Table 1.

Site readiness practices that promote clinical trial site readiness through diversity, equity, inclusion, and access

Site readiness practice	Reference domain
Diversifying participants	Research Team – Site Readiness Practice 1
The research team has sufficient and diverse personnel, to support the roles and functions needed to conduct a clinical trial and enroll trial participants who accurately reflect the patient population for the disease or condition being studied, with particular consideration for underrepresented and underserved groups.
Diversifying and sustaining research teams and workforce	Infrastructure – Site Readiness Practice 11
Ensure sufficient processes for hiring and supporting diverse staff to fulfill the roles and functions needed to conduct a clinical trial (e.g., principal/subinvestigators, clinical research associates, research nurses, data managers, and study coordinators).
Emphasizing accountability in trial recruitment and retention	Study Management – Site Readiness Practice 4
Research team has access to and process for recruiting and retaining eligible study participants, which should include a plan for enrolling adequate numbers of participants from populations that are underrepresented and underserved in clinical trials.
Protecting trial participants	Ethics and Safety – Site Readiness Practice 1
Research team can protect the rights and welfare of trial participants pursuant to national, state, local, and other applicable requirements and study protocol.
Reducing bias through data privacy and transparency	Data Collection and Management – Site Readiness Practice 5
Research team can ensure blinding/masking, while promoting transparency and trust with study participants regarding how their data will be used and who will have access to it.