Core--Clinical research support

描述：（申请人描述）UPCI临床研究服务提供以下中心资源：(1)协助主要研究者撰写方案、构建同意书和制定方案摘要；(2)向UPCI方案审查委员会、机构审查委员会（IRB）和一般临床研究中心（GCRC）咨询委员会提交方案；(3)向FDA提交研究者IND申请；(4)为所有UPCI临床试验提供数据管理和协调；(5)监督外部审稿人的现场访问和审核；(6)评估UPCI推荐的新研究患者的可用性；(7)评估与新研究相关的临床研究成本；(8)协助主要研究人员为外部支持的试验制定研发预算。这个中央UPCI资源为所有UPCI临床研究的开发、实施和监督提供了基础设施。

Description: (Applicant's Description) UPCI Clinical Research Services provides the central resource for (1) assisting, principal investigators in protocol composition, consent form construction and protocol summary development; (2) submission of protocols to UPCI Protocol Review Committee, Institutional Review Board (IRB) and General Clinical Research Center (GCRC) Advisory Committee; (3) submitting investigator IND applications to FDA; (4) providing data management and coordinator for all UPCI clinical trials, (5) overseeing external reviewers site visits and audits; (6) assessing UPCI recommended patient availability for new studies; (7) evaluating clinical research costs associated with new studies and (8) assisting principal investigators in research development budgets for externally supported trials. This central UPCI resource provides the infrastructure for development, conduct, and oversight of all UPCI clinical research studies.