SGS Clinical Pharmacology Unit
SGS data privacy information notice
Pursuant to the EU Regulation n. 679/2016 (hereinafter the “GDPR”), SGS Belgium NV division Health & Nutrition / Health Science (hereinafter the “Company” or “SGS”) - provides the following information on the Company’s processing of its volunteers‘ and (potential) clinical trial participants‘ personal data (hereinafter the “Data”), as listed below.
Further information may be provided where necessary e.g. for specific clinical trials
1. Data controller and contact details
The Company is responsible, as a controller, for collecting and processing the Data in context of its activities as investigational site (hereinafter “CPU”) for the management of its volunteers database for participation to clinical trials including the Data needed for the payment of compensation for participation in a clinical trial.
The Company is acting as a processor on behalf of the Sponsor of a clinical trial when collecting Data in the execution of the clinical trial. These are activities which SGS executes as Contracted Research Organization (hereinafter “CRO”).
If you have any questions or comments about this Notice, please contact us through the online privacy request form available at https://www.sgs.com/en/online-privacy-statement/privacy-request-form.
If you have any questions related to the Data collected during the clinical trial you can contact us. We might forward your question to the Sponsor but we will do that in a pseudonymized manner so that your identity is not revealed to the Sponsor. You can also choose to contact the Sponsor of a clinical trial directly which means that your identify will be known by the Sponsor
2. Categories and types of Data collected and processed
The Data processed by the Company may include:
- For the management of our volunteer database including payment of compensation for participation in a clinical trial:
- contact information (name, home and/or business address, telephone, email addresses); and
- financial details (bank account details).
- personal information (date of birth, nationality, pictures, height and weight, travel distance, gender…);
- living habits (dietary habits, substances use such as alcohol and tobacco, ...);
- employment information (employment at SGS can be an exclusion criterium for a Sponsor);
- Information allowing verification of identity (partial social security numbers or partial identity card numbers)
- medical data (such as general medical history, use of medication)
- race (ethnicity)
- During the execution of a specific clinical trial for a Sponsor:
- All information specified in the protocol of a clinical trial
- All information required for reporting and analyzing a (serious) adverse event during or after a clinical trial.
3. Purpose and legal basis of the processing and nature of the provision of Data
SGS will always process the Data for a specific purpose and will only process the Data which is relevant to achieve that purpose. SGS will process personal data on the following legal basis and for the following purposes:
a) For fulfillment of contractual obligations (Art. 6.1.b of the GDPR).
Data is processed to provide our services in the context of carrying out our contracts or engagements with our volunteers or participants in a clinical trial e.g. for making payments. You can find other details about the purposes of data processing in the relevant contract documents, terms and conditions, ICF, forms or communications
b) In the context of legitimate interests (Art. 6.1.f of the GDPR).Where required and without unduly affecting volunteers and clinical trial participants’ privacy interests or fundamental rights and freedoms, SGS processes the Data for the purposes of SGS legitimate interests pursued directly by SGS or by a Sponsor (data controller in the clinical trial).
These legitimate interests may include:
- Performing our services as CPU or CRO in a clinical trial as specified in the protocol of the Sponsor in the case the Sponsor processes your Data on the basis of legitimate interest.
- Helping SGS to learn more about its volunteers and their experiences with Company by conducting opinion research.
- Assessing legal claims and defending in legal disputes.
- Guaranteeing SGS IT security infrastructure and environment.
c) As a result of your consent (Art. 6.1.a of the GDPR).
Your consent is very important to us and SGS wants to use it as intended by the privacy legislation. SGS does not consider e.g. your agreement to participate in a clinical study as a consent to do anything at all with your personal data. If SGS uses consent, we want to be very specific on what you are consenting for and offer you a free choice to agree or disagree or no longer agree with the specific matters we ask the consent for. If you revoke your consent, SGS will stop processing your personal data for the specific matter.
SGS might process your Data on basis of consent for:
- The management of our volunteer database.
- Contacting you with information on a clinical trial you might be eligible for.
- Performing our services as CPU/ CRO in a clinical trial as specified in the protocol of the Sponsor in the case the Sponsor processes your Data on the basis of consent.
- Sharing information on your participation in a clinical trial with your physician
d) Due to legal obligations (Art. 6.1.c of the GDPR) or in the public interest (Art. 6.1.e of the GDPR).
Furthermore, SGS is subject to various legal obligations, i.e. regulatory and statutory requirements. Purposes of processing include fulfilling control and reporting obligations under fiscal laws or, in certain cases, due to accreditation and / or certification mandatory requirements.
SGS might process your Data on basis of legal obligations or public interest for:
- The compliance with fiscal laws.
- The compliance with the Clinical Trial Regulation (law of 07 May 2004 regarding experiment on the human person).
- Preventing the simultaneous enrolment in multiple clinical trials.
- Reporting (serious) adverse events to the authorities and to the Sponsor during the conduct of the clinical trial. These Data shall be pseudonymized where possible.
- Disclosing data to competent authorities during an inspection.