Page 327 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-001
SOP Title: Planning for Recruitment & Retention
5.1.1.3 TL should complete the Feasibility Assessment (see SOP Feasibility Assessment in eBook 2 of 2)
5.1.1.4 TL should do a SLICER DICER to look at the subject for the qualifying patient population (see Learn EPIC for guidance on process)
5.1.1.5 TL should arrange a PI Introductory meeting with the CRC/A to get informed on enrollment goal & methods, subject accommodation, site team and credentials, department resources that will be provided or have been secured, performance site(s), logistics, as well as PI and Co-PIs availability to oversee the study and funding sources.
5.1.1.6Analysis of enrollment demands, resources, feasibility and logistics should be reported to the Director and Senior Director.
5.2 Enrollment Recruitment & Retention: Establishing a Sustainable Enrollment Rate:
5.2.1 Once the analysis feasibility has been completed and a realistic enrollment goal has been established, with a study funding agreement in place, the CRC/A should complete an Advanced Analytics report for screening and/or data pull in order to optimize their enrollment success.
5.2.2 The TL should use the Recruitment Planner to find a sustainable enrollment rate to be enrolled each day, week, month, or year depending on the duration of participation (see tool included at the end of this SOP).
5.2.3 With an established enrollment rate, the CRA/C and TLs should work collaboratively to develop a recruitment plan considering the study coverage, resources available, and logistical constraints. For example, Recruitment is M-F during office hours. CRC 1 will cover days M-W, and CRC 2 will cover days TR-F. Some other considerations are:
Screening Intervals
Restock of study supplies Intervals and processes
Lab and Pharmacy storage capacity, temperature monitoring, and resources
Scheduling of patients
Scheduling notice with ancillary teams (IDS, Laboratory, Access Management, etc)
Reserving & Scheduling Infusion Chairs
PACT Meetings (See SOP PACT Meetings)
Physician Order completion
Study Preparation
EPIC research Billing Review (RBR) (See SOP (EPIC Billing Compliance)
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