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28.12.2020

observational clinical trial

What is the JUPITER Study and why should I participate? For purposes of these Terms: (i) “Content” means text, graphics, images, music, software, audio, video, works of authorship of any kind, and information or other materials that are posted, generated, provided or otherwise made available through the Services; and (ii) “User Content” means any Personal Data or other Content that Account holders (including you) provide to be made available through the Services. The categories of Personal Data that we have collected about you. The arbitrator may award declaratory or injunctive relief only in favor of the claimant and only to the extent necessary to provide relief warranted by the claimant’s individual claim. The waiver of any such right or provision will be effective only if in writing and signed by a duly authorized representative of the Company. Some of the questions that are being evaluated include: What are the characteristics of people that are exposed to COVID-19 who never get the disease? These studies may focus on risk factors, natural history, variations in disease progression or in disease treatment. However, if your claim for damages does not exceed $1,000, the Company will pay all such fees unless the arbitrator finds that either the substance of your claim or the relief sought in your Demand for Arbitration was frivolous or was brought for an improper purpose (as measured by the standards set forth in Federal Rule of Civil Procedure 11(b)). Next Section: How do you make sure a trial is safe? Although we work to protect the security of your account and other data that we hold in our records, please be aware that no method of transmitting data over the Internet or storing data is completely secure. You must create an Account to be able to participate in the Study and use the Services. Each request that meets both of these criteria will be considered a “Valid Request.” We may not respond to requests that do not meet these criteria. The Company also uses Personal Identifiers to request your feedback on the Services and we may conduct other surveys (which are of course voluntary) and to send you information regarding the Services. Capture and analysis of data for a population at a point in time. The arbitrator’s award of damages must be consistent with the terms of the “Limitation of Liability” section above as to the types and amounts of damages for which a party may be held liable. There are two main types of clinical studies: clinical trials and observational … Feasibility studiesare designed to see if it is possible to do the main study. Caroline A. Sabin Dept. Clinical trials are a vital part of our discovery process, enabling us to explore innovative ways to support patients, healthcare professionals, and the broader healthcare community. A prospective study watches for outcomes, such as the development of a disease, during the study period and relates this to other factors such as suspected risk or protection factor(s). You may submit a Valid Request by emailing us at: info@beatcovidtrial.com, We Will Not Discriminate Against You for Exercising Your Rights Under the CCPA. Further, unless both you and the Company otherwise agree in writing, the arbitrator may not consolidate more than one person's claims, and may not otherwise preside over any form of any class or representative proceeding. Observational studies are ones where researchers observe the effect of a risk factor, diagnostic test, treatment or other intervention without trying to change who is or isn’t exposed to it. Without limiting the foregoing, WE EXPLICITLY DISCLAIM ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, QUIET ENJOYMENT AND NON-INFRINGEMENT AND ANY WARRANTIES ARISING OUT OF COURSE OF DEALING OR USAGE OF TRADE. Ability to complete electronic informed consent process. The JUPITER Study will provide clinical researchers and scientists with a large data set to evaluate and identify trends in order to better understand COVID-19 and stop COVID-19 spread. Registration of observational studies is just one of many changes needed to increase confidence in observational research, but we believe it is the crucial next step. If you believe that a child under 18 may have provided us Personal Data, please contact us at info@beatcovidtrial.com. However, the Company does treat the collection of your personal data seriously and requests that you ready the Privacy Policy carefully and consent to the Company’s use of your personal data in the manner provided in this Privacy Policy. Does the JUPITER Study provide any medical advice? All rights reserved. Observational studies observe people in normal settings. People who have been exposed to COVID-19 but haven't gotten COVID-19, People that have fully recovered from COVID-19, People that have been able to stay out of the hospital even if they have COVID-19. In a nutrition-related experimental study (also known as a clinical trial or interventional study), researchers provide participants with a diet, nutrition education, or other kind of intervention and evaluate its effects. We will not provide your Personal Data to third parties for such third parties’ direct marketing purposes. The Company may freely assign or transfer these Terms without restriction. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, WE EXPLICITLY DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE SERVICES ON THE SITE, EXCEPT SOLELY AS SET FORTH IN THESE TERMS OF SERVICE. JUPITER is an IRB-approved research study that obtains health information from people to try to identify characteristics and trends that can help beat the COVID-19 / coronavirus pandemic. Your personally identifiable information will always remain confidential and will never be sold. User represents and warrants with respect to any user Content, ratings or comments regarding physicians or other providers is based on information obtained by user as a patient of such physician or provider. 3.2 - Controlled Clinical Trials Compared to Observational Studies. It is critical that you answer all of these questions truthfully and accurately. The Company exclusively owns all right, title and interest in and to the Services and the Content, including all associated intellectual property rights, to be used and shared only as set forth in the Privacy Policy. Subject to the foregoing, these Terms will bind and inure to the benefit of the parties, their successors and permitted assigns. For instance, a birth cohort includes all people born within a given time frame. If we learn we have collected Personal Data from a child under 18, we will delete that information as soon as possible. User acknowledges and agrees that the Company may remove or not permit the posting of any such Content, in its sole discretion. What information will you share? Patient & Public Involvement: Get Involved, About the Patient & Public Involvement Group, Enhancing skills of trial teams we work with across the globe. If we determine that your Valid Request warrants a fee, we will notify you of the fee and explain that decision before completing your request. A clinical trial tests (or tries out) an intervention -- a potential drug, medical device, activity, or procedure -- in people. You may not assign or transfer these Terms, by operation of law or otherwise, without the Company’s prior written consent. If you don’t agree to these Terms, you may not use the Services. Observational Studies (OSs) and Randomized Controlled Trials (RCTs) are the main types of studies used to evaluate treatments. If there are any conflicts between this section and any other provision of this Privacy Policy and you are a California resident, the portion that is more protective of Personal Data shall control to the extent of such conflict. MRC Clinical Trials Unit at UCL90 High HolbornLondonWC1V 6LJ, Regulatory information, Toolkits & Templates. Measurement of 25(OH)D. Observational studies typically measure blood 25(OH)D concentration as the exposure (independent) variable and trials have used 25(OH)D level to evaluate the success of the intervention with vitamin D supplementation. They are called observational studies because the investigator observes individuals without manipulation or intervention. You will also be asked to consent to our use of the information we collect to share with hospitals, physician-scientists, and clinicians to assist in our fight against the spread and severity of the Covid 19 disease. By way of example, we currently collect your phone number and email. Please take time to read the following information carefully. The Company does not share or disclose any Personal Identifiers with medical researchers, EXCEPT, that the Company may disclose information regarding your location to medical researchers, without any other Personal Identifiers. Health data and other protected classification characteristics: As part of the Services, you may choose to submit Personal Data about yourself, such as your sex at birth and how you identify today, your age, your height, weight and information about your health, pre-existing conditions and symptoms (including your body temperature), general health, any supplements taken and other conditions or factors that may or may not have a bearing on your ability to withstand the COVID-19 virus. If your claim exceeds $10,000, your right to a hearing will be determined by the AAA Rules. The arbitrator’s decision will include the essential findings and conclusions upon which the arbitrator based the award. The Company reserves the right to view, monitor and record user Content on this Site without notice to or permission from you. If your claim does not exceed $10,000, then the arbitration will be conducted solely on the basis of the documents that you and the Company submit to the arbitrator, unless you request a hearing or the arbitrator determines that a hearing is necessary. This Study is not for persons for which COVID-19 has advanced enough to require hospitalization or other treatment outside of the home. Please read the following to learn how we treat your personal information. The Prohibited User Actions are expressly prohibited under the User Agreement. While randomised clinical trials (RCT) are considered to provide the most robust evidence of the efficacy of therapeutic options, they are affected by well-recognised qualitative and quantitative limitations that may not reflect how the drug of interest will perform in real-life. The arbitrator will render an award within the time frame specified in the AAA Rules. The Services may contain links to third-party websites or resources. The Company reserves the right to change this Policy from time to time as well, but the Company will alert you to changes by placing a notice in the website, by sending you an email, and/or by some other means. The Company is not intended to be a covered entity under HIPAA because it is not a health care provider under HIPAA nor does the Company provide any medical advice. THE EXCLUSIONS AND LIMITATIONS OF DAMAGES SET FORTH ABOVE ARE FUNDAMENTAL ELEMENTS OF THE BASIS OF THE BARGAIN BETWEEN THE COMPANY AND YOU. The JUPITER Study does not provide any medical advice. (Also, we do not ask you for your name.). These processors may include: Amazon Web Services, Aptible, Google Cloud Platform, Google Analytics, Google G Suite, and others. A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. You are invited to take part in JUPITER, an observational, virtual research study (the “Study”) to collect medical information which will help doctors and researchers better understand COVID-19. After participants are enrolled, about 5-10 minutes. Your responses (the “Personal Data”) is designed to provide hospitals, physician-scientists and other clinicians and researchers information that could help them in determining trends regarding how the disease is transmitted, which persons are more vulnerable to contracting COVID-19 and how to prevent the disease from advancing in those who are diagnosed with COVID-19. It’s important that you review the modified Terms whenever we modify them because if you continue to use the Services after we have posted the modified Terms on the Site, you are indicating to us that you agree to be bound by the modified Terms. What questions should you ask before participating in a trial? By using or accessing the beatcovidtrial.com website and by participating in JUPITER, the BEAT COVID Observational Clinical Study (the “Study”) in any manner (together, the “Services”), you acknowledge that you accept the policies outlined in this Privacy Policy (the “Policy”), and you hereby consent that the Company will collect, use, and share your information as set forth in this Policy. Although randomised controlled trials are useful in determining causal relationships between treatment and outcome, there are often instances where randomised controlled trials are not appropriate, so observational studies are needed. Remember that your use of our Services is at all times subject to the Terms of Service, which incorporates this Privacy Policy. Encourage or enable any other individual to do any of the foregoing. Feel free to talk with your doctor, nurse, family, or friends before deciding. This document describes information to help you make an informed decision as to whether or not you want to take part in this research study and provide your consent to use of your personally identifiable health information. The BEAT COVID Leadership Team and Medical Advisory Board is composed of leading physician-scientists, clinical researchers and doctors with decades of clinical research experience. JUPITER is an IRB-Approved Clinical Research Study that aims to help stop COVID-19 by identifying characteristics of: If enough people join the JUPITER Study, we hope to share information that can help in the development of new treatment strategies to stop COVID-19. COVID-19 can progress to serious illness and even death. NEITHER THE COMPANY NOR ANY OTHER PARTY INVOLVED IN CREATING, PRODUCING, OR DELIVERING THE SERVICES OR CONTENT WILL BE LIABLE FOR ANY INCIDENTAL, SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS, LOSS OF DATA OR GOODWILL, SERVICE INTERRUPTION, COMPUTER DAMAGE OR SYSTEM FAILURE OR THE COST OF SUBSTITUTE SERVICES ARISING OUT OF OR IN CONNECTION WITH THESE TERMS OR FROM THE USE OF OR INABILITY TO USE THE SERVICES OR CONTENT, WHETHER BASED ON WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE), PRODUCT LIABILITY OR ANY OTHER LEGAL THEORY, AND WHETHER OR NOT THE COMPANY HAS BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGE, EVEN IF A LIMITED REMEDY SET FORTH HEREIN IS FOUND TO HAVE FAILED OF ITS ESSENTIAL PURPOSE. Unless you and the Company otherwise agree, the arbitration will be conducted in the county where you reside. Read about the Coroavirus outbreak according to the WHO. The Study requests that you provide personally identifiable health information and other information relating to your diagnosis, care and treatment related to COVID-19 as well as other information you provide to the Company during the Study (the “Personal Data”). There are two types, observational studies and clinical trials. Any notices or other communications provided by the Company under these Terms, including those regarding modifications to these Terms, will be given by the Company: (i) via email to the email address you provide us via the Services; or (ii) by posting to the Site. The Company processes Personal Identifiers and Personal Data for the following purposes: As noted in the Terms of Use, we do not knowingly collect or solicit Personal Data from children under 18; if you are a child under 18, please do not attempt to register for or otherwise use the Services or send us any Personal Data. These Terms and any action related thereto will be governed by the laws of the State of Illinois without regard to its conflict of laws provisions. You agree not to remove, alter or obscure any copyright, trademark, service mark or other proprietary rights notices incorporated in or accompanying the Services or Content. If you have any questions about this section or whether any of the following applies to you, please contact us at info@beatcovidtrial.com.

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