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

获取常规健康数据(来自医疗保健系统)是改变临床试验进行方式的关键步骤之一。然而，由于不同提供商和不同时间的指导方针不一致，试验者的解释不一致，以及要求的变化(例如，法律框架或提供商的变化)，成功的访问通常是有问题的。及时获取数据的一个关键挑战是解释面向参与者的试验文件中使用的措辞，以告知参与者获取其健康数据所需的同意。适当的措辞将满足参与者的需求，提高透明度，并产生对临床试验研究的信任。该项目旨在审查随机临床试验同意中使用的现有措辞，评估用户对该措辞的意见，并通过与各种利益相关者的共识并与监管机构协商，制定关于同意的新指南。

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.