Your personal data will be processed to accomplish the following purposes: 

1. Managing your role and/or participation in the trial and communicate with you regarding the trial.
2. Seeking approval for the trial and/or Investigational Medicinal Product (the “IMP”) by governmental or regulatory authorities.
3. Satisfying any legal or regulatory requirements affecting the trial and/or IMP
4. For public disclosure by competent authorities as required by legal or regulatory requirements in connection with the trial conduct and/or marketing authorisation of the IMP.
5. Submitting the trial for publication on mandatory websites and databases that serve a comparable purpose
6. Complying with reporting obligations of applicable laws and regulations or national industry code requirements regarding disclosure of transfer of value from pharmaceutical companies to healthcare professionals; in those cases, in which it is not possible to do it on an aggregated basis.
7. Reporting any adverse reaction and complying with applicable pharmacovigilance obligations.
8. Storage in ALK's site database kept for the purposes of selecting sites in future clinical trials.

ALK will collect your personal data from you directly and/or from the institution where you work or support research activities.

ALK may share your personal data with others in connection with the purposes described in this notice, and we may make your personal data available to:

i. ALK EMPLOYEES & EXTERNAL PROCESSORS

The recipients of your personal data will be employees of entities belonging to the ALK Group and external processors providing specific services and processing personal data on our behalf (i.e. CROs, infrastructure and IT service providers, as well as third-party consultants). They will receive your personal data only on a ‘need-to-know’ basis, subject to confidentiality obligations and after signing appropriate legal agreements.

ii. INDEPENDENT THIRD PARTIES

When needed, we may disclose your personal data to independent third parties such as attorneys, public authorities, ethic committees/institutional review boards, regulators, external shipment or payment providers or third-party auditors.

iii. TRANSFERS OF DATA FROM EU/EEA TO THIRD COUNTRIES

In some cases, the third parties may be located in countries outside the European Economic Area (EEA) that may not be considered as providing an adequate level of protection of Personal Data; in these cases, ALK will rely on appropriate safeguards such as binding corporate rules/standard contract clauses, the EU-US Data Privacy Framework or on the need to perform the contract with the third party or on the need of the establishment, exercise or defence of legal claims in accordance with articles 46, 49(1)(c) and 49(1)(e) of GDPR.

Under the General Data Protection Regulation (GDPR), you have certain data protection rights:

1. Right to access
   You have the right to request access to your personal data held by ALK, as well as additional details.
2. Right to rectification
   You have the right to request correction of inaccurate or incomplete personal data.
3. Right to erasure
   Under certain circumstances, you may have the right to obtain deletion of your personal, prior to the expiry of our general retention periods.
4. Right to restrict processing
   Under certain circumstances, you may have the right to request the restriction of your personal data.
5. Right to object
   You have the right to object to the processing of your personal data.
6. Right to data portability
   In specific situations, you are entitled to receive your personal data in a structured, widely used, and machine-readable format.

You can withdraw your consent at any time by contacting us using the contact details provided in Section 1.