Consent to access and use routine health data: appropriate wording for participant-facing materials of randomised clinical trials (CrossWord)

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Access to routine health data (from healthcare systems) is one of the key steps that will transform the way clinical trials are done. However, successful access is commonly problematic due to inconsistent guidelines across providers and across time, inconsistent interpretations by trialists, and shifting requirements (e.g., legal framework or provider changes). A key challenge to timely data access is interpretation of wording used in participant-facing trial documents to inform participants of the required consent to access their health data. Appropriate wording will meet the needs of participants, enhance transparency and generate trust in clinical trials research. This studentship aims to review existing wording used in consent for randomised clinical trials, assess users views on this wording and develop new guidance on consent through consensus with a variety of stakeholders and in consultation with regulatory agencies.