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Mapping protocol lifecycle with project management methodology for optimizing and aligning resources within clinical research setting

Wednesday, October 26, 2011 — Poster Session III

10:00 a.m. – Noon

Natcher Conference Center




  • J Giri
  • L Lambert
  • J Pierson
  • J Tierney
  • B Baseler


The Regulatory Compliance and Human Subjects Protection Program (RCHSPP) has collaborated with Regulatory Compliance and Human Subjects Protection Branch (RCHSPB), Division of Clinical Research (DCR), NIAID to adapt and implement standard project management methodology for developing resource optimization and forecasting models that enable program management staff to assess current state of resource utilization and forecast future resource requirements within RCHSPB/P. The integrated strategic project management framework combines project management methodology and the protocol lifecycle methodology for streamlining research support processes by aligning budget and labor resources across all functional groups and protocol projects involving domestic and international clinical research sites. The alignment of budget and labor resources with protocol development and regulatory projects enables program management staff with enhancing existing clinical research support processes; monitoring, tracking, and reporting progress; optimizing and aligning resources within and across all functional groups for each lab and/or site involved in the clinical research; and establishing forecast criteria for projecting budget and labor resource requirements for each fiscal year. Participants interested in this poster presentation can gain insight from our team’s experience and be exposed to key steps, tools, and templates for implementing similar methodologies and resource optimization models within their programs or organizations.

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