一、研究中心稽查管理程序 Site Audit Management Procedure;
二、临床供应商管理程序 Clinical Vendor Management Procedure ;
三、临床体系文件编号及格式管理程序 Clinical System Document Numbering and Formatting Management Procedure;
四、临床试验人员培训管理程序 Training Management Procedure for Clinical Trial Personnel;
五、临床标准操作规程文件的管理程序 Management Procedure for Clinical Standard Operating Procedure Document;
六、质量管理手册管理程序 Quality Management System Manual Procedure;
七、质量保证文件和质量相关沟通的审核管理程序 Review of Quality Assurance Documents and Quality-Related Communications;
八、临床质量问题管理程序 Clinical Quality Issue Mangement Procedure;
九、纠正与预防措施管理程序 Creative Action & Preventive Action Management Procedure;
十、临床质量自检程序 Clinical Quality Internal Inspection Procedure;
十一、协调监管机构在研究中心或供应商视察 Coordinating Regulatory Inspections at an Investigator Site or Vendor Facility;
十二、研究中心关闭访视管理程序 Site Visit Closure Management Procedure;
十三、项目交接管理程序 Project Handover Management Procedure;
十四、研究药物管理程序 Investigational Product Management Procedure;
十五、研究中心可行性调查和选择管理程序 Site Feasibility Investigation and Selection Management Procedure;
十六、GCP机构立项与递交程序 GCP Agency Project-establishment and Delivery Procedure;
十七、伦理委员会审查与递交程序 Ethics Committee Review and Delivery Procedure;
十八、研究中心启动访视管理程序 Site Initiation Visit Management Procedure;
十九、研究中心监查访视管理程序 Site Monitoring Visit Management Procedure;
二十、临床试验主文档管理程序 Management Procedure for Clinical Trial Master File;
二十一、受试者入组和保留管理程序 Subject Enrollment and Retention Management Procedure;
二十二、研究者会议组织管理程序 Investigator Meeting Organization Management Procedure;
二十三、知情同意书的建立、更新和招募广告管理程序 Management Procedure for Informed Consent Form Establishment, Update and Recruitment Advertisement;
二十四、方案偏离管理程序 Protocol Deviation Management Procedure;
二十五、生物样本管理程序 Biological Samples Management Procedure;
二十六、CRA培训管理程序 CRA Training Management Procedure;
二十七、重大突发公共卫生事件临床运行部应急管理程序 Emergency Management Procedure of Clinical Operation Department of Emergent Events of Public Health;
二十八、临床研究项目管理程序 Clinical Study Project Management Procedure;
二十九、临床研究项目预算管理程序 Clinical Research Project Budget Management Procedure;
三十、项目培训管理程序 Project Trail......