AUDENTES THERAPEUTICS, INC.
As adopted July 27, 2018
III. Contact details
600 California St, 17th Floor
San Francisco, CA 94108
You have the right to make a complaint at any time to your applicable supervisory authority. We would, however, appreciate the chance to address your concerns before you approach the supervisory authority in your country, so please contact us in the first instance.
It is important that the personal data we hold about you is accurate and current. Please keep us informed if your personal data changes during your relationship with us.
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, otherwise known as anonymous data. To help ensure that your child’s personal data is kept confidential, the data will be stored in a “pseudonymized” manner (encoded) and pseudonymized prior to analysis or prior to transfer to third parties. “Pseudonymized” means, that your child’s name, initials or any other information that directly identifies your child will not be used, but only a study-specific numeric or letter code and eventually your child’s year of birth.
We may collect, use, store and transfer different kinds of personal data about you for clinical trial purposes if you consent to participate. We have grouped these together as follows:
Special Categories of Personal Data may include your race or ethnicity, religious or philosophical beliefs, information about your health, and genetic and biometric data. Special Category Data has stringent security and confidentiality requirements, to which we adhere, and we always ask your consent to process this. Please see our consent form “PARENT’S INFORMATION AND CONSENT FOR THEIR CHILD TO PARTICIPATE IN A CLINICAL RESEARCH STUDY” for more information.
We also collect, use and share Aggregated Data such as statistical or demographic data for research purposes. Aggregated Data could be derived from your personal data but is not considered personal data in law as this data will not directly or indirectly reveal your identity.
We use different methods to collect data from and about you, including through:
- Direct interactions. You may give us your or your child’s personal information by filling in forms or by corresponding with us by post, phone, email or otherwise. This includes personal data you provide when you:
- Indirect interactions through clinical trial sites (Audentes will receive pseudonymized data only)
- Fill in forms or by corresponding by post, phone, e-mail or otherwise
This includes personal data you provide when you:
- Fill in the consent form;
- Enrol in the clinical trial;
- Contact us;
- Allow video recordings or images for the purpose of this study.
- Third parties. We may receive personal data about you or your child from other third parties as set out below:
- Special Category Data from other companies helping to manage the study or perform bioanalyses;
- Travel vendors helping to support families traveling for the clinical trial;
- Contact, Financial and Transaction Data from providers of technical, payment and delivery services based outside the EU
- Contract Research Organizations (CROs)
Audentes will only use your or your child’s personal data when you give consent to participate in a clinical research study and we will do so in order to undertake the study safely and accurately. We may also use your personal data where we need to comply with a legal obligation.
Please read the “PARENT’S INFORMATION AND CONSENT FOR THEIR CHILD TO PARTICIPATE IN A CLINICAL RESEARCH STUDY” for a comprehensive overview of the study and the ways in which we will be using your child’s data.
IV. Opting out
You can opt-out by contacting us at any time. The consent to the collection, use, processing and transfer of your child’s personal data is irrevocable. If you revoke your consent to your child’s participation in the study, your child’s personal data stored up to this point can still be used as long as this is necessary to:
- establish the effects of the investigational drug
- ensure that any of your child’s interests that need protection are not affected
- satisfy the obligation to supply full documentation for authorization purposes.
If you withdraw your consent, no further data will be collected for you or your child. However, all existing data and video that have already been collected will be retained and used in the analysis of the study results. Additional analyses of the data in your child’s records may be conducted by combining anonymous information from individual Audentes clinical studies.
V. Change of purpose
We will only use your personal data for the purposes for which we collected it, unless we reasonably consider that we need to use it for another reason and that reason is compatible with the original purpose. If you wish to get an explanation as to how the processing for the new purpose is compatible with the original purpose, please contact us.
If we need to use your personal data for an unrelated purpose, we will notify you and we will explain the legal basis which allows us to do so.
Please note that we may process your personal data without your knowledge or consent, in compliance with the above rules, where this is required or permitted by law.
We may share your personal data with the parties set out below.
- Third Parties
- Other vendors participating in the clinical trial
- Physicians participating in the clinical trial
- Presentations or conferences where pseudonymized data is presented
We require all third parties to respect the security of your personal data and to treat it in accordance with the law. We do not allow our third-party service providers to use your personal data for their own purposes and only permit them to process your personal data for specified purposes and in accordance with our instructions.
We are based in the United States of America. This will involve transferring your data outside the European Economic Area (EEA).
- We will provide an appropriate level of protection for you and your child’s personal data, as outlined by the European Commission. For further details, see European Commission: Adequacy of the protection of personal data in non-EU countries.
- Where we use certain service providers, we may use specific contracts approved by the European Commission which give personal data the same protection it has in Europe. For further details, see European Commission: Model contracts for the transfer of personal data to third countries.
- As we are based in the US, we are part of the Privacy Shield which requires us to provide similar protection to personal data shared in Europe. For further details, see European Commission: EU-US Privacy Shield.
Please contact us if you want further information on the specific mechanism used by us when transferring your personal data out of the EEA.
We have put in place appropriate security measures to prevent your personal data from being accidentally lost, used or accessed in an unauthorized way, altered or disclosed. In addition, we limit access to you and your child’s personal data to those employees, and third parties who have a need to know for the purposes of the trial. They will only process your personal data on our instructions and they are subject to a duty of confidentiality.
We have put in place procedures to deal with any suspected personal data breach and will notify you within 72 hours upon learning of the suspected breach.
We will only retain personal data for as long as reasonably necessary to fulfil the purposes for which we collected it, including for the purposes of satisfying any legal, regulatory, tax, accounting or reporting requirements. We may retain your personal data for a longer period in the event of a complaint or if we reasonably believe there is a prospect of litigation in respect to our relationship with you.
To determine the appropriate retention period for personal data, we consider the amount, nature and sensitivity of the personal data, the potential risk of harm from unauthorized use or disclosure of your personal data, the purposes for which we process your personal data and whether we can achieve those purposes through other means, and the applicable legal, regulatory, tax, accounting or other requirements.
Under certain circumstances, you and your child have rights under data protection laws in relation to personal data. These are as follows:
Request access to your or your child’s personal data (commonly known as a “data subject access request”). This enables you to receive a copy of the personal data we hold about you or your child and to check that we are lawfully processing it.
Request correction of the personal data that we hold about you or your child. This enables you to have any incomplete or inaccurate data we hold to be corrected, though we may need to verify the accuracy of the new data you provide to us.
Request erasure of your or your child’s personal data. This enables you to ask us to delete or remove personal data where there is no good reason for us continuing to process it. You also have the right to ask us to delete or remove personal data where you have successfully exercised your right to object to processing (see below), where we may have processed your information unlawfully or where we are required to erase your personal data to comply with local law. Note, however, that we may not always be able to comply with your request of erasure for specific legal reasons which will be notified to you, if applicable, at the time of your request.
Object to processing of your or your child’s personal data where we are relying on a legitimate interest (or those of a third party) and there is something about your particular situation which makes you want to object to processing on this ground as you feel it impacts on your fundamental rights and freedoms. In some cases, we may demonstrate that we have compelling legitimate grounds to process information which override your or your child’s rights and freedoms.
Request restriction of processing of your or your child’s personal data. This enables you to ask us to suspend the processing of your personal data in the following scenarios:
- If you want us to establish the data’s accuracy.
- Where our use of the data is unlawful, but you do not want us to erase it.
- Where you need us to hold the data even if we no longer require it as you need it to establish, exercise or defend legal claims.
- You have objected to our use of your or your child’s data, but we need to verify whether we have overriding legitimate grounds to use it.
Request the transfer of your or your child’s personal data to you or to a third party. We will provide to you, or a third party you have chosen, your personal data in a structured, commonly used, machine-readable format. Note that this right only applies to automated information which you initially provided consent for us to use or where we used the information to perform a contract with you.
Withdraw consent at any time where we are relying on consent to process your or your child’s personal data. However, this will not affect the lawfulness of any processing carried out before you withdraw your consent. If you withdraw your consent, we may not be able to provide certain products or services to you. We will advise you if this is the case at the time you withdraw your consent.
VI. 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 your personal data (or to exercise any of your other rights). This is a security measure to ensure that personal data is not disclosed to any person who has no right to receive it. We may also contact you to ask you for further information in relation to your request to speed up our response. Please contact us if you wish to exercise any of the rights set out above. You will not have to pay a fee to access your personal data (or to exercise any of the other rights). We will try to respond to all legitimate requests within one month.