlay is an official, normative or complete implementation of that standard.

Standards evolve over time. Users should consult official sources for the current normative specifications.

22. Acceptable Use

You may use USDMPlay for legitimate educational, learning, demonstration and professional-exploration purposes.

You must not use the Platform to:

• violate applicable law;
• infringe another person’s rights;
• upload information you are not authorised to use;
• process prohibited clinical or personal information;
• distribute malware or harmful code;
• gain unauthorised access to another user’s account;
• attempt to bypass security controls;
• intentionally interfere with Platform operation;
• overload or disrupt Platform infrastructure;
• perform unauthorised penetration testing or vulnerability testing;
• exploit identified vulnerabilities;
• systematically scrape substantial Platform content;
• use automated systems in a way that creates unreasonable load;
• misrepresent USDMPlay outputs as official CDISC or regulatory outputs;
• falsely represent USDMPlay as endorsed by CDISC, TransCelerate or another organisation; or
• use the Platform for unlawful, abusive or fraudulent purposes.

23. Security Research

If you discover a potential security vulnerability, please do not exploit it or attempt to access information belonging to another user.

Please report suspected security issues responsibly through:

support@usdmplay.com

Good-faith reporting is welcomed.

24. Intellectual Property

Except for:

• user-uploaded content;
• third-party standards;
• third-party trademarks;
• third-party documentation; and
• other material owned by third parties,

the original USDMPlay software, user interface, educational material, explanatory content, graphics, application design and other original content are protected by applicable intellectual-property laws.

USDMPlay content may be used for reasonable personal, professional and educational learning purposes.

Unless permission has been granted, users may not:

• sell USDMPlay;
• resell access to USDMPlay;
• reproduce substantial portions of the application as a competing service;
• remove ownership or attribution notices;
• represent USDMPlay content as their own; or
• commercially redistribute proprietary USDMPlay software or content.

25. Third-Party Standards and Intellectual Property

USDMPlay refers to standards, specifications, terminology and materials developed or maintained by third parties.

Any intellectual-property rights belonging to CDISC, TransCelerate, ICH or other organisations remain the property of their respective owners.

USDMPlay does not claim ownership of third-party standards merely because those standards are discussed, demonstrated or represented through the Platform.

Users remain responsible for complying with applicable licences or usage conditions governing third-party materials.

26. Feedback and Community Contributions

USDMPlay encourages users to provide:

• bug reports;
• enhancement suggestions;
• usability feedback;
• educational suggestions; and
• general comments.

Feedback may be used to improve USDMPlay without an obligation to compensate the person providing it.

Providing feedback does not transfer ownership of your study data, confidential material or other unrelated intellectual property.

Do not include confidential or sensitive information in feedback submissions.

27. Platform Availability

USDMPlay is operated as a free educational and community initiative.

Although reasonable efforts may be made to keep the Platform available, continuous availability cannot be guaranteed.

USDMPlay may occasionally be unavailable because of:

• maintenance;
• software updates;
• infrastructure limitations;
• technical failures;
• security events;
• third-party-service interruptions; or
• other circumstances.

USDMPlay should therefore not be relied upon for business-critical, production or time-sensitive operations.

28. Changes to Features

USDMPlay is continuously evolving.

Functionality may be:

• introduced;
• modified;
• redesigned;
• temporarily disabled;
• replaced; or
• discontinued

as the Platform develops.

The existence of a feature at a particular time does not guarantee that it will remain permanently available.

29. Third-Party Services

USDMPlay may rely upon or interact with third-party infrastructure, APIs, libraries, cloud services, AI technologies or other technical services.

Where third parties process personal information on behalf of USDMPlay, relevant information will be described in the Privacy Policy where required.

USDMPlay may also contain links to external websites.

External websites operate under their own terms and privacy practices, and USDMPlay is not responsible for third-party content merely because a link appears on the Platform.

30. Privacy and Personal Data

Rajesh Saha acts as the data controller for personal information collected and processed by USDMPlay.

USDMPlay collects certain information necessary to create and operate user accounts and provide Platform functionality.

USDMPlay follows a data-minimisation approach and does not intentionally request patient-level or regulated clinical information.

The collection, purposes, lawful basis, retention, recipients and rights relating to personal data are explained separately in the USDMPlay Privacy Policy.

The Privacy Policy should be read together with these Terms.

31. Account Suspension

USDMPlay may suspend, restrict or terminate access where reasonably necessary, including where:

• these Terms are seriously or repeatedly violated;
• security is threatened;
• another user’s information may be at risk;
• the Platform is intentionally abused;
• unlawful activity is suspected; or
• continued access would create significant technical, security or legal risk.

Where reasonably possible and appropriate, the user may be informed of the reason for such action.

Nothing in this section affects rights that cannot legally be excluded.

32. Stopping Use of USDMPlay

You may stop using USDMPlay at any time.

You may also contact USDMPlay regarding deletion of your account or personal information in accordance with the Privacy Policy and applicable data-protection law.

Remember that study and project information may automatically be removed following 10 consecutive days without login.

33. Disclaimer of Warranties

To the maximum extent permitted by applicable law, USDMPlay is provided on an:

“AS IS” and “AS AVAILABLE” basis.

Because USDMPlay is an educational and demonstration environment, no guarantee is made that:

• the Platform will always be available;
• every feature will operate without error;
• every USDM object or relationship will be interpreted correctly;
• transformed outputs will be complete;
• mappings will be accurate;
• AI-generated information will be correct;
• data will always be recoverable;
• generated content will meet regulatory expectations;
• outputs will satisfy a particular organisation’s standards; or
• the Platform is appropriate for production use.

Nothing in these Terms excludes any warranty, right or protection that cannot lawfully be excluded under Belgian or European Union law.

34. Limitation of Liability

To the maximum extent permitted by applicable law, Rajesh Saha and persons contributing to the development or maintenance of USDMPlay will not be liable for indirect, incidental, consequential or special losses arising from use of or inability to use the Platform.

This may include loss or damage arising from:

• reliance upon incorrect AI-generated information;
• incorrect mappings;
• inaccurate transformations;
• incomplete outputs;
• deletion of study or project data under the retention policy;
• failure to maintain an independent copy of uploaded information;
• service interruption;
• inappropriate use of USDMPlay for production purposes;
• regulatory decisions based upon USDMPlay output; or
• a user’s unauthorised upload of confidential or restricted information.

Users remain responsible for evaluating whether information generated by USDMPlay is appropriate for their intended purpose.

Nothing in these Terms excludes or limits liability where doing so would be prohibited by applicable law, including liability that cannot legally be excluded for fraud, wilful misconduct, personal injury or other mandatory grounds.

35. User Responsibility

You are responsible for:

• the information you upload;
• ensuring you have authority to upload it;
• complying with employer and sponsor policies;
• independently verifying Platform outputs;
• determining whether generated information is appropriate for your intended use;
• maintaining copies of information you wish to preserve; and
• using the Platform consistently with these Terms.

36. Changes to These Terms

USDMPlay may update these Terms when necessary to reflect:

• new Platform functionality;
• changes in technology;
• security requirements;
• changes to operating practices; or
• legal or regulatory developments.

The current version and its Last Updated date will be made available through the USDMPlay website.

Where a change materially affects registered users’ rights or obligations, reasonable efforts may be made to provide additional notice.

Continued use of the Platform after revised Terms become effective constitutes acceptance of the revised Terms to the extent permitted by applicable law.

37. Governing Law

USDMPlay is primarily operated from Belgium.

These Terms are therefore governed by the laws of Belgium, together with directly applicable European Union law.

If you use USDMPlay as a consumer and mandatory laws applicable in your country of residence provide additional protections, nothing in these Terms is intended to deprive you of protections that cannot lawfully be waived or restricted.

38. Disputes

If a concern or dispute arises relating to USDMPlay, users are encouraged to contact:

support@usdmplay.com

so that an attempt can first be made to resolve the matter informally.

Where a dispute cannot be resolved, the competent Belgian courts will have jurisdiction to the extent permitted by applicable law and subject to any mandatory jurisdictional rights available to users under Belgian or European Union law.

39. Severability

If any provision of these Terms is determined to be invalid, unlawful or unenforceable, that provision will be interpreted or limited to the extent necessary to make it enforceable where possible.

The remaining provisions will continue to apply.

40. No Waiver

Failure to enforce a provision of these Terms does not mean that the right to enforce that provision has been waived.

41. Entire Terms

These Terms, together with the USDMPlay Privacy Policy and any additional notices expressly incorporated into them, govern the use of USDMPlay.

42. Contact

For questions, concerns, feedback or reports relating to these Terms or USDMPlay, contact:

USDMPlay
Owner & Operator: Rajesh Saha
Location: Belgium
Email: support@usdmplay.com

Important Reminder

USDMPlay is a free, independent educational and demonstration platform.

It is not affiliated with or endorsed by CDISC or TransCelerate.

It is not a validated or production-ready clinical system.

Upload only publicly available or non-production data. Never upload patient-level, confidential or regulated clinical data.

AI-generated answers, mappings, transformations and other outputs should always be independently reviewed before being used for professional work.