Protocol Specific

2009年，在方案办公室管理的研究中，28%的患者参与了研究者发起的研究，包括外部或内部同行评议（图14）。这些数字不包括国家合作小组或药物研究，即使主要研究者可能对研究设计做出了贡献。如前所述，这些研究通常使用研究性药物，可能结合联合治疗模式以及实验室相关性，对总体方案资源产生更大的影响。此外，许多要求提交和持有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。礼宾办工作人员参与了礼宾方案的初步审查和评价，以及与礼宾方案一起使用的数据收集表格的内容和设计。此外，CRC和DM更多地参与当地招募患者进行研究者发起的试验，以及更多地参与协调当地药代动力学分析的生物标本收集。礼宾司负责编制和

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.