Investigational drug services operations: Defining core and supplemental workload metrics
Diana Nicole Nowicki, Kangwon Song, S Karl Gotzkowsky, Michelle Yu, Amanda J EwaldAbstract
Purpose
Investigational drug services (IDS) support highly complex and regulated aspects of clinical research, yet the absence of defined workload metrics limits clear and consistent understanding of IDS workload across pharmacy, research, and executive leadership. Staffing and resource requests, as well as being responsible for acceptance of new studies, require defensible, numerical workload data to secure leadership approval for additional resources. We developed a structured approach to IDS workload measurement that includes broadly applicable core metrics and site-specific supplemental metrics to support staffing justification, resource allocation, and operational planning.
Summary
A modified Delphi process informed by literature-identified metrics was used to achieve expert consensus on IDS workload definitions and metrics. Subject matter experts in IDS pharmacy practice and clinical research operations participated in iterative rounds of review. Metrics were categorized into core workload elements and supplemental metrics. Core metrics broadly describe site characteristics and day-to-day operations. Supplemental metrics capture study-specific, expanded services or site-derived time-based measures.
Conclusion
Organizing IDS workload into core and supplemental components provides a structured method to account for both routine operations and expanded study- or site- driven demands using consistent and meaningful terminology, creating a foundation for capturing and describing IDS workload data.