Protocol Specific

2009年，参加礼宾办公室管理的研究的患者中有28%参与了由研究人员发起的研究，并进行了外部或内部同行评审(图14)。这些数字不包括国家合作小组或药物研究，即使首席研究人员可能对研究设计做出了贡献。如前所述，这些研究经常使用研究药物，并可能包括联合模式治疗以及实验室相关性，对总体方案资源的影响更大。此外，许多人需要提交和持有IND。与合作小组或行业赞助的研究相比，这些研究的临床研究协调员(CRC)和数据经理(DM)的职责范围通常更详细。礼宾处工作人员参与对议定书的初步审查和评价，以及结合议定书使用的数据收集表格的内容和设计。此外，CRC和DM更多地参与研究人员发起的试验的本地患者招募，以及更大程度地参与协调用于本地药代动力学分析的生物谱胺收集。礼宾局汇编和 为便于在为这些研究提供数据和安全监测的L二期委员会会议上介绍，礼宾办公室工作人员负责研究的启动、数据监测、方案修改、研究信息的传播以及安全报告和年度报告的编写。CRC和DM作为一个团队与首席调查员一起，根据联邦法规和指南评估协议和收集的数据的完整性、准确性和协议遵从性。

During 2009, 28% of patients enrolled on studies managed by the Protocol Office participated in investigator-initiated research, with either external or internal peer-review (Figure 14). These figures do not include national cooperative group or pharmaceutical studies, even when the principal investigator may have contributed to study design. As previously noted, these studies often use investigational drugs and may incorporate combined modality therapy as well as laboratory correlates, with a greater impact on overall protocol resources. Additionally, many require filing and holding an IND. The scope of responsibilities for the Clinical Research Coordinator (CRC) and Data Manager (DM) are generally more detailed for these studies in comparison to cooperative group or industry-sponsored studies. Protocol Office staff are involved in the initial review and evaluation of the protocol as well as the content and design of the data collection forms used in conjunction with the protocol. In addition, the CRC and DM are much more involved with the local recruitment of patients for investigator-initiated trials, as well as a greater level of involvement with the coordination of biospecimen collection for local pharmacokinetic analysis. The Protocol Office compiles and tabulates data summary reports, such as toxicity tables, to facilitate presentation at Phase l-ll Committee meetings, which provide data and safety monitoring for these studies, The Protocol Office staff are responsible for study initiation, data monitoring, protocol changes, dissemination of study information, and preparation of safety reports and annual reports. The CRC and DM function as a team in conjunction with the Principal Investigator to evaluate protocols and the data collected for completeness, accuracy, and protocol compliance in accordance with federal regulations and guidelines.