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.
| 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 | |
SECTIONS
CHAPTER SECTIONS