ISO 14155 6.7 Subject privacy and confidentiality of data: Confidentiality of data shall be observed by all parties involved at all times throughout the clinical investigation. All data shall be secured against unauthorized access. The principal investigator or institution shall provide direct access to source data during and after the clinical investigation for monitoring, audits, EC review and regulatory authority inspections. 受试者隐私和保密信息出现在医院的医疗记录和试验原始文件中，符合医疗、GCP和当地法律法规的要求。如受试者隐私和保密信息被传递至医院外和/或由申办者获得（除了在院内进行的监查，稽查和检查外），存在受试者隐私和保密信息泄露的情况/风险。该案例中可考虑由申办者授权的工程师在医院内进行受试者影像片的审阅，该工程师需要签署保密协议，获得院方和研究者的同意；或者通过技术手段实现遮蔽掉受试者隐私和保密信息后再传输影像进行远程审阅。以上两种方式均需要得到受试者相应的知情同意。