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Last Updated: May 30, 2020
Pharmaceutical Research Associates, Inc. (“PRA,” “we,” “us,” “our”) owns and provides mobile and web- based enrollment, data collection, and engagement solutions for clinical research via this Mobile Health Platform powered by PRA’s Clinical6® software (the “App”).
PRA is making this App available on behalf of and at the direction of the pharmaceutical company (the “Sponsor”) sponsoring the clinical study in which you are participating (the “Study”). If you are a Study subject or their Care Circle member and are not sure who the Sponsor of the Study is, you can find out by speaking with your Study doctor or designated point of contact.
Purpose of the App
The App’s purpose to provide you with a mobile or web-based interface to complete Study-related tasks during your involvement in the Study. Your use of the App is limited only to Study-related tasks pre- configured for your use.
Your use of this App may be a pre-condition of your ability to participate in the study. If you are a Study subject or their Care Circle member, you may contact your Study doctor or designated point of contact if you have questions about your use of the App as part of the Study. If you are a Study doctor, site personnel, or other user, you may speak with your designated Study point of contact at PRA regarding your use of the App as part of the Study.
Collection and Use of Data
As described in the Clinical6® Mobile Health Platform Privacy Statement (the “Privacy Statement”), you will be required to provide certain personal information through the App that the Sponsor has determined is necessary to facilitate your participation in the Study. If you have questions about the use or disclosure of personal information collected through the App, you may contact the Sponsor or your Study doctor.
By using the App, you acknowledge and agree that:
1. Your personal information may be collected, used, and disclosed in accordance with the Privacy Statement; and
2. in addition to personal information collected through the App, the App may collect or generate anonymous, de-identified, or aggregated data relating to your use of the App that cannot reasonably be associated with or used to identify you, and that PRA may use and disclose that data for any lawful purpose, including but not limited to performance optimization, software updates, product support, future software development, and other services related to the App or the Study.
Restricted Use of App
You are not permitted to use the App to do any of the following: (1) duplicate, reverse engineer, decompile, disassemble, translate, derive code, or create a competing product; (2) extract, gather, or use information or other content available through the Software through any means not intentionally made available or provided for through the Software; (3) use any bots, spiders, trojans, worms, spyware, ransomware, bombs, viruses, denial-of-service attacks, or any other malicious code, device, or process; (4) attempt to circumvent or overcome any technological protection measures intended to restrict access to any portion of the Software; (5) disable, overburden, damage, or impair the Software or otherwise limit others’ use of the Software; (6) establish any link to the Software to or from another location or connect any user account to another application, website, system, or network; (7) sub- license, distribute, or use the Software or its content for the benefit of a third party; (8) access or attempt to access any other user’s accounts or restricted information or impersonate others; (9) remove any copyright, trademark, patent or other proprietary notices from the Software or its content or outputs; (10) harass, threaten, or use abusive language; (11) publish any libelous, defamatory, obscene, abusive, illegal, or otherwise reasonably objectionable statements; (12) disseminate advertisements, promotional materials, spam, junk mail, pyramid schemes or other forms of solicitation; or (13) engage in any other illegal conduct or conduct that otherwise exposes PRA or its affiliates to liability.
The App does not provide medical advice nor is it a medical device. If you are a Study subject or their Care Circle member, please consult with your Study doctor or primary care provider with any questions or concerns you may have regarding your individual needs or medical conditions or any related questions about your involvement in the Study.
Proprietary Rights and Restrictions
The content of the App including without limitation all images, designs, layouts, marks, trade names, and information posted on the App (collectively “Content”) are the property of PRA, Sponsor, or their licensors. Your use of the App does not provide you with any rights, ownership, or license to use the Content outside of the App. You are not permitted to copy, reproduce, display, distribute, transmit, resell, broadcast, reverse-engineer, create derivative works, or otherwise exploit Content in any manner without the prior written permission of PRA. You are not permitted to modify, change, delete, or disguise any proprietary or distinguishing notices or markings from the App or Content. We reserve all available legal remedies against you for infringement, misappropriation, or other unauthorized use or modification of Content.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE APP AND CONTENT ARE PROVIDED ON "AS IS" AND “AS AVAILABLE” BASIS WITHOUT ANY WARRANTY OF ANY KIND, WHETHER EXPRESS OR IMPLIED. WE DO NOT WARRANT THE APP OR CONTENT’S ACCURACY, RELIABILITY, OR QUALITY. WE DO NOT WARRANT ANY COMPATIBILITY WITH ANY BROWSER, INTERNET SERVICE, OR DEVICE. YOU ARE RESPONSIBLE FOR ANY DAMAGE TO YOUR SERVICE, SYSTEM, OR DEVICE THAT RESULTS FROM YOUR DOWNLOAD OR USE OF THE APP AND CONTENT.
Limitation of Liability
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, PRA TOGETHER WITH ITS AFFILIATES AND LICENSORS, AND SPONSOR ARE NOT LIABLE TO YOU IN ANY WAY (INCLUDING WITHOUT LIMITATION ANY DAMAGES SUFFERED) FOR YOUR USE OR INABILITY TO USE THE APP OR CONTENT OR ANY OTHER MATTER RELATING TO THE APP OR CONTENT.
Arbitration and Class-Action Waiver
To the maximum extent permitted by law, you agree to binding arbitration for the resolution of any claims or disputes related to your individual use of the App and waive your right to a trial. To the maximum extent permitted by law, you waive your right to join any class or representative action related to your use of the App against PRA, together with its affiliates and licensors, and Sponsor. You or PRA may exercise the right to arbitrate by providing the other party with written notice of any and all claims in sufficient detail to describe the substance of such claims. Any statute of limitations which would otherwise apply in a court or other proceedings will apply to any claims submitted for arbitration. Unless otherwise agreed between you and PRA, the arbitration will be conducted in a location where either party resides and be conducted by a neutral arbitrator in accordance with American Arbitration Association rules and U.S. Federal Rules of Evidence and Procedure.
Governing Law and Venue
Changes and Duration of Agreement
If you have created an account and would like to update the contact information you have provided to us, you must contact your Study doctor or designated contact (for Study subjects or their Care Circle members) or your designated Study point of contact at PRA (for Study doctors, site personnel, or other users) to do so. All notices to you relating to the App will be posted on the App or sent to you at the email address you provided.
For technical issues related to the App, please contact your Study doctor or designated contact (for Study subjects or their Care Circle members) or your study technical help desk at PRA (for Study doctors, site personnel, or other users).
For clinical issues related to the Study, please contact your Study doctor or designated contact (for Study subjects or their Care Circle members) or your study clinical representative at PRA (for Study doctors, site personnel, or other users).
Pharmaceutical Research Associates, Inc., 4130 ParkLake Avenue, Suite 400, Raleigh, North Carolina, 27612 USA, Attn: Vice President of Legal Affairs.