25 May 2018 marks the start of enforcement of the European Union’s General Data Protection Regulation. This new piece of legislation has had a great impact on anyone whose business involves handling personal data about EU residents or within the EU. Naturally, personal data is a part of research and clinical trials, so we have been busy to make sure that we are compliant.


This article provides an overview of the data-related roles and responsibilities when you’ve chosen Clinical Studio as your research platform and will explain Clinical Studio’s efforts to live up to the values and requirements of the GDPR.


Clinical Studio as the data processor

The people you store in Clinical Studio as Users and Subjects are your data subjects, and you are considered the data controller for this personal data. In our Terms of Service and Privacy Policy, we refer to this data as Client Data. 


Using the Clinical Studio system and products to manage your users and study subjects means that you have engaged Clinical Studio as a data processor to carry out certain processing activities on your behalf.

According to Article 28 of the GDPR, the relationship between the controller and the processor needs to be made in writing (electronic form is acceptable under subsection (9) of the same Article). This is where our Terms of Service and Privacy Policy come in. These two documents also serve as your data processing contract, setting out the instructions that you are giving to Clinical Studio with regard to processing the personal data you control and establishing the rights and responsibilities of both parties. Clinical Studio will only process your Client Data based on your instructions as the data controller.


Hopefully, this helps you to better navigate the EU’s data protection requirements. If you have any questions with regard to the above, you’re welcome to reach out to us at dpo@clinicalstudio.com and we’ll do our best to explain things further.


Clinical Studio as the data controller

Additionally, Clinical Studio acts as the data controller for the personal data we collect about the primary account Administrator, the user of our web app, mobile apps, and website.

First and foremost, we process data that is necessary for us to perform our contract with you (GDPR Article 6(1)(b)).

Secondly, we process data to meet our obligations under the law (GDPR Article 6(1)(c)) — this primarily involves financial data and information that we need to meet our accountability obligations under the GDPR.

Thirdly, we process your personal data for our legitimate interests in line with GDPR Article 6(1)(f).


What are these ‘legitimate interests’ we talk about?

  • Improving the app and website to help provide you a more powerful research data collection tool.
  • Making sure that your data and Clinical Studio’s systems are safe and secure.
  • Responsible marketing of our product and its features.


As the controller for your personal data, Clinical Studio is committed to respecting all your rights under the GDPR. If you have any questions or feedback, please reach out to our Data Protection Officer by email at dpo@clsds.com.


What is Clinical Studio doing for the GDPR

As a company with users in Europe and around the globe, Clinical Studio is very much up to speed with the implications that the EU General Data Protection Regulation has for businesses.

We appreciate the privacy needs of Clinical Studio users, as well as underlying subjects, and have implemented — and will continue to improve — technical and organizational measures in line with the GDPR to safeguard the personal data processed by Clinical Studio.


Internal processes, security and data transfers

A large part of GDPR compliance is making sure that there are procedures in place that ensure that data processes are mapped and audit-able. We have added elements to our application development cycle to build features in accordance with the principles of Privacy by Design. Any access to the Client Data that we process on your behalf is strictly limited. Our internal procedures and logs make sure that we meet the GDPR accountability requirements in this regard.


We have established a process for onboarding third-party service providers and adopting tools that makes sure that these third-parties meet the high expectations that Clinical Studio and its customers have when it comes to privacy and security. We have further launched a data center in Europe to store the databases of EU customers to improve performance and provide additional assurance that your data enjoys the level of protection envisioned by the GDPR.


Readiness to comply with subject access requests

Data subjects’ ownership of their personal data is at the heart of the GDPR. We have created a readiness to respond to data subject requests to delete, modify, or transfer their data. This means that our Customer Support Specialists along with the Engineers that assist them in their work are well-prepared to help you in any matters involving your personal data, in addition to providing the awesome customer support experience that you are accustomed to.


Documentation

Our Terms of Service and Privacy Policy are constantly being revised to increase transparency and to make sure the documents meet GDPR requirements. As these are the basis for our relationship for you, it is very important for us to comprehensively and openly explain our commitments and your rights in these documents. Additionally, we’re constantly mapping all our data processing activities to be able to comply with the GDPR accountability requirements.


Training

All of the above is supported by extensive training efforts within the company so that the GDPR compliant processes we’ve put in place are followed. Sessions on data privacy and security are an integral part of our onboarding process and each department receives training that is tailored to their work involving personal data.


Clinical Studio is firmly convinced that meeting GDPR requirements is much more than just checking off boxes in a list. For us, the GDPR is truly a lifestyle of respect to individuals’ privacy and responsibility in handling personal data.