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Process Workflow-Identifying Bottlenecks

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Submitted By rsecreto408
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Process Workflow-Bottlenecks
April 23, 2013

Process Workflow-Bottlenecks

The bottleneck that I have identified in this process workflow during site initiation process is the time period for when the study will be approved by Institutional Review Board (IRB). The IRB is the regulatory agency that reviews the conduct of the study to ensure the safety and wellbeing of the subject participants during the course of the study. If the approval from the IRB is not obtained, the study or clinical trial cannot begin. Although other activities can be performed in parallel while awaiting IRB approval, the most critical step in site activation such as when the clinical site can begin enrollment will be put on hold if the IRB has not approved the study.
Time and money are at stake when there is a delay in site activation. The longer it takes for the site to begin enrollment, the longer it will take for the Sponsor to obtain data from the site. In addition, resources that are allocated for the study are being underutilized as the study awaits approval from the IRB. The down fall in longer approval time from the IRB is that some sites do lose interest or they would have a change in staff that would require the Sponsor to conduct additional training once the site receives IRB approval. Timing of when the other activities such as supply shipments and trainings are all dependent on when the IRB approves the study.

Reference
Chase, R. B., Jacobs, F. R., & Aquilano, N. J. (2006). Operations management for competitive advantage (11th ed.). New York, NY: McGraw Hill/Irwin.

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