Research data supporting "Capturing the systemic immune signature of a norovirus infection: an n-of-1 case study within a clinical trial": an adverse event case study from the "Adaptive study of IL-2 dose on regulatory T cells in Type 1 Diabetes (DILT1D) trial".

Supporting data for an adverse event case study, with the index case and controls identified and taken from the “Adaptive study of IL-2 dose on regulatory T cells in Type 1 Diabetes (DILT1D) trial”

The study was approved by the Health Research Authority, National
Research Ethics Service, UK (13/EE/0020) and is registered at the
International Standard Randomised Controlled Trial Number Register
(ISRCTN27852285) and at ClinicalTrials.gov (NCT01827735).
Data available is the anonymised individual-participant-level results aggregated to appear as: Figures (9); Supplementary Figures (3); Supplementary Tables (1) in "Capturing the systemic immune signature of a norovirus infection: an n-of-1 case study within a clinical trial". Additional datasets are available to show which participant(s), and
which variable(s) from which dataset(s) were used to create each
Figure.
The paper describes the course of an adverse event observed in DILT1D,
comparing the index case with other participants receiving similar
(ultra-low) doses of IL-2, followed over the course of 2-3 months.
While the index case is omitted from analyses reported in the main
paper, the controls are not, and therefore there is some overlap with
data available for the main study - see https://www.repository.cam.ac.uk/handle/1810/253110

While all obvious personal identifiers have been stripped from
the individual-participant-level data, a case report cannot be
anonymised sufficiently to be able to put it into the public domain
without risk of participant identification. Therefore, it cannot be hosted by the University of Cambridge research repository, but is instead available on application to the DILT1D Data Access Committee, contacted via [e-mail], and on completion of a Data Access Agreement. The Data Access Committee consists of: the Chief Investigator; the Senior Trial Statistician; and the independent Trial Chair; with additional independent advice from the University of Cambridge School of Clinical Medicine's Information Governance team. Applications will be judged on the following criteria: 1. Has the application been submitted by bona fide researchers? 2. Is the application's purpose in line with the original aims of the trial, and the consents given? 3. Does the application run the risk of producing information that may allow individual trial participants to be identified, or may prejudice the willingness of participants to join future trials? This record will be updated with publication details.

本数据集为一项不良事件（adverse event）案例研究的配套数据，其索引病例与对照样本取自《1型糖尿病中IL-2剂量对调节性T细胞（regulatory T cells）作用的适应性研究（DILT1D）试验》。

本研究已获得英国国民研究伦理服务署（National Research Ethics Service）健康研究管理局（Health Research Authority）批准（审批编号：13/EE/0020），并分别在国际标准随机对照试验注册号注册库（International Standard Randomised Controlled Trial Number Register，ISRCTN27852285）与ClinicalTrials.gov（注册号：NCT01827735）完成注册。

本次公开的匿名化个体参与者水平数据经聚合后呈现为以下形式：论文《捕获诺如病毒感染的全身免疫特征：临床试验内的单病例（n-of-1）案例研究》中的9幅主图、3幅补充图与1张补充表。另有额外数据集用于说明各幅图表的制作所使用的参与者信息、对应数据集内的变量信息。

该论文针对DILT1D试验中观察到的1例不良事件病程进行描述，将该索引病例与其他接受相似（超低）剂量IL-2、随访时长为2至3个月的参与者作为对照进行比较。尽管主论文报告的分析中未纳入该索引病例，但纳入了对照样本，因此与主研究公开数据集存在部分重叠——详细信息可参见https://www.repository.cam.ac.uk/handle/1810/253110。

尽管所有可识别的个人标识均已从个体参与者水平数据中移除，但案例报告无法被充分匿名化，若公开至公共领域仍存在参与者身份被识别的风险。因此，本数据集无法由剑桥大学研究知识库托管，申请者需通过邮箱[e-mail]联系DILT1D数据访问委员会，并签署数据访问协议后方可获取。该委员会由首席研究员、高级试验统计师与独立试验主席组成，另可获得剑桥大学临床医学院信息治理团队的独立咨询意见。

申请将依据以下标准进行审核：1. 申请者是否为合法合规的研究人员？2. 申请用途是否符合试验初始目标与参与者已签署的知情同意书要求？3. 该申请是否存在产生可识别个体试验参与者信息的风险，或损害参与者参与未来试验意愿的风险？本记录将随相关论文的发表信息进行更新。