Celleron Therapeutics Ltd is committed to ensuring the appropriate processing of personal data. We have procedures for obtaining consent, maintaining security, controlling data use, retention periods, and giving accountability.
Why does Celleron Therapeutics need to collect and store personal data?
In order to research the safety and effectiveness of new anti-cancer precision medicines and associated diagnostics, Celleron Therapeutics needs to conduct clinical trials, and report these to government authorities such as the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Clinical trials involve the collection and processing of health-related personal data such as clinical examinations, laboratory results, ECGs, and CT scan images for example. Celleron Therapeutics is committed to ensuring the privacy of patients participating in clinical trials. We do this by following procedures which are compliant with the EU’s General Data Protection Regulation (GDPR). The main principles of this are that we obtain written patient consent for collection, verification, and analysis of study-related personal information; that the information we collect and use is appropriate for this purpose, does not constitute an invasion of privacy, is held in a secure manner, and retained only for as long as absolutely necessary.
Can I Be Identified in Clinical Trial Data?
Under the EU’s General Data Protection Regulation (GDPR) personal data is defined as:
“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”.
Celleron Therapeutics will not collect any information which immediately identifies a clinical trial patient. Data will be assigned a sequential anonymous code number for analysis purposes. Basic demographics such as year of age, sex, height, weight, and disease diagnosis will be recorded however.
The only institution with immediate access to identifiable personal data will be the clinic at which you as the trial patient are being cared for.
How will Celleron Therapeutics use the information it collects about me?
Safety data from the clinical trial will be continuously reviewed and reported to governments when necessary, to develop a scientific awareness of any health risks that may be emergent in relation to the test treatment.
At the end of the study, the anonymised data will be grouped with that from other study patients into electronic datasets, and statistically analysed to evaluate the safety and /or effectiveness of the treatment. These results will then be written into a formal report, a synopsis of which will be posted on a public website.
Manual and automated quality checks will be used throughout, to ensure the reported results are error-free.
Will Celleron Therapeutics share my personal data with anyone else?
Celleron Therapeutics may pass the clinical trial data on to a service provider(s) contracted to provide specialist functions eg project management, safety monitoring, statistical analysis, report writing etc. Any service providers that we may share your data with are contractually obliged to follow the GDPR, keeping your clinical trial data securely, and to use it only to for the specified clinical trial. When they no longer need your data to fulfil this service, they will dispose of the details in line with Celleron Therapeutics’s procedures. If we wish to pass your data onto a third party we will only do so once we have obtained your consent, unless we are legally required to do otherwise.
How long will Celleron Therapeutics store the personal data it collects about me?
Celleron Therapeutics will process your clinical trial information in a manner compatible with the GDPR. We not keep it for longer than is necessary. Celleron Therapeutics is required to retain information in accordance with the laws relating to clinical trials. This may be for up to 25 years.
Can I find out the personal data that the organisation holds about me?
If you have participated in a Celleron Therapeutics clinical trial: at your request, we can confirm what information we hold about you and how it is processed (Subject Access Request). You will be asked to provide a copy of your passport to confirm identity. If Celleron Therapeutics does hold personal data about you, you can request the following information:
- Identity and the contact details of the person or organisation that has determined how and why to process your data. In some cases, this will be a representative in the EU.
- Contact details of the Data Protection Officer, where applicable.
- The purpose of the processing as well as the legal basis for processing.
- If the processing is based on the legitimate interests of Celleron Therapeutics or a third party, information about those interests.
- The categories of personal data collected, stored and processed.
- Recipient(s) or categories of recipients that the data is/will be disclosed to.
- If we intend to transfer the personal data to a third country or international organisation, information about how we ensure this is done securely. The EU has approved sending personal data to some countries because they meet a minimum standard of data protection. In other cases, we will ensure there are specific measures in place to secure your information.
- How long the data will be stored.
- Details of your rights to correct, erase, restrict or object to such processing.
- Information about your right to withdraw consent at any time.
- How to lodge a complaint with the Supervisory Authority.
- Whether the provision of personal data is a statutory or contractual requirement, or a requirement necessary to enter into a contract, as well as whether you are obliged to provide the personal data and the possible consequences of failing to provide such data.
- The source of personal data if it wasn’t collected directly from you.
- Any details and information of automated processing, and any meaningful information about the logic involved, as well as the significance and expected consequences of such processing.
To make a Subject Access Request, please contact:
The Data Protection Officer
Celleron Therapeutics Ltd
Magdalen Centre, Robert Robinson Avenue
Oxford Science Park
Oxford OX4 4GA
Tel: 01865 784330