Performance Improvement 2008. How Evaluate Whether Standard Policies and Procedures Improve Compliance with the Requirements in Sponsored Clinical Research?


This feasibility study identified evaluation methodologies, techniques, and tools to measure the implementation of the standardized policies and procedures for the Division of AIDS programs sponsored clinical research. This study developed how to documented processes related to dissemination, implementation and training and evaluation questions focused on short- term outcomes among target audiences (NIAID Project Officers and Division of AIDS-funded researchers). The National Institute of Allergy and Infectious Diseases restructured its HIV/AIDS clinical trials networks to create a more integrated, collaborative and flexible research structure. The Institute formalized and developed a standardized set of policies and procedures to be used by Division of AIDS staff, extramural researchers, institutions, and other stakeholders when planning and implementing clinical research. The overarching goal of the policies and procedures is to facilitate clinical research.

Areas identified as essential to assess implementation and impact included: awareness and accessibility of newly developed policies and procedures; understanding and applicability of the policies and procedures; and clarification of whether the policies and procedures facilitate the harmonization of Division of AIDS funded clinical research programs. There have been no systemic assessments of the impact of policies and procedures on clinical research and organizational functioning. The proposed evaluation of newly implemented policies and procedures should make a significant contribution to the existing knowledge in this area and provide information on how to improve the implementation of policies and procedures for conducting clinical research.

Report Title: Feasibility Study of Optimal Approaches for Evaluating the Implementation of NIAID Division of AIDS-wide Standardized Clinical Policies and Procedures. Report may be obtained from Federal Contact
Agency Sponsor: NIH, National Institutes of Health
Federal Contact:
Richard Hafner, MD, 301-435-3766
NOVA Research Company

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"PerformanceImprovement2008.pdf" (pdf, 1.29Mb)

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