Terms of service

1. The service

Randomizer helps research teams randomize participants or sites to groups, track enrollment and let participants join studies. It's offered free of charge. Inclivio may change, add or remove features, limit use, or stop offering the service, in whole or in part, at any time and without notice.

2. Not for protected health information

Randomizer is not designed, operated or certified to meet the Health Insurance Portability and Accountability Act (HIPAA), its Privacy, Security and Breach Notification Rules, or any similar law about health information. Inclivio is not a covered entity or a business associate, and won't enter into a business associate agreement.

You agree not to put into the service:

• protected health information as HIPAA defines it;
• names, contact details, dates of birth, medical record numbers or other details that identify participants, beyond what the service needs to work;
• health, genetic, or biometric data, or any other special category of personal data, that could be linked to a participant.

Identify participants by study codes you assign, such as S-0042, and keep the key linking codes to people outside Randomizer. Record stratification factors as coded levels rather than detail about a person. If you enter data you agreed not to, you do so at your own risk, and you're solely responsible for the consequences.

3. Not validated for regulated use

Randomizer is not a medical device and gives no medical advice. It hasn't been validated against 21 CFR Part 11, Good Clinical Practice, or any other regulatory standard for electronic records or clinical trial systems. If your study needs a validated system, it's up to you to decide whether Randomizer is suitable, and to do any validation yourself.

4. Your account

• You must be at least 18 years old to create an account.
• Give accurate details when you sign up, and keep them up to date.
• Keep your password and API keys secret. You're responsible for everything done with your account or your keys. Tell us at support@inclivio.com if you think someone else has used them.
• If you use Randomizer for an organization, you confirm you're allowed to accept these terms for it.

5. Your responsibilities as a researcher

If you run a study with Randomizer, you're responsible for:

• getting any ethics or institutional review board approval, registration and informed consent your study needs, and having a lawful basis for any participant data you enter;
• choosing the randomization method and settings, and checking they suit your protocol. The randomization guide explains each method, but it's not a substitute for your statistician;
• checking allocations, and keeping your own independent record of every one. Don't rely on Randomizer as the only copy;
• who you add to a project, and what they can see and do there;
• answering participants who ask about their data. Inclivio will pass such requests to you where it can.

6. Your content

You keep ownership of what you put into Randomizer, such as projects, schemes and participant records. You give Inclivio a worldwide, non-exclusive, royalty-free license to store, copy, process and show it as needed to run the service for you and the people you share it with. You confirm you have the rights to give that license. The privacy notice explains how personal data is handled.

7. Acceptable use

You agree not to:

• break any law, or anyone else's rights, using the service;
• put protected health information or other prohibited data into it (section 2);
• try to get around its security, access controls or rate limits, or reach data or accounts that aren't yours;
• overload, disrupt or interfere with the service, or use it to send spam or malicious code;
• scrape it, or use automated means to reach it other than the documented API;
• resell the service, or pretend to be someone else using it.

8. Third-party services

Randomizer runs on Google Firebase and Google Cloud, and loads fonts from Google Fonts. Those services are outside Inclivio's control, and Inclivio isn't responsible for them, their availability or what they do.

9. Availability and data loss

There's no service level agreement. Randomizer may be slow, unavailable or interrupted, and data in it may be lost or corrupted, including allocations. Keep your own copies of anything you need, and plan for what your study will do if the service is unavailable when a participant needs to be randomized.

10. Ending your use

You may stop using Randomizer at any time, and ask us to delete your account by emailing support@inclivio.com. Inclivio may suspend or close your account, or delete its data, at any time, for any reason, including a breach of these terms. Sections 2, 3 and 6 to 15 continue to apply after your use ends.

11. No warranty

THE SERVICE IS PROVIDED FREE OF CHARGE, “AS IS” AND “AS AVAILABLE”, WITHOUT WARRANTIES OF ANY KIND, EXPRESS, IMPLIED OR STATUTORY. TO THE FULLEST EXTENT PERMITTED BY LAW, INCLIVIO DISCLAIMS ALL WARRANTIES, INCLUDING ANY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT AND ACCURACY. INCLIVIO DOES NOT WARRANT THAT THE SERVICE WILL BE UNINTERRUPTED, SECURE OR ERROR-FREE, THAT ALLOCATIONS OR OTHER RESULTS WILL BE CORRECT OR SUITABLE FOR YOUR STUDY, OR THAT ANY DATA WILL BE PRESERVED. YOU USE THE SERVICE AT YOUR OWN RISK.

12. No liability

TO THE FULLEST EXTENT PERMITTED BY LAW, INCLIVIO AND ITS OWNERS, EMPLOYEES, CONTRACTORS AND SUPPLIERS WILL NOT BE LIABLE TO YOU OR ANYONE ELSE FOR ANY DAMAGES OR LOSSES ARISING FROM OR RELATED TO THE SERVICE OR THESE TERMS, WHETHER DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY OR PUNITIVE, AND WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE, EVEN IF ADVISED OF THEIR POSSIBILITY. THIS INCLUDES LOST OR INCORRECT DATA OR ALLOCATIONS, COMPROMISED STUDIES OR RESULTS, REGULATORY ACTION, HARM TO PARTICIPANTS, LOST PROFITS OR FUNDING, AND THE COST OF REPLACEMENT SERVICES.

IF INCLIVIO IS FOUND LIABLE DESPITE THIS, ITS TOTAL LIABILITY FOR ALL CLAIMS WILL NOT EXCEED FIFTY US DOLLARS (US$50).

Some jurisdictions don't allow some of these exclusions or limits, so they apply to you only as far as the law allows.

13. Indemnity

You agree to defend, indemnify and hold harmless Inclivio and its owners, employees and contractors against any claims, losses, liabilities and expenses, including reasonable attorneys' fees, arising from your use of the service, your content, your studies, or your breach of these terms or of any law, including any data you entered in breach of section 2.

14. Governing law

These terms are governed by the laws of the State of Washington, USA, and applicable US federal law, without regard to conflict-of-laws rules. Any dispute arising from them or the service will be resolved only in the state or federal courts located in Washington, and you consent to those courts' jurisdiction.

15. General

• Inclivio may change these terms. The date at the top shows when they last changed. If a change is significant, we'll try to tell you, for example by email or in the app. Using the service after a change means you accept it.
• These terms, with the privacy notice and cookie policy, are the whole agreement between you and Inclivio about the service.
• If any part of them can't be enforced, the rest still applies. Not enforcing a part isn't a waiver of it.
• You may not transfer these terms without our consent. Inclivio may transfer them, for example as part of a sale or reorganization.

Contact

Questions about these terms? Email support@inclivio.com.