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.

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