Florence Library of GDPR and Clinical Trials Resources

In May 2018, the General Data Protection Regulation (GDPR) was enforced across the European Union after being approved by the European Parliament two years prior. This legislation changed the way personal data could be collected, stored, and used across industries.

In response, regulatory bodies around the globe have created and published information to help the Clinical Trial Industry navigate data protection – which includes data privacy and security. The information on this page stem mainly from these documents:

So where does Florence fit?

Florence is the leading platform for remote connectivity and electronic document workflow management in clinical research. Our operations, practices, policies, and software all align with global data governance and regulatory standards. As a controller, processor, and trusted industry software vendor, Florence has extensive privacy and security controls in place, along with a dedicated data protection team that ensures our data privacy and security standards are at the highest level. You can learn more about our data protection programs here.

At Florence, one way we give back to the clinical research community is through sharing educational resources to ease digital transformation in clinical trials. This resource library was created to help educate the community on GDPR and it’s role in clinical research.

The information presented in our library is for informational purposes only, they are not for implementation in operations. Please consult official GDPR guidance documents for operational use.

Download the Beginner’s Guide to GDPR for Clinical Trials

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Download Beginner’s Guide to GDPR for Clinical Trials

GDPR and Clinical Trials Questions and Answers

The following Q&A section is from the document titled, “Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation” was gathered from the European Commission Directorate-General For Health And Food Safety. You can find the original document here. The numbers of the questions below correspond to their placement in the original document.

Personal Data

Q1. What are the general obligations of the Clinical Trials Regulation with regard to personal data?  [See Answer]

Q7. What is the meaning of Article 28(2) of the CTR and what are the implications for the use of personal data outside the protocol of the clinical trial (secondary use) within the scope of the GDPR? [See Answer]

Q8. Processing of personal data in the context of emergency clinical trials (Article 35 of the CTR) [See Answer]

Legal Basis

Q2. Who is responsible for determining the correct legal basis for personal data processing in the context of clinical trial? [See Answer]

Q3. What is the legal basis for the processing of personal data of clinical trial subjects in the context of clinical trials (primary use) carried out in accordance with the Clinical Trial Regulation? [See Answer]

Consent

Q4. What is the difference between informed consent within the meaning of the clinical trial Regulation and consent within the meaning of the GDPR? [See Answer]

Q6. What are the legal consequences of withdrawal of the consent for participation in the clinical trial under the Clinical Trial Regulation? [See Answer]

Information Sharing

Q5. How to understand the requirements of the GDPR regarding information that should be given to subjects participating in a clinical trial? [See Answer]

Q10. What rules apply to the data transfers outside the EU? [See Answer]

Sponsors

Q9. Is a sponsor established in [a] third country subject to EU data protection rules? [See Answer]

Q11. How should a sponsor proceed in the case of clinical trials authorised under the Clinical trials Directive? [See Answer]

Download Beginner’s Guide to GDPR for Clinical Trials

GDPR Definitions

Personal Data:

Any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person. Download the Beginner’s Guide to GDPR with all definitions, and questions and answers.

Processing:

Any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction. Download the Beginner’s Guide to GDPR with all definitions, and questions and answers.

Restriction of Processing:

The marking of stored personal data with the aim of limiting their processing in the future. Download the Beginner’s Guide to GDPR with all definitions, and questions and answers.

Profiling: 

Any form of automated processing of personal data consisting of the use of personal data to evaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning that natural person’s performance at work, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements. Download the Beginner’s Guide to GDPR with all definitions, and questions and answers.

Pseudonymisation:

The processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person. Download the Beginner’s Guide to GDPR with all definitions and questions.

Filing System:

Any structured set of personal data which are accessible according to specific criteria, whether centralised, decentralised or dispersed on a functional or geographical basis. Download the Beginner’s Guide to GDPR with all definitions and questions.

Controller:

The natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State law. Download the Beginner’s Guide to GDPR with all definitions and questions.

Processor:

A natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller. Download the Beginner’s Guide to GDPR with all definitions and questions.

Recipient:

A natural or legal person, public authority, agency or another body, to which the personal data are disclosed, whether a third party or not.2 However, public authorities which may receive personal data in the framework of a particular inquiry in accordance with Union or Member State law shall not be regarded as recipients; the processing of those data by those public authorities shall be in compliance with the applicable data protection rules according to the purposes of the processing. Download the Beginner’s Guide to GDPR with all definitions and questions.

Third Party:

A natural or legal person, public authority, agency or body other than the data subject, controller, processor and persons who, under the direct authority of the controller or processor, are authorised to process personal data. Download the Beginner’s Guide to GDPR with all definitions and questions.

Of the data subject means any freely given, specific, informed and unambiguous indication of the data subject’s wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her. Download the Beginner’s Guide to GDPR with all definitions and questions.

Personal Data Breach:

A breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed. Download the Beginner’s Guide to GDPR with all definitions and questions.

Genetic Data:

Personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question. Download the Beginner’s Guide to GDPR with all definitions and questions.

Biometric Data:

Personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, which allow or confirm the unique identification of that natural person, such as facial images or dactyloscopic data. Download the Beginner’s Guide to GDPR with all definitions and questions.

Data Concerning Health:

Personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status. Download the Beginner’s Guide to GDPR with all definitions and questions.

Main Establishment:

(a) As regards a controller with establishments in more than one Member State, the place of its central administration in the Union, unless the decisions on the purposes and means of the processing of personal data are taken in another establishment of the controller in the Union and the latter establishment has the power to have such decisions implemented, in which case the establishment having taken such decisions is to be considered to be the main establishment.

(b) As regards a processor with establishments in more than one Member State, the place of its central administration in the Union, or, if the processor has no central administration in the Union, the establishment of the processor in the Union where the main processing activities in the context of the activities of an establishment of the processor take place to the extent that the processor is subject to specific obligations under this Regulation.

Download the Beginner’s Guide to GDPR with all definitions and questions.

Representative:

A natural or legal person established in the Union who, designated by the controller or processor in writing pursuant to Article 27, represents the controller or processor with regard to their respective obligations under this Regulation. Download the Beginner’s Guide to GDPR with all definitions and questions.

Enterprise:

A natural or legal person engaged in an economic activity, irrespective of its legal form, including partnerships or associations regularly engaged in an economic activity. Download the Beginners Guide to GDPR with all definitions and questions.

Group of Undertakings:

A controlling undertaking and its controlled undertakings. Download the Beginner’s Guide to GDPR with all definitions and questions.

Binding Corporate Rule:

Personal data protection policies which are adhered to by a controller or processor established on the territory of a Member State for transfers or a set of transfers of personal data to a controller or processor in one or more third countries within a group of undertakings, or group of enterprises engaged in a joint economic activity. Download the Beginner’s Guide to GDPR with all definitions and questions.

Supervisory Authority:

Means an independent public authority which is established by a Member State pursuant to Article 51. Download the Beginner’s Guide to GDPR with all definitions and questions.

Supervisory Authority Concerned:

(a) The controller or processor is established on the territory of the Member State of that supervisory authority;

(b) Data subjects residing in the Member State of that supervisory authority are substantially affected or likely to be substantially affected by the processing; or

(c) A complaint has been lodged with that supervisory authority.

Download the Beginner’s Guide to GDPR with all definitions and questions.

Cross-Border Processing:

a) Processing of personal data which takes place in the context of the activities of establishments in more than one Member State of a controller or processor in the Union where the controller or processor is established in more than one Member State; or

b) Processing of personal data which takes place in the context of the activities of a single establishment of a controller or processor in the Union but which substantially affects or is likely to substantially affect data subjects in more than one Member State.

Download the Beginner’s Guide to GDPR with all definitions and questions.

Relevant and Reasoned Objection:

Objection to a draft decision as to whether there is an infringement of this Regulation, or whether envisaged action in relation to the controller or processor complies with this Regulation, which clearly demonstrates the significance of the risks posed by the draft decision as regards the fundamental rights and freedoms of data subjects and, where applicable, the free flow of personal data within the Union. Download the Beginner’s Guide to GDPR with all definitions and questions.

Information Society Service:

A service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council (¹) Download the Beginner’s Guide to GDPR with all definitions and questions.

International Organisation:

An organisation and its subordinate bodies governed by public international law, or any other body which is set up by, or on the basis of, an agreement between two or more countries. Download the Beginner’s Guide to GDPR with all definitions and questions.

Download Beginner’s Guide to GDPR for Clinical Trials

Additional Data Protection Resources