A single clinical trial involves many organisations including but not limited to: the hospitals recruiting participants, GP practices, laboratories analysing or reviewing samples, the sponsor, oversight committees and trial management group, national registries, pharmaceutical and biotech companies. It may be necessary to share participant personal (e.g. date of birth) and healthcare information with these parties during the course of the trial in routine communication or when assessing the quality and safety of the trial. The ethically approved trial specific Patient Information Sheet will provide information to participants on the organisations involved in delivering the trial in which they are taking part.
Participants are also advised in the Patient Information Sheet that by taking part in one of our trials that they are agreeing to allow research staff at their hospital and from the CTU to look at their research and medical records; and that it may also be necessary to allow authorised personnel from the sponsor, NHS, regulatory bodies, and occasionally the company to have access to these records. This is to ensure that the trial is being conducted to the highest possible standards.
Participant information may on occasion be shared with researchers running other ethically approved research studies (future research). These researchers may be in the University of Birmingham, the sponsor organisation (if different), or in other universities, NHS organisations or companies involved in healthcare research in this country or abroad. Information is shared in accordance with the CRCTU’s data sharing policy and access to information is strictly controlled. Where possible the information is anonymised before being shared. Participants will not be identified in any way in any report, presentation or publication arising from this future research.
Information on the organisations given access to the personal information of other individuals on whom we hold data and who are involved in the delivery of a clinical trial will be provided in the protocol, where the governance arrangements for the trial are described, and/or on trial specific registration forms.
Occasionally, trials may be inspected or audited by a third party organisation to make sure that the trial has been conducted in accordance with the relevant requirements. This might include, for example, the Medicine and Healthcare products Regulatory Authority (MHRA), NHS Digital or the Information Commissioner’s Office. In these circumstances, data is only shared as is necessary to comply with our legal and regulatory requirements and only for the purposes of the audit.
Within the University, trial data is shared with only those University staff who need access for the purpose of delivering our academic and non-academic services and facilities.
Participant personal data is shared as is necessary, on a considered and confidential basis, with several external organisations which assist the University with processing your information. These organisations act on our behalf in accordance with our instructions and do not process your data for any purpose over and above what we have asked them to do. We make sure we have appropriate contracts in place with them. Sometimes your personal data is processed by these organisations outside the European Economic Area (for example, because they use a cloud-based system with servers based outside the EEA), and if so, we make sure that appropriate safeguards are in place to ensure the confidentiality and security of your personal data.
Outside of the data sharing requirements described above, we do not share personal data with any other third party without the express permission of the data subject or as permitted by data protection law.
Participants are not identified in any report, presentation or publication arising from the trial.