Preface
Intended Use
SliceVault is intended to be used by trained professionals to facilitate the management of imaging data in clinical trials. It is designed to:
- Transfer, store, manage, and share medical imaging data securely.
- Be used in clinical trials where the sponsor or responsible party ensures compliance with applicable laws, regulations, ICH guidelines for Good Clinical Practice, the Declaration of Helsinki, and study protocols.
- Support trials that have received the necessary approvals from regulatory authorities, ethics committees, or other relevant bodies.
Disclaimer
SliceVault is a cloud-based service (the “platform” or “SliceVault”) designed to transfer, store, manage, and share medical imaging data in clinical trials. Please note:
- No part of the platform is categorized as a medical device by the FDA or EMA.
- SliceVault includes automated systems for de-identification of medical imaging data. However, the responsibility for ensuring proper de-identification remains with the user importing data.
- SliceVault does not guarantee the accuracy or completeness of data processed through its services.
Symbols and Definitions
Below are the symbols used in this manual:
| Symbol | Occurrence | Meaning |
|---|---|---|
| ⚠️ | In the user manual | Warning/Caution, always clarified with details. |
Software Errors and Warnings
Occasionally, unforeseen software errors or warnings may appear in your browser while using SliceVault. To help improve future versions, please report any errors by visiting our Support Page, where you’ll find guidance on who to contact based on your role.
Your feedback is essential in ensuring the quality and reliability of our platform.