This section only applies to patients and healthcare professionals participating in an H3 Biomedicine Inc. (“H3B”) sponsored clinical trial taking place in the European Economic Area and/ or the UK
This section only applies if you are a patient or healthcare professional participating in an H3 Biomedicine Inc. (“H3B”) sponsored clinical trial which is taking place in the European Economic Area (“EEA”) and/ or the United Kingdom (“UK”). You will also be provided with detailed information in an Informed Consent Form/ Patient Information Sheet (ICF), which you should sign before you participate in a H3B sponsored clinical trial.
Under European Union and UK data protection laws (the General Data Protection Regulation (“GDPR”) and Data Protection Act 2018), H3B as sponsor of the clinical trial will be the ‘controller’ of your personal data collected a) for the clinical trial and b) for future scientific research purposes. H3B’s details are:
H3 Biomedicine Inc.
(United States Research Subsidiary of Eisai Co., Ltd.)
300 Technology Square
Cambridge, MA 02139
How to contact us
H3B’s Data Protection Officer
You can contact H3B’s Data Protection Officer by using the email address Data_Protection_EMEA@Eisai.net
H3B’s GDPR Representative in the EEA
H3B's data protection representative under the GDPR is Eisai GmbH of Edmund-Rumpler-Str. 3, 60549 Frankfurt am Main, Germany, who can be contacted at this address or by e-mail on firstname.lastname@example.org.
H3B’s UK Representative
H3B's data protection representative under the Data Protection Act 2018 is Eisai Europe Limited of European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom, who can be contacted at this address or by e-mail on Data_Protection_EMEA@Eisai.net.
1. For Patients
1.1 When do we collect information about you?
We collect information about you when you participate in an H3B sponsored clinical trial.
1.2 What information do we collect about you?
We only collect information about you that is relevant to the H3B sponsored clinical trial. The investigator site (hospital/clinic) conducting the clinical trial may collect the following on H3B’s behalf:
- Name, address, contact number(s) and email address
- Year of birth or date of birth (if permitted in your country and required by the trial protocol)
- Ethnic origin (if permitted in your country and required by the trial protocol)
- Health conditions
- Height and weight
- Medical history, procedures, test results, and other health data collected about your taking part in the trial
To ensure privacy and the scientific integrity of the clinical trial, your name and address will not be disclosed outside the clinic/hospital and you will only be identified by a code. This code will be attached to records or samples released to the Sponsor and the service providers associated with the clinical trial. Only the trial doctor and authorised persons will be able to connect this code to your name by means of a list. Further information can be found in the ICF.
1.3 How do we use your personal data?
The information we collect from you will be used to carry out and monitor the trial, to conduct and analyze test results, and for trial auditing purposes. It may also be used for further scientific research. This will be explained to you in detail in the ICF.
All information collected about you will be kept confidential. Authorized persons who look at your medical records will have a duty of confidentiality to you as a patient. Any of your medical records and the data collected for the clinical trial may be looked at by the parties listed in 3.2.
If you take part in a clinical trial, your primary physician will be informed in order that if you need to see your primary physician for any reason, he/she will be aware that you are taking part in the clinical trial.
The legal basis we rely on to process your personal data will be specified in the ICF and can vary by country due to applicable laws, but will either be:
- consent from you;
- H3B’s legitimate interests (to conduct scientific research into the efficacy and safety of pharmaceutical products/ trial drugs);
- compliance with a legal obligation (under Clinical Trial laws and in relation to the reporting of safety and quality issues);
- necessary for reasons of public interest in the area of public health such as ensuring the high standards of quality and safety of medicinal products (in relation to the reporting of safety and quality issues); and
- scientific research.
1.4 How long we keep your data
All personal data collected about you during this clinical trial (other than samples) will be stored for 25 years or longer if used for further scientific research or if required by applicable laws. Samples may be stored for testing for up to 15 years after the completion of the clinical trial, or until the sample is gone (if before).
2. For Healthcare professionals
2.1 When do we collect information about you?
We collect information about you when you participate in an H3B sponsored clinical trial.
2.2 What information do we collect about you?
We only collect information about you that is relevant to the H3B sponsored clinical trial and as detailed in the privacy statement provided to you for the clinical trial. This may include:
- Your name;
- Your contact information such as your address, email or telephone number;
- Your curriculum vitae and professional information such as areas of medical specialisation;
- any significant financial relationship with H3B as the Sponsor;
- information needed for payment processing; and
- any additional personal data you may have provided unsolicited in your curriculum vitae or other documents.
2.3 How do we use your personal data?
Clinical trial regulations such as those associated with the ICH/GCP Guidelines and those adopted by local jurisdictions oblige H3B as the sponsor of a clinical trial and those acting on the sponsor’s behalf (such as a CRO) to collect personal data from individuals who participate in the conduct of a clinical trial to prove their qualifications.
The personal data you provide will become part of the clinical trial databases and paper files as needed for the implementation, performance, and record-keeping (archiving) of the clinical trial. These databases and files are used to (1) manage your and the investigative site(s) at which you work participation in the clinical trial, (2) communicate with you and the investigative site(s) in connection with the clinical trial, and (3) to carry out other clinical trial activities for the clinical trial as required or permitted by law.
The legal bases H3B relies upon to process your personal data are, as applicable:
- compliance with a legal obligation (including clinical trial regulations such as those associated with the ICH/GCP Guidelines and those adopted by local jurisdictions obliging H3B as the sponsor and those acting on its behalf to collect personal data from individuals who participate in the conduct of a clinical trial to prove their qualifications, and for the purpose of drug safety reporting and quality issues, and to store clinical trial data);
- H3B’s legitimate business interests to conduct scientific research into the efficacy and safety of pharmaceutical products/ trial drugs;
- as is necessary for scientific research purposes (namely the use of your personal data in connection with the use, analysis and retention of patient personal data in the clinical trial);
- as is necessary for reasons of public interest in the area of public health (such as ensuring the high standards of quality and safety of medicinal products through reporting and monitoring drug safety and quality issues);
- H3B and its affiliated companies’ legitimate business interests to determine your potential involvement in the future activities of H3B and its affiliated companies.
2.4 How long we keep your data
All personal data collected about you during this clinical trial will be stored for 25 years or longer if required by applicable laws.
3. Rights, sharing your data, changes to this privacy statement and how to contact
3.1 What are your rights?
In respect of the personal data that we have collected about you, you have the right, in certain circumstances, to:
- Request access to this personal data,
- Request the correction of this personal data,
- Request the erasure of this personal data,
- Request that we restrict how we process this personal data,
- Object to how we process this personal data, and
- Request a copy of the personal data you have provided to H3B in an electronic format.
You can also withdraw your consent to the processing of your personal data at any time but this will not affect the lawfulness of the processing before that time.
We will consider any such request made in accordance with applicable data protection laws. However, please note that in order to protect the scientific integrity of the clinical trial, the treatment you receive in this clinical trial and the results from the treatment might need to remain confidential until the clinical trial data is analysed. In addition, there may be a legal or other valid reason why H3B may not be able to process your request in whole or in part and your rights may be superseded by H3B’s legal obligations as described by specific applicable laws.
Where you have requested that we delete your personal data, we will either delete or anonymise this personal data. Where it is not possible for us to delete or anonymise your personal data we will take steps to put the personal data beyond use where it will be securely stored until such time as we are able to delete or anonymise it.
If you would like to make a request to access, correct or delete the personal data we have collected about you, please send an email to Data_Protection_EMEA@Eisai.net.
You have a right to complain to your national data protection authority if you are not satisfied with the way we are handling your data. The current list of the authorities is available at: http://ec.europa.eu/justice/data-protection/article-29/structure/data-protection-authorities/index_en.htm.
3.2 Who do we share your data with?
We may share your data with:
- Authorised persons within H3B and other entities in the same group of companies as H3B (also see 3.3 below);
- Ethics committees to check that the trial is being carried out correctly;
- Monitors, auditors, representatives from laboratories, and other legitimate third party contractors or consultants who are helping H3B;
- Third-party suppliers or potential suppliers who provide related services or business systems used by to H3B to securely process your data;
- Representatives from health/regulatory authorities such as the United States Food and Drug Administration (FDA), and our regulators and/ or any other competent authority who have powers to request disclosure of personal information we hold;
- Professional advisors;
- Pharmaceutical companies with whom H3B and other entities in the same group of companies as H3B have a co-promotion/ co-marketing relationship;
- A purchaser or potential purchaser of any business or asset that we are selling (or are contemplating selling); and/or
- Third parties where required by law.
3.3 Sharing your data outside the EEA and UK
Personal data we collect from you may be transferred to countries outside the EEA and UK, including to the USA where H3B is located. As part of an international organisation, H3B operates in a number of countries including Japan.
We also use third party suppliers to provide clinical trial services to help operate and complete the clinical trial, and we share your personal data with these third party service providers. Some of these providers may be outside the EEA and UK.
Some countries outside the EEA and UK may not have a data protection supervisory authority and/ or data processing principles and/ or data subject rights might not be provided for in that country, so you might not be able to enforce your rights in the same way, and recipient organisations may not be legally required to secure your data to EU and UK standards. H3B shall take all necessary steps to ensure that your personal data is protected in such circumstances.
We maintain processes to ensure that any third party we are using and who will process your data, including other entities in the same group of companies as H3B, will comply with same standards to protect your data as in the EEA and UK. This includes carrying out necessary due diligence on such third parties (for example, the security measures they have in place for protecting data), and entering into contracts which contain adequate contractual measures to protect data, which can include contracting on standard contractual clauses which have been approved by EU authorities as providing adequate protection for your personal data.
3.4 Changes to this privacy statement
This privacy statement may be updated by H3B from time to time; please visit www.h3biomedicine.com website at any time to view the latest version.