Politica de Privacidade

AICIB is committed to ensuring that personal data is:

• Processed lawfully, fairly, and transparently in relation to the data subject;
• Collected for specific, explicit, and legitimate purposes and not further processed in a manner that is incompatible with those purposes;
• Adequate, relevant, and limited to what is necessary in relation to the purposes for which it is processed;
• Accurate and, where necessary, kept up to date; all reasonable steps are taken to ensure that personal data which is inaccurate, having regard to the purposes for which it is processed, is erased or rectified without delay;
• Kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data is processed;
• Processed in a manner that ensures appropriate security of the personal data, including protection against unauthorised or unlawful processing and against accidental loss, destruction, or damage, using appropriate technical or organisational measures.

The Data Controller for the personal data collected through the website is AICIB – Agência de Investigação Clínica e Inovação Biomédica, with its registered office at Rua de Santa Catarina, 1288, 4000-099 Porto, Portugal.

For any privacy-related matters, you may contact AICIB via email at aicib@aicib.pt or reach out to its Data Protection Officer (DPO) at the following email address: privacy@aicib.pt.

Clients who have contracted our services may authorise certain users to access those Services, including users who are not directly affiliated with or controlled by the Client. These Authorised Users may include:

• Clinical trial participants,
• Other clinical trial stakeholders,
• Healthcare professionals,
• Clinical trial monitors, and
• Administrators or executives from hospitals, clinics, or other study sites.

In such cases, the Client acts as the administrator of those accounts and of any personal data that such Authorised Users may provide in connection with the contracted Services. The access of these Authorised Users to the Services is governed by AICIB’s Terms and Conditions.

Study Participants who access technology enablement services or products, including any software or tools made available to Authorised Users, will have only a minimum amount of personal data collected—sufficient solely to enable workflows defined by the Client and to meet our contractual and legal obligations. This personal data will not be used for any other purpose, nor will it be disclosed to unauthorised third parties.

AICIB collects information about individuals who access or interact with the Portugal Clinical Studies Platform (“Platform”) and who voluntarily provide personal data, either directly, when contracting Products or Services, or indirectly, when such data is supplied by authorised third parties.

1. Categories of Personal Data We May Collect

“Personal data” means any information that identifies or relates to an identifiable individual. We may collect and process some or all of the following:

• Identification and contact details: name, surname, email address, phone number;
• Employment details: employer name, office location, job title;
• Browsing and tracking activities on the Platform;
• Professional experience and affiliations;
• Commercial information: purchase history and preferences;
• Sensory and electronic information: e.g. audio recordings during teleconsultations, webinars, online meetings, remote training or support sessions (where applicable);
• User profile images, where applicable;
• Username and authentication credentials for service access;
• Special categories of personal data: such as health-related data, when integrated by the Client or directly provided by the Study Participant as part of the study they are involved in;
• Account and profile information: data collected when users are invited to join an organisation, authorised to access services, register an account, edit profiles or preferences, or register another person;
• Other data typically collected: contact information, billing details, organisation name, role, and other account-related information.

2. Collection Methods

We collect personal data through the following channels:

Directly from users or Clients, when:

• Registering on the Platform or subscribing to a service;
• Interacting with our services or Partner Providers;
• Contacting us or using our support channels.

Via the Client (authorised data controllers), when:

• Clients assign authorised users to access the services;
• Clients upload or submit data in connection with a study.

Automatically, when:

• Accessing the Platform, via:
  • Cookies and tracking tools (see cookie categories below);
  • Log data: e.g. IP address, browser type and version, visited pages, time and duration of visit;
  • Device and connection info: e.g. device type, OS, browser settings, and use context.

3. Data from Platform and Service Use

We also collect:

• Content you provide on the Platform: e.g. submissions, account creation, service requests, messages to Partner Providers.
• Information from support channels: if you raise a support ticket, we may collect contact information, technical context, descriptions of issues, screenshots (please avoid including sensitive data in screenshots).
• Download activity data: IP address, email, and other identifying information may be collected when downloading content from our sites.
• Activity logs: interactions with the Platform and between authorised team members are logged for auditing purposes.
• Device information: includes type, connection, and configuration details relevant to service access.

4. Children and Underage Data

Our Site, Platform, and Services are not directed at individuals under 18 years of age. Clients conducting clinical studies involving minors must not submit any personal data that could directly or indirectly identify them, even if legal guardian consent has been obtained. Such data must be pseudonymised and protected with additional security measures.
If we become aware of personal data from minors submitted without proper protections or authorisation, we will cease processing and delete it.
Clients are solely responsible for the data they submit and for ensuring compliance when handling data relating to minors.

5. Cookies and Automated Tracking

We use cookies to enhance functionality and improve user experience. Cookies may collect:

• Browser type, time spent on pages, language preferences, and anonymous traffic data.

Types of cookies used:

• Strictly necessary cookies: essential for core platform functions; cannot be disabled.
• Performance cookies: provide statistical insights, e.g. for analytics.
• Functional cookies: allow enhanced features and personalisation.
• Targeting/advertising cookies: used to personalise content and show relevant ads.

Users must accept strictly necessary cookies to navigate the site and may choose which of the other cookies to accept.

Server or data centre administrators (e.g. Clients) may disable or block transmission of automated data collection at a network level.

6. Purposes for Data Processing

We process personal data to:

• Provide and manage services: authenticate logins, perform contracts, manage accounts, and support user workflows.
• Conduct research and development: analyse usage, solve technical issues, and improve services.
• Communicate with users: send transactional emails or service updates, offer training resources.
• Offer customer support: resolve issues, review failures, and maintain service functionality.
• Ensure security and compliance: monitor use for fraud prevention, enforce platform policies, and maintain audit trails.

All processing is done in compliance with applicable data protection laws, ensuring that your data is used lawfully, fairly, and for legitimate purposes only.

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We may share your personal data for the following commercial purposes:

• With our third-party service providers who deliver services such as information technology and related infrastructure, cloud storage, messaging and voice services, email delivery, data analytics, marketing analytics, auditing, software development and maintenance, quality control and assurance, customer support, and other services. These service providers are legally obliged to ensure the confidentiality of personal data and implement appropriate security measures.
• If necessary or appropriate under applicable law; to comply with legal processes; to respond to requests from public and governmental authorities; to enforce our terms and conditions; to protect our operations; to protect the rights, privacy, safety, or property of AICIB, the user, or third parties; and to enable us to seek available remedies or limit damages we may incur.

Legal basis for processing:

All personal data processing we carry out has at least one legal basis, which may be: (1) your consent; (2) the necessity of personal data for the execution of a contract or requested service; (3) compliance with a legal obligation to which we are subject; or (4) our legitimate interest or that of third parties under national or EU legislation. If we process your personal data based on your consent, you may withdraw it at any time, as described below.

Personal Data Retention:

We will retain and use personal data for as long as necessary to fulfil the purposes for which it was collected or provided, to comply with contractual and legal obligations, resolve any disputes, provide our services, enforce our contracts, and exercise other rights under applicable law. When applicable, we store personal data according to the instructions of our Clients who are the Data Controllers providing us with data through the Platform.

When there is no longer a legitimate need to retain data and information related to the Services or Products you have acquired, we will securely delete it permanently or, if that is not possible, securely store it until it can be safely destroyed. When we delete or destroy personal data, it will be removed from our active servers and databases, as well as from the Sites, but may remain in our archives where deletion is not practical or possible.

To the extent permitted by law and/or our contractual obligations, we may retain and use anonymised and aggregated information for performance reporting, benchmarking, and analytical purposes, to improve our Services and for other business or research purposes.

Information Security:

We take reasonable and appropriate administrative, technical, and organisational security measures to protect personal data and other confidential information, and we periodically review these security procedures considering new technologies and emerging security regulations. However, no security system is perfect, and no data transmission over the internet can be guaranteed to be completely secure. Although we strive to protect personal data, we cannot guarantee the absolute security of any information you transmit to or from our Services or Sites. You should always maintain appropriate security on the devices you or your authorised users use to access our Sites and Platforms. Whenever a link to external Sites not owned by AICIB is disclosed, you should consult the privacy policy and terms of use of the owner of those Sites or Platforms, as they are outside AICIB’s control.

Certain areas of the Sites or Services may require a user ID, email address, and/or password as an additional security measure to help protect your information. Do not share your password with anyone.

International Transfers:

The Portugal Clinical Studies Platform is based in Portugal and governed by Portuguese law. We do not transfer data outside the European Economic Area (“EEA”).

Important:
If you share or grant access to third parties, whether individuals or legal entities, whether or not involved in the Study, in any capacity, you are responsible for ensuring all legally required agreements, including Data Processing Agreements, are executed for compliance with the GDPR.

Your rights regarding personal data:

• Marketing or promotional communications: You may opt out of receiving our marketing or promotional emails by using the “unsubscribe” feature at the bottom of the emails or by requesting cancellation by emailing pcs@portugalclinicalstudies.com.
• Access and update your information: Our Services allow you to update or modify your personal information in your profile settings. For certain fields, you may need to contact your account administrator.
• Deactivate your account: If you wish to stop using our Services, your administrator can deactivate your access or account. Contact your administrator to request account deactivation. If you are an administrator and cannot deactivate an account in the admin settings, contact Customer Support at pcs@portugalclinicalstudies.com.
• Study participants: Generally, clinical study participants should contact the research team directly rather than AICIB. If a participant contacts AICIB directly, we will fulfil all contractual obligations to handle the request but will prioritise redirecting them to the Principal Investigator, to whom we will provide all necessary information to respond to the request.
• Information requests: As a data subject, you have the right to request: (1) the specific personal data we process; (2) the categories of personal data, specifying the exact data involved; (3) the sources of the personal data collected; (4) the categories of personal data shared and recipients, if any; (5) the purposes of processing; (6) the legal basis for processing; (7) retention periods; (8) the legitimate interests of the controller or a third party if applicable; (9) your rights under law; and (10) how to exercise those rights.
• Access: You have the right to receive confirmation about whether and how we process your personal data. You will have access to the personal data and related information about the Services or Products you contracted; we will provide details on this processing; and, in some cases, a copy of your personal data.
• Rectification: You have the right to request correction of inaccurate or incomplete personal data.
• Erasure: The Client has the right to request deletion of personal data associated with their account or Services used when (1) data is no longer necessary for the purposes processed; (2) consent is withdrawn; (3) data has been unlawfully processed; or (4) data must be erased to comply with a legal or judicial obligation. The right to erasure is not absolute and is assessed case-by-case. Deleted data will be removed from active servers and databases but may remain in archives if deletion is impractical or impossible. We may also be required to retain certain personal data to comply with legal obligations, resolve disputes, or defend rights in legal proceedings.
• Restriction of processing: You may restrict processing of your personal data when: (1) accuracy is contested; (2) processing is unlawful but you oppose erasure and request restriction; (3) we no longer need data but you require it for legal claims; or (4) you object to processing pending resolution.
• Objection: You may object to personal data processing unless we demonstrate overriding legitimate grounds or legal grounds. You also have the right to object to direct marketing and secondary processing for scientific research, historical archiving, or statistical purposes unless necessary for public interest tasks.
• Withdrawal of consent: If processing is based on consent, you may withdraw it at any time without affecting prior processing. Upon withdrawal, we will stop processing for the original purpose unless there is overriding legitimate ground or legal claims. Withdrawal of marketing consent does not affect processing necessary for Services.
• Complaints: If you believe your data rights are violated, you may file a complaint with the supervisory authority — the National Data Protection Commission (“CNPD”) — available at www.cnpd.pt or pursue judicial remedies.
• Automated decision-making: We do not use your personal data for automated decision-making (including profiling) that produces legal or significant effects. If such processing occurs, you will be informed and have the right to contest, provide your viewpoint, and request human review.
• Response times: We will confirm receipt of your request within 5 working days and respond within 30 days. We may extend by 30 additional days if the request is complex.
• Excessive requests: Unfounded or excessive requests may incur a reasonable fee or be declined with explanation.
• Verification: We are required by law to verify the identity of the requester to protect data privacy. We may request additional information or deny requests if identity cannot be confirmed.
• Legal representatives: Authorized legal representatives may act on your behalf upon proof of authorization. We may confirm identity directly and deny requests if authorization is doubtful.

How to exercise your rights:

You may contact AICIB through the form available at the “Who We Are” section or via pcs@portugalclinicalstudies.com.

Changes to this Privacy Policy:
We may update this Privacy Policy at any time, at our sole discretion and without prior notice. Any revised Policy will be posted on our Sites and Services. Users should review it periodically. Continued use of the Sites or Services constitutes acceptance of the updated Policy.

Contact us:
If you have questions about this Privacy Policy, contact us at pcs@portugalclinicalstudies.com or by post at Agência de Investigação Clínica e Inovação Biomédica, Rua de Santa Catarina, 1288, 4000-099 Porto, Portugal.

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