Meditrial EDC System Privacy Statement
Meditrial Europe LTD, headquartered in Zug, Bahnhofstrasse 23, CH-6300, Switzerland, (henceforth “Meditrial”) is committed to protecting your privacy and developing technology that gives you the most powerful and safe online experience. This Statement of Privacy applies to Meditrial’s EDC Systems (collectively referred to as the “Services”) and governs data collection and usage. By using the Services, you consent to the data practices described in this statement.
Data Protection Officer
Principles relating to processing of personal data
According to the article 5 of GDPR any personal data which you provide to Meditrial over the Services or which is otherwise gathered via the website by Meditrial will be:
- processed lawfully, fairly and in a transparent manner in relation to the data subject (‘lawfulness, fairness and transparency’);
- collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes (‘purpose limitation’);
- adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed (‘data minimization’);
- accurate and, where necessary, kept up to date; every reasonable step must be taken to ensure that personal data that are inaccurate, having regard to the purposes for which they are processed, are erased or rectified without delay (‘accuracy’);
- kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed; (‘storage limitation’);
- processed in a manner that ensures appropriate security of the personal data, including protection against unauthorized or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organizational measures (‘integrity and confidentiality’).
Personal data processed
Name, address and contact details
Meditrial collects personally identifiable information (“personal data”), such as your e-mail address, name, home or work address or telephone number. Meditrial also collects anonymous demographic information, which is not unique to you, such as your ZIP code, age, gender, preferences, interests and favorites. To request information, a demo, a free trial, an account, or to sign up for the newsletter, you will be required to provide some personal data, by entering your information in the requested text fields. If you decide to fill those fields sharing personal data related to other persons, you will be considered as an independent data controller regarding that personal data and must assume all inherent legal obligations and responsibilities. This means, among other things, that you must fully indemnify Meditrial against any complaints, claims or demands for compensation for damages which may arise from the processing of this personal data, brought by the third parties whose information you provide through the Services.
There is also information about your computer hardware and software that is automatically collected by Meditrial. This information can include: your IP address, browser type, domain names, access times and referring website addresses. This information is used by Meditrial for the operation of the service, to maintain quality of the service, and to provide general statistics regarding use of the Services.
Special categories of personal data
Sensitive personal data is not requested information on the Services. Please be aware that if you provide personal data filling free text fields, you may inadvertently disclose more sensitive categories of personal data (e.g., but not limited to, data revealing your race or ethnic origin, political opinions, religious or philosophical beliefs or trade union membership).
Meditrial asks that you do not disclose any sensitive personal data on the Services, unless you consider this to be strictly necessary. As it is totally optional to provide this information, if you do, this action will be an explicit consent to process the personal data provided by you. Meditrial does not use or disclose sensitive personal information, such as race, religion, or political affiliations, without your explicit consent. Please keep also in mind that if you directly disclose personally identifiable information or personally sensitive data through Meditrial public message boards, you relieve Meditrial of any liability relating to the processing of this data, which may be collected and used by others.
d. Designer role
If you have the role as EDC Designer, then you will collect personally identifiable information (“personal data”) of the eCRF users, such as e-mail addresses, names, home or work addresses or telephone numbers. Also, you will have the privilege to create forms, eCRFs, upload and publish documents as well as provide access to other users. In this case, you will be considered as an independent data controller regarding any personal data, even on behalf of the users you activate, and you must assume all inherent legal obligations and responsibilities. This means, among other things, that you must fully indemnify Meditrial against any complaints, claims or demands for compensation for damages which may arise from the processing of this personal data, brought by the third parties whose information you provide through the services.
Purpose of processing
Meditrial intends to use your personal data, collected through the Services, for the following purposes:
Meditrial collects and uses your personal information to operate the Services and provide the deliverables you may request.
Meditrial also uses your personal data to inform you of other products or services available from Meditrial and its affiliates. Meditrial may also contact you via surveys to conduct research about your opinion of current services or of potential new services that may be offered.
The Services provide forms allowing visitors or users to submit search engine queries, questionnaires, feedback, or other information. Some of these forms may request personally identifiable information (e.g., name, address, phone number, e-mail address) for specific purposes, such as when the submitter is requesting a demo, a free trial, an account or signing up for the newsletter. All information submitted by visitors is voluntary.
Moreover, Meditrial keeps track of the websites and pages our customers visit within the Services, in order to determine what services are the most popular. This data is used to deliver customized content and advertising to customers whose behavior indicates that they are interested in a particular subject area.
Meditrial will process your personal data to maintain appropriate business records, to comply with lawful requests by public authorities and to comply with applicable laws and regulations or as otherwise required by law.
Your personal data may be handled by Meditrial to prevent and detect any misuse of the Services and any fraudulent activity carried out through them.
Data retention period
The data retention period varies according to the different purposes of processing. In detail personal data processed for:
- Service Provision will be kept by Meditrial for the period deemed strictly necessary to fulfill such purpose. In any case, as these personal data is processed for the provision of the services, Meditrial may continue to store this personal data for a longer period, as may be necessary to protect Meditrial’s interests related to potential liability related to the provision of the Services;
- Marketing and Profiling will be kept by Meditrial from the moment you give consent until the moment you withdraw the consent given. Once consent is withdrawn, personal data will no longer be used for these purposes, although it may still be kept by Meditrial, in particular as may be necessary to protect Meditrial’s interests related to potential liability related to this processing;
- Compliance will be kept by Meditrial for the period required by the specific legal obligation or by the applicable law;
- Preventing Misuse/Fraud will be kept by Meditrial for as long as deemed strictly necessary to fulfill these purposes.
Sharing of your personal data
The persons or entities with whom your personal data may be shared (“Recipients”) are listed below:
- Persons authoried by Meditrial to process personal data needed to carry out activities strictly related to the provision of the services, who have undertaken an obligation of confidentiality or are subject to an appropriate legal obligation of confidentiality (e.g., Meditrial personnel);
- Entities engaged in order to provide the services (e.g., hosting providers or e-mail platform providers);
- Persons, companies or professional firms providing Meditrial with advice and consultancy regarding accounting, administrative, legal, tax, financial and debt collection matters related to the provision of the services;
- Public entities, bodies or authorities to whom your personal data may be disclosed, in accordance with the applicable law or binding orders of those entities, bodies or authorities.
Meditrial will disclose your personal information, without notice, only if required to do so by law or in the good faith belief that such action is necessary to:
- protect and defend the rights or property of Meditrial;
- act under exigent circumstances to protect the personal safety of users of Meditrial, or the public.
Transfer of personal data
Meditrial EDC System users’ rights
With regard to the processing of your personal data, Meditrial acknowledges the following rights to you:
- the right to request access to and rectification or erasure of personal data or restriction of processing;
- the right to object to processing;
- the right to data portability;
- the right to withdraw their consent to data processing at any time, without affecting the lawfulness of processing based on consent before its withdrawal;
- the right to lodge a complaint with a Supervisory Authority in particular in the EU Member State of their habitual residence, place of work or place of the alleged infringement, if they consider that the processing of personal data relating to them infringes the GDPR.
You can always exercise your rights described above by sending a written request to Meditrial at the following address: email@example.com.
Misuse of Meditrial EDC System (disclosure of other’s personal data)
You are required to store only anonymized files in the EDC system. If you intentionally or inadvertently upload documents or images including personal data belonging to clinical trial patients or to other subjects, you will be considered as an independent Data Controller regarding that personal data and must assume all inherent legal obligations and responsibilities. This means, among other things, that you must fully indemnify Meditrial against any complaints, claims or demands for compensation for damages which may arise from the processing of this personal data, brought by the third parties whose information you provide through Meditrial EDC system. The same applies in the case you fill in the free text fields of the Case Report Forms with other’s personal data.
Security of your personal information
Meditrial secures your personal information from unauthorized access, use or disclosure. Meditrial secures the personally identifiable information you provide on computer servers in a controlled, secure environment, protected from unauthorized access, use or disclosure. Moreover, technical measures have been developed by Meditrial in order to ensure the anonymization of the data uploaded to Meditrial EDC system by users. For an in-depth analysis of all the data security measures, please read Meditrial EDC Systems Security Statements:
- Catchtrial: https://www.catchtrial.com/en/privacy-statement/
- Fastrial: https://www.fastrial.com/security-statement/
The Services use “cookies” to help you personalize your online experience. A cookie is a text file that is placed on your hard disk by a web page server. Cookies cannot be used to run programs or deliver viruses to your computer. Cookies are uniquely assigned to you, and can only be read by a web server in the domain that issued the cookie to you. One of the primary purposes of cookies is to provide a convenience feature to save you time. The purpose of a cookie is to tell the web server that you have returned to a specific page. For example, if you personalize the Services pages, or register on them, a cookie helps Meditrial to recall your specific information on subsequent visits. This simplifies the process of recording your personal information, such as billing addresses, shipping addresses, and so on. When you return to the same Services, the information you previously provided can be retrieved, so you can easily use the Services features that you customized. You have the ability to accept or decline cookies. Most web browsers automatically accept cookies, but you can usually modify your browser setting to decline cookies if you prefer. If you choose to decline cookies, you may not be able to fully experience the interactive features of the Services.
Consent to personal data processing (Meditrial EDC System Users)
a Meditrial EDC System User you will be required to tick a box in
order to provide your consent to personal data processing for the
This box concerns the consent to personal data processing for the services provision, compliance and prevention of misuse or fraud. Please note that this consent is essential to provide you with the requested service: therefore, if you do not tick this box, the service cannot be supplied.
Changes to this statement
Meditrial will occasionally update this Statement of Privacy to reflect company and customer feedback. Meditrial encourages you to periodically review this Statement (https://login.medigensuite.com/#/policy-statement) to be informed of how Meditrial is protecting your information.
Meditrial welcomes your comments regarding this Statement of Privacy. If you believe that Meditrial has not adhered to this Statement, please contact Meditrial at firstname.lastname@example.org. We will use commercially reasonable efforts to promptly determine and remedy the problem.
Last update: 2020/04/01