出版资料要求

生物arin数据共享请求策略

澳门正规博彩十大排行平台 gives qualified scientific researchers access to patient-level data collected in clinical trials to provide additional opportunities for conducting research that can improve patient care 和 help advance medical science. 应要求并视下文所述情况而定, 澳门正规博彩十大排行平台 will provide access to patient-level data to qualified researchers with a scientifically valid research proposal (which includes their statistical analysis plan) for clinical trial data that has been published in manuscript form on or after January 1, 2019. Data will be made available beginning 6 months 和 ending 2 years after publication in a peer reviewed journal. 因为尊重病人隐私是头等大事, all necessary measures are taken to ensure that privacy is safeguarded.

Certain circumstances may prevent 澳门正规博彩十大排行平台 from fulfilling data requests. 这些情况可能涉及:

• 匿名化处理异常困难的临床数据, 有重新鉴定的合理可能性(例如.g., 小型研究, 单中心研究, 研究因缺乏入组而提前终止, 罕见病的临床研究, or studies for which data does not exist in a format that can be readily anonymized), or there is a reasonable likelihood of otherwise violating the privacy rights of individuals;
• 已收集的临床数据受法律约束, 监管, 合同, or consent provisions or considerations that prevent transfer to third parties;
• Locally administered studies in which data 和 results are only available in languages other than English;
• Case narratives, documentation for adjudication, imaging data (e.g.、x光、核磁共振扫描等.), genetic data, 和 exploratory biomarker data; or
• Substantial practical constraints to providing technical data access (e.g.(无法找到文件的较旧的、未电子化的数据).
• Any request for data associated with any ongoing development program unless made six (6) months or later following approval of the relevant product;
• 或非商业、学术目的以外的任何请求.

澳门正规博彩十大排行平台在哪里有合作研究, 共同发展, or co-marketing/co-promotion agreement or where the product has been out-licensed, it is recognized that the responsibility for disclosure may be dependent on the agreement between 澳门正规博彩十大排行平台 和 another party or parties. 在这种情况下, 澳门正规博彩十大排行平台 will make reasonable efforts to gain agreement to share data in response to requests.

Researchers seeking access to patient-level data or other information such as clinical study reports are required to enter into a Data Access Agreement committing the applicant to use the data only for the stated research purposes 和 not to disclose the data to third parties.