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Project Management in Clinical Research: How It Informs the Decision Making Process

Thursday, October 11, 2012 — Poster Session IV

2:00 p.m. – 4:00 p.m.

Natcher Conference Center, Building 45




  • J. Giri
  • C.K. Osborne
  • L. Lambert
  • J. Tierney
  • J. Pierson
  • B. Baseler


Managing clinical research studies continues to be a complex effort compounded by the current budget climate. Planning for new studies, maintaining ongoing studies and accelerating operational performance with static resources is a significant challenge faced by the Regulatory Compliance & Human Subjects Protection Program (RCHSPP) and Regulatory Compliance & Human Subjects Protection Branch (RCHSPB), Division of Clinical Research (DCR), NIAID. Understanding unique characteristics of clinical studies at various phases of the Protocol Project Management Lifecycle and how these factors influence resource utilization is essential to program sustainability and capacity building. Using the Integrated Strategic Project Management Framework (ISPMF), program budget and labor resources are analyzed to develop insight into the protocol complexities of each service-offering model. Resource utilization reports allow for visibility into the service-offering models and provide data to inform the decision making process. This poster builds on the ISPMF and its concepts to examine the complex nature of managing clinical research studies. Participants interested in this poster presentation can gain insight from the RCHSPP/B’s experience and be exposed to the ISPMF that combines project management and the protocol lifecycle methodologies to create a robust framework to examine resource utilization for projecting resource requirements of any organization.

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