日本語版こちらをクリック Privacy Policy Updated May 11, 2023 Purpose Signant Health is committed to transparency when it comes to its collection and use of Personal Data. This notice sets out Signant Health’s commitment to privacy, data protection, and individual rights and obligations in relation to Personal Data. This notice applies to all Personal Data of clients, clinical trial participants, vendors, job applicants, employees, contractors, former employees, and visitors to Signant Health’s website (such as cookies and internet tags) which is provided to, or collected and processed by Signant Health. If you are a resident of certain states in the United States, this Policy also incorporates our Supplemental Privacy Notice for US Residents, which includes additional information required to be provided under certain state laws. Signant Health respects individual privacy and values the confidence of its customers, employees, clinical trial participants, consumers, business partners and others. Signant Health strives to collect, use and disclose Personal Data in a manner consistent with the laws of the countries in which it does business, but it also has a tradition of upholding the highest ethical standards in its business practices. Signant Health’s Data Protection Officer is Rich Ngo and his role is to inform and advise Signant Health on its data protection obligations. The Data Protection Officer can be contacted at rich.ngo@signanthealth.com. Questions about this notice, or requests for further information, should be directed to the Data Protection Officer. Signant Health is compliant with the GDPR. This notice may occasionally be updated. When material updates are made, the date of the last revision will be reflected at the end of the page. Definitions “Signant Health” is the trademark name for a group of companies, including, but not limited to Bracket Global LLC, CRF Inc., Motentia, LLC, CRF Health Management Limited, VirTrial, LLC and any affiliates, successors, and subsidiaries, each as applicable. “Data Controller” is a natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the Processing of Personal Data. “Data Subject” is an identified or identifiable natural living person. “GDPR” is the European Union’s General Data Protection Regulation “Personal Data” is any information that relates to a living individual who can be identified from that information. Under GDPR this data is known as “Personally Identifiable Information”. “Processing” is any use that is made of data, including collecting, storing, amending, disclosing or destroying it. “Data Processor” is a natural or legal person, public authority, agency or other body which processes Personal Data on behalf of the data controller. “Special Categories of Personal Data” means information about an individual’s racial or ethnic origin, Criminal Records Data, political opinions, religious or philosophical beliefs, trade union membership, health, sex life or sexual orientation and biometric data, and is a form of Personal Data. “Criminal Records Data” means information about an individual’s criminal convictions and offences, and information relating to criminal allegations and proceedings. Data Protection Principles Signant Health processes Personal Data in accordance with the following data protection principles: Processes Personal Data fairly, lawfully, and in a transparent manner. Collect Personal Data only for specified, explicit and legitimate purposes. Process Personal Data only where it is adequate, relevant and limited to what is necessary for the purposes of Processing. Keep accurate Personal Data and takes all reasonable steps to ensure that inaccurate Personal Data is rectified or deleted without delay. Keep Personal Data only for the period necessary for Processing. Adopt appropriate measures to make sure that Personal Data is secure, and protected against unauthorized or unlawful Processing, and accidental loss, destruction or damage. Signant Health takes responsibility for how it acquires, processes, and disposes of Personal Data, and for ensuring compliance with the above principles. Where considered the Data Controller, Signant Health tells individuals the reasons for Processing their Personal Data, how it uses such data and the legal basis for Processing in its privacy notices, not processing Personal Data of individuals for other reasons. Where Signant Health relies on its legitimate interests as the basis for Processing data, it will carry out an assessment to ensure that those interests are not overridden by the rights and freedoms of individuals. Signant Health will update Personal Data promptly if an individual advises that his/her information has changed or is inaccurate. Personal Data gathered during employee and contractor relationships is held in the individual’s personnel file, in hard copy or electronic format and on Signant Health HR systems. The periods for which Signant Health holds such HR-related Personal Data are contained in its privacy notices issued to individuals. When Signant Health provides services to a sponsor of a clinical trial or Contract Research Organization (CRO), Signant Health is a Data Processor (or sub-processor), the CRO is a Data Processor and sponsor is the Data Controller. Where Signant Health is considered the Data Processor or sub-processor, Signant Health (a) will only process the Personal Data in accordance with the applicable laws, rules, regulations, and as specifically directed by the data controller; (b) and will use the Personal Data only to the extent necessary to provide the services. Depending on which service Signant Health provides to a Data Controller, Signant Health may collect the following categories of personal data: From site personnel: name, contact information, job title, work address, education, certifications, work experience, video or audio image, username, password, account logs; From sponsor/CRO personnel: name, contact information, job title, work address, username, password, account logs; From study subjects: study subject ID, initials, name, signature, email address, phone number, date of birth, health information, gender, video or audio image, username, password, account logs, device ID, if the device was provided by Signant Health. Some of our applications, e.g. the TrialMax application, may also collect location data to enable Bluetooth connections to study devices. The device manufacturers or the OS providers have no access to any Personal Data. How We Share Personal Data We may share Personal Data with the following categories of third parties to accomplish the purposes set out above and for the additional purposes set forth below. Signant Health group of companies and affiliated companies. We may share Personal Data with our group of companies and affiliated companies. Our Service Providers. We may share Personal Data with our vendors, consultants, and other service providers who we engage to perform services on our behalf, and who are not allowed to use Personal Data they receive from us for any other purpose. To Protect Our Legal Rights or Comply with Legal Requirements. We may disclose Personal Data as required by law, such as to comply with a subpoena or other legal process, when we believe in good faith that disclosure is necessary to protect our rights, protect your safety or the safety of others, investigate fraud, or respond to a government request. Sale or Transfer of Corporate Assets. In the event of a merger, sale, joint venture or other transaction involving a transfer of our business or assets, we may transfer your information to other parties involved in the transaction. Any entity acquiring our data assets will do so with the express, written commitment to use the data only for authorized purposes, and to maintain a similar level of privacy and information security protection. You will be notified via email or notice on our website of any change in ownership or uses of your personal information, as well as any choices you may have regarding your personal information. With Your Consent. We may disclose your personal information to other third parties with your prior opt-in consent. Signant Health keeps a record of its Personal Data Processing activities in accordance with the requirements of the GDPR. Individual Rights As a data subject, individuals have a number of rights in relation to their Personal Data. Subject Access Requests Individuals have the right to know what Personal Data about them is being controlled and processed by Signant Health and to ensure that such Personal Data is accurate and relevant for the purposes for which Signant Health collected it. If an individual makes a reasonable request, Signant Health will tell him/her: whether or not his/her data is processed and if so why, the categories of Personal Data concerned and the source of the data if it is not collected from the individual; to whom his/her data is or may be disclosed, including to recipients located outside the European Economic Area (EEA) and the safeguards that apply to such transfers; for how long his/her Personal Data is stored (or how that period is decided); his/her rights to rectification or erasure of data, or to restrict or object to Processing; his/her right to complain to the relevant data privacy supervisory authority if he/she thinks Signant Health has failed to comply with his/her data protection rights; and whether or not Signant Health carries out automated decision-making and the logic involved in any such decision-making. Signant Health will also provide the individual with a copy of the Personal Data that has been collected during Processing. This will normally be in electronic form if the individual has made a request electronically, unless the individual requests otherwise. If the individual requires additional copies, Signant Health may charge a reasonable fee, which will be based on the administrative costs of providing the additional copies. To make a subject access request, the individual should use Signant Health’s contact page https://signanthealth.com/contact-us/ or direct email to rich.ngo@signanthealth.com. In almost all cases, Signant Health is legally required to ask for proof of identification before the request can be processed. Also, in some cases, Signant Health may need to contact the data controller if Signant Health is the Data Processor (or sub-processor), if applicable. Signant Health will normally respond to a request within a period of one month from the date it is received. In some cases, such as where Signant Health processes large amounts of the individual’s data, it may respond within three months of the date the request is received. Signant Health will write to the individual within one month of receiving the original request to tell him/her if this is the case. If a subject access request is manifestly unfounded or excessive, Signant Health is not obliged to comply with it. Alternatively, Signant Health can agree to respond but will charge a fee, which will be based on the administrative cost of responding to the request. An example of when a subject access request is likely to be considered manifestly unfounded or excessive is where a request is repeated for which Signant Health has already responded. If an individual submits a request that is unfounded or excessive, Signant Health will notify him/her that this is the case and whether or not it will respond to it. Other Rights Individuals have a number of other rights in relation to their Personal Data. Individuals can require Signant Health to: inform them about the collection and use of their Personal Data; rectify inaccurate Personal Data; stop Processing or erase Personal Data that is no longer necessary for the purposes of Processing; continue to store their Personal Data but not use it; respect an individual’s right to object to the Processing of their Personal Data in certain circumstances such as for direct marketing; provide them with their Personal Data in a portable form, so that it can be easily transferred to another IT environment. We would usually fulfil this request by providing the data in the form of a “comma-separated-values” (csv) file; respect an individual’s rights related to automated decision making based on their Personal Data; stop Processing or erase Personal Data if the individual’s interests override Signant Health’s legitimate grounds for Processing Personal Data (where Signant Health relies on its legitimate interests as a reason for Processing Personal Data); stop Processing or erase Personal Data if Processing is unlawful; and stop Processing Personal Data for a period if data is inaccurate or if there is a dispute about whether or not the individual’s interests override Signant Health’s legitimate grounds for Processing Personal Data. To ask Signant Health to take any of these steps, the individual should use Signant Health’s contact page https://signanthealth.com/contact-us/, direct email to rich.ngo@signanthealth.com, or contact a Signant Health HR representative, or the data privacy officer, as the case may be. EU Persons (EU Data Subjects) may complain to their home data protection authority and can invoke binding arbitration for some residual claims not resolved by other redress mechanisms. If you have a comment or concern that cannot be resolved with us directly, you may also contact the competent local data protection authority. Data Security Signant Health takes the security of Personal Data seriously. Signant Health has internal policies and controls in place to protect Personal Data against loss, accidental destruction, misuse or disclosure, and to ensure that data is not accessed, except by employees in the proper performance of their duties. Where Signant Health engages third parties to process Personal Data on its behalf, such parties do so on the basis of written instructions, are under a duty of confidentiality and are obliged to implement appropriate technical and organizational measures to ensure the security of data. Signant Health recognizes potential liability in cases where Personal Data may be transferred to third parties. Signant Health will not transfer any Personal Data to a third party without first ensuring that the third-party adheres to principles or similar laws providing an adequate and equivalent level of protection. Signant Health does not transfer Personal Data to unrelated third parties, unless lawfully directed by a client or another data controller. For example, such circumstances would include disclosures of a client’s Personal Data required by law or legal process, or disclosures made in the vital interest of an identifiable person such as those involving life, health or safety. In the event that Signant Health is requested to transfer Personal Data to an unrelated third party, Signant Health will ensure that such party provides an adequate and equivalent level of protection. Should Signant Health learn that an unrelated third party which received Personal Data from Signant Health is using or disclosing Personal Data in a manner contrary to this notice, Signant Health will take reasonable steps to prevent or stop the use or disclosure. Impact Assessments Some of the Processing that Signant Health carries out may result in risks to privacy. Where Processing would result in a high risk to individual’s rights and freedoms, Signant Health will carry out a data protection impact assessment to determine the necessity and proportionality of Processing. This will include considering the purposes for which the activity is carried out, the risks for individuals and the measures that can be put in place to mitigate those risks. Data Breaches If Signant Health discovers that there has been a breach of Personal Data that poses a risk to the rights and freedoms of individuals, it will report it to the Information Commissioner within 72 hours of discovery. Signant Health will record all data breaches regardless of their effect. If the breach is likely to result in a high risk to the rights and freedoms of individuals, it will tell affected individuals that there has been a breach and provide them with information about its likely consequences and the mitigation measures it has taken. International Data Transfers Personal Data controlled or processed by Signant Health may be transferred to countries outside the EEA. Signant Health assures compliance with this notice by utilizing Standard Contractual Clauses, applicable, and fully investigating and attempting to resolve any complaint or dispute regarding the use and disclosure of Personal Data in violation of this notice. EU individuals with inquiries or complaints regarding our Privacy Policy should first contact Signant Health at: Rich NgoData Protection Officer785 Arbor Way Blue Bell, PA 19422 Phone: 267 422 1700Email: rich.ngo@signanthealth.com Signant Health Employee Responsibilities Signant Health employees may have access to the Personal Data of other individuals and of our customers and clients in the course of their employment. Where this is the case, Signant Health relies on individuals to help meet its data protection obligations to staff and to customers and clients. Employees who have access to Personal Data are required: to access only data that they have authority to access and only for authorized purposes; not to disclose data except to individuals whether inside or outside Signant Health who have appropriate authorization; to keep data secure for example by complying with rules on access to premises, computer access, including password protection, and secure file storage and destruction; not to remove Personal Data, or devices containing or that can be used to access Personal Data, from Signant Health premises without adopting appropriate security measures such as encryption or password protection to secure the data and the device; not to store Personal Data on local drives or on personal devices that are used for work purposes; and to report data breaches of which they become aware to Rich Ngo, rich.ngo@signanthealth.com the data protection officer immediately. Failing to observe these requirements may amount to a disciplinary offence, which will be dealt with under Signant Health’s disciplinary policies and procedures. Signant Health will provide training to all employees about their data protection responsibilities as part of the induction process and at regular intervals thereafter. Employees whose roles require regular access to Personal Data, or who are responsible for implementing this notice or responding to subject access requests under this notice, will receive additional training to help them understand their duties and how to comply with them. Internet Privacy Signant Health, or third parties at the direction of Signant Health, may collect Personal Data through its website and visitors’ interactions with elements of its website, which are also subject to this notice. Such Personal Data can be collected when an individual submits his or her name and/or address. Signant Health, or third parties at the direction of Signant Health, can also collect information about visits to the Signant Health website without an individual actively submitting information through various automated digital means, such as IP addresses, cookie identifiers, pixels, and end-user website activity. Although the information collected by such automated digital means does not directly identify specific individuals, internet web browsers automatically transmit information to the Signant Health website regarding the software a user’s computer is operating, such as IP address and browser version. Information collected by these technologies cannot be used to identify individuals without additional identifiable information. Cookies Signant Health uses cookies which are small data files that are served by our platform and stored on your device. 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