Privacy Notice for Participants
WHAT IS THE PURPOSE OF THIS DOCUMENT?
ClinEdge (“we”, “our”, “us”) is committed to protecting the privacy and security of your personal information in accordance with applicable laws. This privacy notice describes how your personal information will be collected and used. It applies to all visitors to this participant website and anyone who takes part in the recruitment process to be a participant in a clinical trial at the trial sites conducted on behalf of Mayne Pharma. If you go on to participate in a clinical trial, you will be provided with further privacy information at that time.
This participant website is owned and operated by ClinEdge. ClinEdge will process personal information about you on behalf of Mayne Pharma who are the “data controller” for this processing activity. Mayne Pharma will not receive identifiable personal information from ClinEdge. It is important that you read this notice, together with any other privacy notice we may provide on specific occasions when we are collecting or processing personal information about you, so that you are aware of how and why we are using such information.
THE TYPE OF INFORMATION WE HOLD ABOUT YOU
Personal data, or personal information, means any information about an individual from which that person can be identified. It does not include data where the identity has been removed.)
There are “special categories” of more sensitive personal data which require a higher level of protection.
We will collect, store, and use the following categories of personal information about you:
- Personal contact details such as name, title, addresses, telephone numbers, and personal email addresses
- Date of birth
- Next of kin and emergency contact information
- National Insurance number
- Bank account details
- Copy of driving license/passport or other national identity document
We may also collect, store and use the following “special categories” of more sensitive personal information:
- Information about your health, including any medical condition, health and sickness records
- Genetic information and biometric data
- Race and ethnicity information
HOW IS YOUR PERSONAL INFORMATION COLLECTED?
We collect personal information about you when you visit our website and directly from you if you choose to apply to become a participant. We may sometimes collect additional information from third parties such as your General Practitioner or other health professional.
We may collect additional personal information in the course of activities throughout the period in which you participate with us.
HOW WE WILL USE INFORMATION ABOUT YOU
We will use your personal information in accordance with applicable law. Most commonly, we will use your personal information in the following circumstances:
- Where we need to perform the agreement that we have entered into with you
- Where we need to comply with a legal obligation
- Where it is necessary for our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests
- Where you consent to its use
We may also use your personal information in the following situations, which are likely to be rare:
- Where we need to protect your interests (or someone else’s interests), such as for safety reasons
- Where it is needed in the public interest or for official purposes
Situations in which we will use your personal information
We need all the categories of information in the list above primarily for our legitimate interests in providing a participant website to provide information about clinical trials to you, to maintain a database of potential participants for clinical trials, to conduct any screening or health checks to assess your suitability for clinical trials and to contact you about trials you may be interested in. In some cases, we may use your personal information to pursue legitimate interests of our own or those of third parties, provided your interests
and fundamental rights do not override those interests. The situations in which we will process your personal information are listed below.
- Providing a participant website to provide information about clinical trials to
- To maintain a database of potential participants for clinical
- To conduct any screening or health checks to assess your suitability for clinical
- To contact you about trials you may be interested
- Complying with health and safety
- To prevent
- To monitor your use of our information and communication systems to ensure compliance with our IT
- To conduct data analytics studies to review and better understand participant
- To conduct
Some of the above grounds for processing will overlap and there may be several grounds which justify our use of your personal information.
HOW WE USE PARTICULARLY SENSITIVE PERSONAL INFORMATION
“Special categories” of particularly sensitive personal information require higher levels of protection. We need to have further justification for collecting, storing and using this type of personal information. We may process special categories of personal information in the following circumstances:
- With your explicit
- Where we need to carry out our legal
- Where it is needed in the public
- Where it is needed to assess your health or safety, subject to appropriate confidentiality
Less commonly, we may process this type of information where it is needed in relation to legal claims or where it is needed to protect your interests (or someone else’s interests) and you are not capable of giving your consent, or where you have already made the information public.
Our Obligations as Data Controller
We will use your sensitive personal information in the following ways:
We will use information about your physical or mental health, or disability status, to assess your suitability to take part in a clinical trial, to identify trials for which you might be suitable, to conduct testing and medical procedures if you go on to take part in a clinical trial and to liaise with your GP if needed.
Do we need your consent?
We need your consent to use your special categories of information, such as health information. Cookies
We do not envisage that any decisions will be taken about you using automated means, however we will notify you in writing if this position changes.
We may have to share your data with third parties, including third-party service providers and other entities in the group. We require third parties to protect the security of your data and to handle it in accordance with the law.
Why might you share my personal information with third parties?
We will share your personal information with third parties where required by law, or where we have another legitimate interest in doing so, such as to enable us to maintain our participant database or let you know about a clinical trial.
The main service providers we use are:
|Service Provider||Type of processing||Location of processing|
|WordPress||CMS system for website||US|
|Salesforce||Aggregation of data||US|
|GoDaddy||GoDaddy host our website, so enabling us to process your initial online application.||US|
|CallTrackingMetrics||CallTrackingMetrics is our call tracking phone system utilized by enrollment specialists to follow up with potential patients who’ve submitted their interest on the website.||US|
If you choose to participate in a clinical trial conducted on behalf of Mayne Pharma, Mayne Pharma may process your information because:
- You have given Mayne Pharma permission to do so;
- Mayne Pharma has a contract with you;
- Mayne Pharma must provide services to you after you have enrolled in a clinical trial;
- Mayne Pharma has legitimate interests to do so, namely IT security, fraud prevention and administering its business, or the performance of a contract between you and Mayne Pharma, or taking steps at your request to enter into such a contract;
- For Sensitive Personal Data, as required or permitted by applicable laws, it is necessary to carry out Mayne Pharma’s obligations and to exercise specific rights in relation to the conduct of a particular clinical trial, it is necessary to establish, exercise or defend legal claims, you have manifestly made public your information, or you have given prior explicit consent;
- Mayne Pharma is enforcing its legal rights pursuant to the laws of the jurisdiction from which the data was collected, or in other cases if Mayne Pharma believe in good faith that disclosure is required by law;
- Mayne Pharma is complying with a legal obligation to which it is
Transferring information outside the European Union
For European Union (EU) residents, we may transfer the personal information collected about you outside of the EU, including to the USA (where some of our group companies are based), in order to provide our services to you. We use a variety of legal mechanisms to help ensure that your rights and protections follow personal data transferred from the European Economic Area and Switzerland to countries that have not been determined by the European Commission to have an adequate level of data protection. These mechanisms include standard contractual clauses approved by the European Commission, and your consent.
We have put in place measures to protect the security of your information, some of which are shown below. Further details of these measures are available upon request.
Third parties will only process your personal information on our instructions and where they have agreed to treat the information confidentially and to keep it secure.
We have put in place appropriate security measures to prevent your personal information from being accidentally lost, used or accessed in an unauthorized way, altered or disclosed. In addition, we limit access to your personal information to those employees, agents, contractors and other third parties who have a business need to know. Those third parties will only process your personal information on our instructions and they are subject to a duty of confidentiality. Please be aware though that, despite our best efforts, no security measures are perfect or impenetrable.
If you have questions about our Data Retention Policy, please contact: GDPR@clin-edge.com.
We will retain your personal data for the length of time needed to fulfill the purposes outlined in this notice unless a longer retention period is required or permitted by law. Because these needs can vary for different data types in the context of different products, actual retention periods can vary significantly. The criteria we use to determine the retention periods include:
- a specific retention period for a certain data type adopted and announced by us;
- the period for which the personal data is needed to provide our services and products and to operate our business (including maintaining and improving the performance of our services and products, keeping our systems secure, and maintaining appropriate business and financial records), as a general rule that establishes the baseline for most data retention periods;
- a longer period if there is no automated control that enables you to access and delete the personal data at any time;
- a shorter period if the personal data is a sensitive type;
- a period required by a legal, contractual, accounting or similar obligation to retain the data (such as mandatory data retention laws in the applicable jurisdiction, government orders to preserve data relevant to an investigation or legal holds in anticipation of litigation);
- a period dictated by the statute of limitations on legal actions related to the subject matter of the data;
- a period necessary to protect your vital interests or the vital interests of another natural person
We will respect your legal rights to your data.
For EU residents, you also have the following rights with respect to your personal data:
- to request access to your personal
- to correct any inaccuracies in your personal
- to erasure (to be forgotten), meaning upon your request, we must erase the personal data stored about
- The right to be forgotten is not absolute (guaranteed) and is evaluated on a case-by-case
- to restrict processing of your personal data;
- for example, if the processing is unlawful or if the personal data is no longer needed for the purposes of processing but is required by you for the establishment, exercise, or defense of claims, e.g., as documentation or
- to object to the processing of your personal data; this is evaluated on a case-by-case
- to receive your personal data and transfer it to a third-party.
- to withdraw your consent to data processing;
- everything collected prior to your withdrawal may still be
These requests can be made online: https://clin-edge.com/data-subject-requests-gdpr/ Or by mail: 108 Myrtle St, Quincy, MA, 02171 Attention: DPO
What We May Need From You
We may need to request specific information from you to help us confirm your identity and ensure your right to access the information (or to exercise any of your other rights). This is another appropriate security measure to ensure that personal information is not disclosed to any person who has no right to receive it.
RIGHT TO WITHDRAW CONSENT
In any circumstances where you may have provided your consent to the collection, processing and transfer of your personal information for a specific purpose, you have the right to withdraw your consent for that specific processing at any time. To withdraw your consent, visit https://clin-edge.com/data-subject-requests-gdpr/ Or by mail: 108 Myrtle St, Quincy, MA, 02171 Attention: DPO. Once we have received notification that you have withdrawn your consent, we will no longer process your information for the purpose or purposes you originally agreed to, unless we have another legitimate basis for doing so in law. Please note that this withdrawal does not apply to the extent that we have already acted upon the information received.
CHANGES TO THIS PRIVACY NOTICE
We reserve the right to update this privacy notice at any time.
If you have any questions about this privacy notice, please contact us, via email at GDPR@clin-edge.com.