Clinical Trial Privacy Notice
IMPACT Therapeutics Inc. (IMPACT) (data controller) is a clinical-stage biopharmaceutical company who focus the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality.
This notice applies to individuals based in the EU who are participants in the following clinical trials:
· IMPACT Therapeutics Inc (IMPACT) is the Sponsor of a phase 2, randomized, double-blind, placebo-controlled, multi-centre trial to evalsuate Senaparib maintenance in mCRPC patients with homologous recombination repair gene alterations after docetaxel treatment.
In most instances, your personal data will be de-identified when transferred outside of the EEA and replaced by a subject ID. This will mean your data such as your name and contact details will not be transferred.
Our lawful basis for each purpose is included.
|
Purpose |
Types of data |
Lawful basis |
Retention |
|
Screening and Recruitment |
Demographic (name, country, contact details etc.) and Health Data |
Article 6(1)(f) – legitimate interest and Article 9(2)(j) research purposes |
25 years as per the EU Clinical Trials Regulation (536/2014) |
|
Operations of the clinical trial |
Health Data |
Article 6(1)(f) – legitimate interest and Article 9(2)(j) research purposes |
25 years as per the EU Clinical Trials Regulation (536/2014) |
|
Pharmacovigilance |
Health and Trial data |
Article 6(1)(c) legal obligation and Article 9(2)(i) necessary for ensuring high standards and quality of medicinal products |
25 years as per the EU Clinical Trials Regulation (536/2014) |
Where we rely on our legitimate interest which is the development of products which can support and treat those living with certain conditions. We are carrying out this research study to explore whether this medical strategy and treatment and is safe and effective for humans.
We also rely on our legal obligation under the EU Clinical Trial Regulation (536/2014) to ensure the safety of our participants.
All individuals have consented to take part in the clinical trial and can withdraw from the study at any time.
Rights
The GDPR provides certain rights for Data Subjects which include:
In the majority of cases, it will be free to exercise these rights and IMPACT will respond within a period of one month.
Please contact IMPACT’s EEA Representative details dpr.impacttherpeutics@kdpc.es or Data Protection Officer dpo.impacttherapeutics@kdpc.uk if you wish to exercise any of your rights.
Transfers
IMPACT is based in China, and as such your personal data will be transferred to China, and to our trusted suppliers based in Singapore, Switzerland, and the United States of America all of which work under strict contract with IMPACT. We must inform you that currently China, Singapore, Switzerland and the United States have a different data protection regime to the regime in the EU, which is not deemed to provide an adequate level of protection for the purposes of EU data protection legislation. To maintain security of this data, personal data is only transferred to IMPACT and its trusted suppliers when strictly necessary and under the EU’s Standard Contractual Clauses which provide safeguards for these transfers. We have put in place other safeguards to protect your personal data such as encryption and only your subject ID, gender, ethnicity, and research data will be sent outside of the EEA.
IMPACT has appointed a European Economic Area (EEA) Representative who you can contact directly if you have any questions or concerns about how we use your personal data during and after the clinical trial:
Recipients
Categories of recipients who will have access to your personal data will be the trial site study team, IMPACT’s: study team, drug safety team, trial monitoring team and drug management board and also clinical trial and medicinal product regulators.
Retention
Personal Data will be retained for 25 years in line with the EU regulatory requirement for clinical trial data (EU Clinical Trials Regulation (536/2014)).
Contact
If you have any queries regarding the processing activities, you can contact our European Economic Area (EEA) representative: dpr.impacttherpeutics@kdpc.es
Our Data Protection Officer can be contacted at dpo.impacttherapeutics@kdpc.uk If we are unable to resolve your query, you may contact your local Supervisory Authority.
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