Thomas, Kathleen M
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Publication An Organizational Diagnosis Of A Centralized Investigational New Drug Core Within A Large Academic Health Center(2012-11-18) Thomas, Kathleen MThis capstone examines the root cause of the ineffectiveness of a centralized Investigational New Drug (IND) core within a research department of a large Academic Health Center (AHC). This capstone utilized an organizational diagnosis approach to collect data to determine what is and is not contributing to the success of the core. The hypotheses of this study are: 1) The centralized model was set in place without clear objectives; 2) The IND core is not operating in the way it was structured to operate; 3) The IND core is understaffed and unable to fully carry out the level of responsibility associated with being a Sponsor; and 4) Future expansion was not included in the planning phase. Data was collected by interviewing staff members, and participant observations. Prior to conducting the current state interviews, I conducted background interviews with previous staff members to determine the rationale behind centralization. The results supported the importance of learning an organization's history prior to implementing a change, as well as the need for group development prior to the implementation of a new model within an organization. The organizational diagnosis I conducted was able to confirm three of four of the hypotheses. I was able to uncover two variables that I did not consider before the diagnosis: role definition, and inter-group dynamics.