Implementation Readiness Checklist

Study Startup

Section 2

Implementation Readiness Checklist

Contributors

Lynn L. DeBar, PhD, MPH
Jeffrey G. Jarvik, MD, MPH
Leah Tuzzio, MPH
Miguel A. Vazquez, MD

 

Contributing Editor

Liz Wing, MA

The checklist below identifies milestones that mark trial readiness.

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Milestone Completed
Recruitment plans are finalized
All sites identified (documentation of site commitment)
Methods for accurately identifying participants validated
All agreements for necessary subcontracts in place
Ethical/regulatory aspects are addressed
Coordinated IRB oversight in place
Finalized plans for informed consent or waiver of informed consent
Finalized data and safety monitoring plan
Intervention is fully developed and finalized
Finalized intervention (including materials and training at sites) ready for site implementation
Finalized protocol is IRB approved (informed consent and data collection forms, if applicable)
Data collection methods are adequately tested  
Validated methods for the electronic health record information
Validated study surveys, interviews, or other data collection modes
Demonstrated quality assurance and harmonization of data elements across healthcare systems/sites
Statistical and data analysis methods have been adequately developed
Budget is realistic and feasible

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Implementation Readiness Checklist

Citation:

DeBar LL, Jarvik JG, Tuzzio L, Vazquez MA. Study Startup: Implementation Readiness Checklist. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://rethinkingclinicaltrials.org/startup/startup-implementation/. Updated September 14, 2017.