Table 2.

Protocol Activity Categories. The staffing model was designed to capture each element of a patient's clinical trial experience, and the effort contributed by clinical research staff to make it happen.

Category	Description
Pre-Screening	Elements that occur prior to consent – medical record review, visit planning, etc.
Screening	Consent and all screening procedures required to ensure eligibility.
Enrolled	Eligibility completion, central confirmations as needed, randomization as needed, enrollment, scheduling for treatment.
Active/On Treatment	Treatment-related items, visit frequency, procedures, etc.
Active/Follow-Up	Visit frequency and procedures. Only used if follow up activities are protocol driven (not standard of care).
Long-Term Follow-Up	Activity required for long-term follow-up.
Data Management	Timelines for entry, average time for case report form (CRF) completion, monitoring and audit frequency, and patient visit frequency.