Study Startup
Section 2
Implementation Readiness Checklist
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 (including DUAs if applicable) | |
| 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 extracting and harmonizing 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 and recorded | |
| Budget is realistic, feasible, and accounts for potential changes |
|
| Trial registration is updated to reflect any changes to study protocol (including changes to outcome measures and analytic plan) | |
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