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STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-001
SOP Title: Planning for Recruitment & Retention
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline some resources and tactics for planning for recruitment and retention of subjects on clinical research trials at Children’s Health system of Texas (CHST).
2. INTRODUCTION
As part of the effort to serve our mission of making children’s lives better through the advancement of medical treat, Research Administration (RA) has developed innovative approaches and avenues for supporting sustainable, and viable enrollment of patients on clinical trials.
3. SCOPE
This SOP pertains to all those who conduct human subjects research at CHST.
4. RESPONSIBILITIES
4.1 Assessing Feasibility: Establishing a Feasible Enrollment Goal:
Clinical Research Associates (CRA) and Coordinators (CRC) should work with their Team Leads (TL) to: assess feasibility and logistics toward the stated the stated enrollment goals within the enrollment period set forth by their Principal Investigator (PI) and sponsor. This feasibility can be facilitated by puling aggregate numbers from SLICER DICER or an Advanced Analytics feasibility/screening report to help estimate a realistic enrollment goal. It can further be informed by the amount of required staff time, equipment, space and logistics.
4.2 Enrollment Recruitment & Retention: Establishing a Sustainable Enrollment Rate:
CRA/C and TLs should assess their study to identify the appropriate resources that will support enrollment. For example, if a study has a high enrollment number or stringent inclusion and exclusion criteria, an Advanced Analytics Screening report can be considered to help identify potentially qualifying patients. Another important consideration is the availability and capacity of staff, equipment, space, and logistics to establish a sustainable enrollment rate in support of retention.
5. SPECIFIC PROCEDURE
5.1 Assessing Feasibility: Establishing a Feasible Enrollment Goal:
5.1.1 Upon receiving a new study, the CRA/C and TLs should work collaboratively to:
5.1.1.1 Complete a Coordinator Time Sheet (CTS) (see SOP Securing Reimbursement for Research Study)
5.1.1.2 Complete the Lab feasibility Questionnaire (See SOP Laboratory Initiation)
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