Page 564 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Adm-003
SOP Title: Measuring Productivity: Monthly Report
1. PURPOSE
The purpose of the current standard operating procedure (SOP) is to define the team leader’s initiative to evaluate Monthly progress by the clinical research coordinators (CRCs) and associates (CRAs) of Research Administration (RA) toward the goals established for their studies.
2. INTRODUCTION
Commitment to excellence and becoming a department of choice are a shared focus in RA. In a collaborative effort toward this vision, leadership measures the productiveness of the RA toward established study goals in the Monthly Report.
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 resources to departmental demands.
3. SCOPE
The scope of the Monthly Report applies to all of RA. Specifically, each CRC and CRA of the RA is expected to turn in a report to their team lead. The Monthly reports are completed and evaluated by the team leads, reported to the director for their review, and occasionally escalated to senior management. The Monthly Report is used to inform study assignments, the distribution of workload, staffing needs, and partially informs long-term goals for the RA department structure.
4. RESPONSIBILITIES
4.1 All CRCs and CRAs are asked to complete a Monthly report of their study progress. Their Monthly report is due by noon on Friday each month to their team lead. Each CRC and CRA is expected to provide the following in their Monthly report for each study for which they take an active role:
• Study IRB Number
• Total Number of Patients Enrolled on the Study
• Total Number Expected to be Enrolled on the Study
• Total Active Patients on the Study
• Total patients enrolled this month
• Total Number of Patients Screened
• Date of Last Contact with the PI
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