Published on 22/12/2025
How to Assess PI and Staff Availability During Clinical Trial Feasibility
One of the most critical yet often overlooked components of site feasibility is evaluating the availability of the Principal Investigator (PI) and supporting staff. A well-equipped site can still underperform if key personnel are stretched thin or unavailable during critical study phases. Ensuring dedicated and timely involvement from the PI and site team during feasibility reduces risks, improves data quality, and keeps your trial on schedule. This article explains how to assess staff and PI availability during the feasibility stage.
Why PI and Staff Availability Matters
Site success is driven not just by infrastructure or patient availability but also by the people running the study. Inadequate staff time allocation can lead to:
- Delayed protocol compliance and patient enrollment
- Missed assessments or visits
- Data entry backlogs and query delays
- Poor communication with CRAs and sponsors
Therefore, understanding the day-to-day bandwidth of the PI and the study team is vital for feasibility decision-making.
Key Roles to Evaluate During Feasibility
- Principal Investigator (PI): Must provide oversight, conduct informed consent, and ensure protocol adherence.
- Sub-Investigators: Support the PI in clinical assessments and subject monitoring.
- Study Coordinator: Handles scheduling, visit logistics, and EDC entry.
- Pharmacist: Responsible
Questions to Include in Feasibility Forms
Include targeted queries in your feasibility questionnaire to gauge real-world availability:
- “How many trials is the PI currently overseeing?”
- “Will the PI be present during all SIV and first patient visits?”
- “What are the backup arrangements for the PI?”
- “List ongoing trials with estimated time commitments.”
- “Do you foresee any planned leave or sabbaticals during the study period?”
These responses help determine whether a site is overburdened or capable of taking on a new trial.
Conducting PI Interviews
Beyond forms, personal interviews (virtual or in-person) with the PI offer critical insights. During these, assess:
- Understanding of the protocol and enthusiasm for the study
- History of protocol compliance and inspection outcomes
- Whether the PI has blocked time in their calendar for subject visits and AE reviews
- Communication approach with site staff and CRAs
Record responses in a centralized Pharma SOP checklist for internal documentation.
Evaluating Support Staff Availability
Aside from the PI, staff availability is critical for seamless operations. Look into:
- Ratio of full-time coordinators per trial
- Availability of trained backup coordinators or data entry personnel
- Dedicated pharmacy and lab personnel for sample handling and IP dispensing
- Training records and certifications as per GMP guidelines
Red Flags to Watch For
- PI involved in more than 5 concurrent trials without sub-I support
- Unplanned or frequent PI absences in historical trials
- High turnover rate in study staff
- Shared staff across departments without trial prioritization
- Lack of clarity about who will perform study procedures
Documenting Availability in CTMS
Capture availability metrics in your Clinical Trial Management System (CTMS) such as:
- PI % allocation to this study
- Average daily availability of study coordinators
- Scheduled training sessions for protocol-specific tasks
- Planned absences or institutional leaves
Using a PI and Staff Readiness Scorecard
Create a weighted scorecard during feasibility assessment with parameters such as:
- PI commitment (30%)
- Staff-to-study ratio (25%)
- Historical compliance (20%)
- Contingency planning (15%)
- Protocol understanding (10%)
This scorecard ensures objective comparison between candidate sites.
Regulatory Expectations
As per USFDA and ICH GCP (E6 R2) guidance, the PI must maintain overall responsibility for trial conduct. Sites must demonstrate adequate human resources at the time of feasibility. Audit findings often cite PI absenteeism or lack of oversight as major issues in trial quality.
Conclusion
Assessing PI and staff availability is a fundamental pillar of feasibility assessment. Sponsors must ensure that key personnel are not only qualified but also sufficiently available to maintain protocol compliance and patient safety. A structured approach—through interviews, checklists, and scorecards—helps quantify availability and minimize trial delays.