The resource below was developed by the Privacy Methodology for Data Sharing Initiative in an effort to promote greater transparency for clinical trial participants about the privacy safeguards applied to data provided for reuse, to ensure improved data utility while safeguarding data privacy of trial participants.
In 2020, TransCelerate published a framework to help companies address privacy questions related to clinical trial participant data and increase the potential reuse of clinical data. An increase in data reuse reduces the burden on patients, with less data needing to be collected as the use of existing data is maximized. In addition to the framework paper, entitled, “A Privacy Framework for Clinical Data Reuse: Secondary Data Use in the Pharmaceutical Industry” you can also view tools and an overview video on the TransCelerate website here. The TransCelerate Privacy team is currently building upon this framework through the development of a Privacy Methodology Toolkit for Clinical Data Reuse that identifies approaches to implement privacy safeguards for relevant variable types, along with logic and transparency mechanisms, to ensure data protection as well as maximized data utility.
This educational toolkit can be used by study sponsors to help clinical trial participants better understand the data protection measures that will be applied to their personal data. To increase user friendliness, technical terminology, such as ‘anonymization’ or ‘pseudonymization’, and how this relates to the protection of personal data, is avoided. The toolkit includes two key elements:
- Educational Tool: Download PDF and PowerPoint. The editable educational tool will provide a visual, consistent, succinct, easy-to-understand breakdown for the clinical trial participant outlining how patient privacy is protected by study sponsors. The tool can be edited by a sponsor as necessary to reflect the process it uses.
- Supporting Document & FAQ: Download Word Doc. The supporting document provides important context about the educational tool and can aid study sponsors in answering common questions asked by IRBs and Ethics Committees.
This educational toolkit may be useful to several study sponsors roles including Trial Managers (who prepare the Informed Consent Form being provided to trial participants) as well as legal or data protection roles (that review Informed Consent language).