You have the right to request that we delete the Personal Data that we have collected from you. Cross-sectional Study. 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. You will be required to indicate your consent by checking the appropriate dialogue boxes after you view the video regarding informed consent and type “I AGREE” in the final dialogue box. Once this is no longer required, we will delete this data from our records. Other trial categories. Please take time to read the following information carefully. We cannot guarantee the complete security of any data you share with us, and except as expressly required by law, we are not responsible for the theft, destruction, loss or inadvertent disclosure of your information or content. You agree that you won’t disclose your Account password to anyone and you’ll notify us immediately of any unauthorized use of your Account. You must create an Account to be able to participate in the Study and use the Services. We also ask that you take as much time as you need before deciding to take part in this Study or not. 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? We may choose to only share grouped, NON-identifiable, anonymous information with valid clinical researchers to help defeat 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. Observational studies can also help inform probable cause and effect associations before randomised data are available, as randomised controlled trials often take years to complete. The arbitration will be administered by the American Arbitration Association (“AAA”) in accordance with the Commercial Arbitration Rules and the Supplementary Procedures for Consumer Related Disputes (the “AAA Rules”) then in effect, except as modified by this “Dispute Resolution” section. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study) We hope that you participate and thank you again for trying to do your part to help BEAT COVID. This is the Beat Covid LLC (the “Company”) Privacy Policy. SOME JURISDICTIONS DO NOT ALLOW THE DISCLAIMER OF CERTAIN IMPLIED WARRANTIES, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU. 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. 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. They don’t answer the main research question about how well a treatment works, for example. We may terminate your participation in the Study and access to and use of the Services, at our sole discretion, at any time and without notice to you. BEAT COVID Adaptive Clinical Trial. We will only use Personal Data provided in a Valid Request to verify you and complete your request. The specific pieces of Personal Data that we have collected about you. What information will you share? Observational studies can determine if there are associations between smoking and lung cancer, but instead of the investigator controlling who smokes or not, smoking status is observed. Take 5-10 minutes to answer a confidential health survey and help beat COVID-19/coronavirus. This Study aims to collect information on individuals who have either been diagnosed with SARS-CoV-2 (also known as novel coronavirus) that causes the human disease known as COVID-19, or have been exposed to someone who has been diagnosed with COVID-19, or healthy individuals who wish to provide their information to join the fight against COVID-19. Your responsibility to pay any AAA filing, administrative and arbitrator fees will be solely as set forth in the AAA Rules. Clinical Trials Versus Observational Studies Infographic Link to Resource: View the Clinical Trials Versus Observational Studies infographic. If you use the Services after any changes to the Privacy Policy have been posted, that means you agree to all of the changes. No. Any terms we use in this Policy without defining them have the definitions given to them in the Terms of Use. 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. They aim to find out things such as whether patients and doctors are happy to take part, and how long it might take to collect and analyse the information. They help to investigate relationships that are unable to be tested under randomised controlled experiments, can help provide insight and develop hypotheses on what subsequent randomised evidence is needed for future research, and can provide an understanding on how things work in clinical practice. Observational studies have several advantages over randomized, controlled trials, including lower cost, greater timeliness, and a broader range of patients.1 Concern about inherent bias in these studies, however, has limited their use in comparing treatments.2,3 Observational studies are used primarily to identify risk factors and prognostic indicators and in situations in which randomized, controlled trials would be impossible or unethical.4 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. Upon any termination, discontinuation or cancellation of Services or your Account, all provisions of these Terms which by their nature should survive will survive, including, without limitation, the provisions entitled “Agreement to Terms,” “Feedback,” “Content and Content Rights,” “General Prohibitions and Client’s Enforcement Rights,” “Links to Third Party Websites or Resources,” “Termination,” “Warranty Disclaimers,” “Indemnity,” “Limitation of Liability,” “Dispute Resolution” and “General Terms.”. 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. We provide these links only as a convenience and are not responsible for the content or services on or available from those websites or resources or links displayed on such sites. You’re responsible for all activities that occur under your Account, whether or not you know about them. These studies may focus on risk factors, natural history, variations in disease progression or in disease treatment. The Company may disclose any records, electronic communications, information, materials or other content of any kind: (a) if we believe in good faith that applicable law, regulation or legal process requires it; (b) if such disclosure is necessary or appropriate to operate this Site; or (c) to protect our rights or property or the rights or property of our users and business partners. In an observational study, the investigator does not alter the care that people receive, but simply records observations and analyzes data. We will not provide your Personal Data to third parties for such third parties’ direct marketing purposes. Coming Soon . A clinical trial tests (or tries out) an intervention -- a potential drug, medical device, activity, or procedure -- in people. Pilot studiesare small scale versions of the main study. 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. 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. If you have any questions about these Terms or the Services, please contact the Company at info@beatcovidtrial.com and (708) 620-4608, or mail us at BEAT COVID LLC, 6320 WEST 159TH STREET, SUITE A, Oak Forest, IL 60452. Cohort studies and case control studies are two types of observational studies. The Study is designed to collect information from you and others to better help us understand the progression of COVID-19 symptoms and possible factors that may or may not influence risks for hospitalization, disease improvement, disease worsening, and possibly death. Patient & Public Involvement: Get Involved, About the Patient & Public Involvement Group, Enhancing skills of trial teams we work with across the globe. Subject to the AAA Rules, the arbitrator will have the discretion to direct a reasonable exchange of information by the parties, consistent with the expedited nature of the arbitration. We do not sell your Personal Data as defined in Nevada Revised Statutes Chapter 603A. when you provide such information directly to us, and. Your personally identifiable information will always remain confidential and will never be sold. The independent variable may be beyond the control of the investigator for a variety of reasons: By using our Services, you agree to be bound by these Terms. This two-step authentication is used for your protection so that others may not access your Account. You acknowledge that the Services and Content are protected by copyright, trademark, and other laws of the United States and foreign countries. For example, if one wanted to conduct a hypothetical trial to determine if smoking caused lung cancer, individuals would be randomized to smoke or not smoke, and then followed up until death to subsequently determine the effect of smoking on lung cancer. Prospective, observational study to assess the performance of CAA measurement as a diagnostic tool for the detection of Schistosoma haematobium infections in pregnant women and their child in Lambaréné, Gabon: study protocol of the freeBILy clinical trial in Gabon 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 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. There is no payment to participants for joining. Notices to us regarding any alleged violation of these Terms or copyright infringement on this Site should be directed to the Company at support@beatcovidtrial.com. By way of example, we currently collect your phone number and email. THE EXCLUSIONS AND LIMITATIONS OF DAMAGES SET FORTH ABOVE ARE FUNDAMENTAL ELEMENTS OF THE BASIS OF THE BARGAIN BETWEEN THE COMPANY AND YOU. 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. If you have any questions, you may ask the study doctor for more information before deciding to participate by calling (708) 620-4608 or by emailing us at info@beatcovidtrial.com. 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). We make no warranty that the Services will meet your requirements or be available on an uninterrupted, secure, or error-free basis. when Personal Data about you is automatically collected in connection with your use of the Company Services. Please note that if you’ve opted not to receive legal notice emails from us (or you haven’t provided us with your email address), those legal notices will still govern your use of the Services, and you are still responsible for reading and understanding them. Remember that your use of our Services is at all times subject to the Terms of Service, which incorporates this Privacy Policy. What are observational studies and how do they differ from clinical trials? You and the Company agree that any dispute, claim or controversy arising out of or relating to these Terms or the breach, termination, enforcement, interpretation or validity thereof or the use of the Services or Content (collectively, “Disputes”) will be settled by binding arbitration, except that each party retains the right: (i) to bring an individual action in small claims court and (ii) to seek injunctive or other equitable relief in a court of competent jurisdiction to prevent the actual or threatened infringement, misappropriation or violation of a party’s copyrights, trademarks, trade secrets, patents or other intellectual property rights (the action described in the foregoing clause (ii), an “IP Protection Action”). CLINICAL TRIAL: Carefully and ethically-designed experiment, in which participating subjects are … Additionally, observational studies help researchers know what happens in real life situations. The BEATCOVID Observational Clinical Trial aims to better understand how to prevent the spread of COVID-19 in people and how to reduce hospitalization rates in people with COVID-19. Instead, the researchers observe participants or measure certain outcomes to determine health outcomes. There are two main types of clinical studies: clinical trials and observational … You have the right to request certain information about our collection and use of your Personal Data over the past 12 months. 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. Get updates, instructions, and warning from the CDC. To make these Terms easier to read, the Site and the virtual clinical study it supports are collectively called the “Services.”. Research Clinicians and Other Third Parties:The purpose of our Services is to understand, treat and prevent the spread of COVID-19. The categories of sources from which that Personal Data was collected. If we do so, we’ll let you know either by posting the modified Terms on the Site or through other communications. The Company collects and process of the following types of Personal Data from you: The Company collects personal identifiers from you and your device such as your name, email address, phone number, date of birth, a user name and password, IP address, device ID, and other (All of the foregoing, “Personal Identifiers.”). Clinical research is medical research involving people. Please see the “Exercising Your Rights” section below for instructions regarding how to exercise these rights. YOU MUST SIGNIFY YOUR CONSENT TO THESE TERMS TO CONTINUE AND PARTICIPATE IN THIS STUDY. The JUPITER Study does not provide any medical advice. Ability to use the internet and check email regularly. 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. When conducting research, it is important for a researcher to be able to gather data by examining various subjects and being able to job down the outcome. The exclusive jurisdiction and venue of any IP Protection Action will be the state and federal courts located in the state of Illinois and each of the parties hereto waives any objection to jurisdiction and venue in such courts. If you have questions relating to your treatment or condition, you should consult your personal physician or other health care provider. information is being submitted, e.g., interventional, observational. 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. Cookies are small pieces of data – usually text files – placed on your computer, tablet, phone, or similar device when you use that device to visit our Services. 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. Feasibility studiesare designed to see if it is possible to do the main study. When you use the beatcovidtrial.com website, use the Company’s Services or otherwise participate in the Study, the Company collects Personal Data about you: On our beatcovidtrial.com website, the Company may collect Personal Data through cookies and similar technologies such as pixel tags, web beacons, clear GIFs, and JavaScript (collectively, “Cookies”) to enable our servers to recognize your web browser and tell us how and when you visit and use our website, to analyze trends, learn about our user base and operate and improve our website. Randomised clinical trials vs. observational studies . If you have any other questions, please email us at info@beatcovidtrial.com. 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. Judgment on the arbitration award may be entered in any court having jurisdiction thereof. A party who desires to initiate arbitration must provide the other party with a written Demand for Arbitration as specified in the AAA Rules. Caroline A. Sabin Dept. What are characteristics of people that are at higher risk for hospitalization from COVID-19? In the last ones, patients are assigned to active or control group by chance - through randomization - in order to reduce errors or bias and to remark only the differences due to the treatment. We are unable today to set any particular time limit on the storage of your sensitive personal data, but we will keep it under regular review and ensure that it is not kept longer than is necessary. Consent to provide a HIPAA waiver of health information to share protected health information. These studies serve as a collection of data from standard practice. The categories of third parties with whom we have shared your Personal Data. Observational study A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Subject to the foregoing, these Terms will bind and inure to the benefit of the parties, their successors and permitted assigns. Learn More about the BEAT COVID Medical Advisory Board. You will also be asked to update and supplement your Personal Data, and we will send you reminder emails on a regular basis to do so. By rejecting any change, you are agreeing that you will arbitrate any Dispute between you and the Company in accordance with the provisions of this “Dispute Resolution” section as of the date you first accepted these Terms (or accepted any subsequent changes to these Terms). involves research using human volunteers (also called participants) that is intended to add to medical knowledge You agree not to do any of the following (the “Prohibited User Actions”): Although we’re not obligated to monitor access to or use of the Services or Content or to review or edit any Content, we have the right to do so for the purpose of operating the Services, to ensure compliance with these Terms, or to comply with applicable law or other legal requirements. 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. Observational studies and clinical trials are two different methods that researchers use to collect data and test theories. All rights reserved. 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. We will not charge you a fee for making a Valid Request unless your Valid Request(s) is excessive, repetitive, or manifestly unfounded. If it comes to our attention, we discover or we are notified of an allegation that this Site or user Content involves User Prohibited Actions, then the Company may, but have no obligation to, investigate the allegation and determine in Company’s sole discretion whether to remove or request the removal of the same from this Site. The Company does not share your Personal Identifiers with marketers and other advertisers for any purpose. DEFINITION: In an observational study, is were researchers study the health outcomes in groups of participants according to a research plan.Data is gathered based on observations (blood test, MRI’s, movement changes, etc). When we allow them access to your data, we do not permit them to use it for their own purposes. The JUPITER Study is completely free to join. The Company processes Personal Identifiers for the purposes of providing you the Services and developing, improving, promoting and running the Services and for the purpose of ensuring the accuracy of the responses. Explore the different aspects of clinical trials and take a closer look at how Incyte clinical … Aside from choosing between an observational trial and an interventional trial, potential participants should also consider the differences between inpatient and outpatient studies. The Federal Arbitration Act will govern the interpretation and enforcement of this Section. We seek to protect your Personal Data from unauthorized access, use and disclosure using appropriate physical, technical, organizational and administrative security measures based on the type of Personal Data and how we are processing that data. 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. Except as expressly set forth in these Terms, the exercise by either party of any of its remedies under these Terms will be without prejudice to its other remedies under these Terms or otherwise. After participants are enrolled, about 5-10 minutes. You may cancel your Account at any time by sending an email to us at info@beatcovidtrial.com or by calling our telephone number, (708) 620-4608. 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. 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. You are being considered for this study because you have stated that you are interested in helping stop the spread of COVID-19 and helping researchers better understand COVID-19 spread. What is the JUPITER Study and why should I participate? 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. If you don’t agree to be bound by the modified Terms, then you may not use the Services anymore. 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)). Except as provided in the preceding sentence, this “Dispute Resolution” section will survive any termination of these Terms. IF YOU HAVE ANY QUESTIONS OR CONCERNS REGARDING THE CONSENT BEING REQUESTED, YOU SHOULD NOT PARTICIPATE IN THE STUDY AND YOU MAY NOT USE THE SERVICES. Observational studies observe people in normal settings. On the contrary, observational studies do not require randomization: differences in outcomes are only observed after a particular therapy has been opted for. If this specific paragraph is held unenforceable, then the entirety of this “Dispute Resolution” section will be deemed void. Participants are asked questions about COVID-19 testing, exposure, what steps you have taken to stay healthy, medical history, medication/vitamins usage. There are two HD observational trials in Canada to choose from: Enroll-HD and HD Clarity. Will my personal information be sold? Prospective vs. Retrospective Studies Prospective. To advance scientific research into the links between various factors, including a patient's health and a patient’s response to infection by COVID-19. 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 the parties are unable to agree upon an arbitrator within seven (7) days of delivery of the Demand for Arbitration, then the AAA will appoint the arbitrator in accordance with the AAA Rules. We at BEAT COVID take your privacy seriously. Notwithstanding the provisions of the “Changes to Terms or Services” section above, if the Company changes this “Dispute Resolution” section after the date you first accepted these Terms (or accepted any subsequent changes to these Terms), you may reject any such change by sending us written notice (including by email to info@beatcovidtrial.com) within 30 days of the date such change became effective, as indicated in the “Last Updated” date above or in the date of the Company’s email to you notifying you of such change. , observational studies and clinical trials, without such consent, will be deemed the date on which notice. These rights inpatient and outpatient studies and foreign countries and enforcement of this section a presentation... Terms or conduct that affects the Services will meet your requirements or be available on an outcome to the. The spread of COVID-19, will be asked to consent to these Terms without restriction please refer to our and... 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