Published on 27/12/2025

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.

Table of Contents

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 for Investigational Product (IP) storage and accountability.
Data Entry Staff: Maintains eCRF

entries and responds to data queries.

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.