Page 45 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-002 SOP Title: Study Assignments & Productivity
1. PURPOSE
The purpose of the current standard operating procedure (SOP) is to 1) define the primary clinical research coordinator (CRCs) or associate (CRA) of Research Administration (RA) role in ensuring continuity of care for their patients and research studies, and 2) ensure that study assignments, coverage plans, and transitions plans can be made in a timely a accurate way as informed by Monthly productivity reporting in the Monthly Report.
2. INTRODUCTION
The well-being of every patient and success of any study is paramount in RA. In effort to ensure this primary focus and to facilitate work-life balance among the CRCs and CRAs, the team leads along with the advisement of the director will work with the research team to devise study coverage plans complete with back-up support, as well as transitionary (e.g., promotion, reassignment contracting), or temporary leave (e.g., FMLA). A back-up CRC or CRA is one who has full access to the study and its functions, as well as full knowledge and capability to conduct the study in the absence of the primary CRC or CRA. The back-up is selected based on their experience, skills and experience qualifications, and the workload analysis from the Monthly Report and CRWT analysis.
The Monthly Report captures several important elements for measuring productivity toward study enrollment goals. Additionally, the Monthly Report informs the metrics that run in an adapted validated protocol complexity assessment, Ontario Protocol Assessment Level (OPAL) tool, called the Clinical Research Workload Tool (CRWT). In effort to assess each team member’s workload given the complexity of their studies and the number of patients they have enrolled and remain active or are seen for follow- up to treatment and several other additional workload factors. Evaluating productivity and workload on the Monthly Report allows leadership to make informed decisions about study management and the distribution of staff resources to study coverage plans and the like.
3. SCOPE
The development of informed and sustainable coverage plans is a function of adequate analysis of what the study portfolio necessitates on the part of the team leads, and what the research staff can fulfil given their credentials, workload, and availability (i.e., leave of absence or special accommodations through ADA may preclude a particular team members from assuming certain assignments).
4. RESPONSIBILITIES
4.1 Leadership and the RA team play a collaborative role in ensuring patient safety and the quality of the research are upheld. On the start of any study assignment, an appraisal of the Monthly Report and CRWT reports will help inform which team member would be a good candidate for the primary, back-up and RN roles CRC. Additional considerations include the PI’s preference and the potential team member’s experience
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