Glossary
Site feasibility assessment
How sponsors and CROs check whether a site can run a specific trial: its patient population, staff, equipment, competing studies and past enrollment.
What does Site feasibility assessment mean in clinical research?
Feasibility assessments establish a site's capability to conduct clinical trials and its suitability for a specific trial.[1] In practice, a sponsor or CRO sends a questionnaire asking how many eligible patients the site sees, what staff and equipment it has, which competing studies it runs, and how it has enrolled in similar studies.
Feasibility answers become the enrollment numbers a site is held to, so they should come from data rather than memory. An ASCO task force called the feasibility methods sponsors and CROs use costly, inefficient and unnecessarily burdensome, and recommended a uniform process, fewer and standardized questions, and technology to reduce redundancy.[1] CTTI recommends moving recruitment planning upstream, alongside trial design.[2]
Practical note: base patient counts on a records query. Under HIPAA, reviews preparatory to research allow that kind of count without authorization if no PHI leaves the covered entity.[3] Start from the feasibility questionnaire template, and see Identify, which screens EHR records against a study's criteria.
Sources
- 1.Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement · JCO Oncology Practice (ASCO), via PubMed, 2021Quote: "Feasibility assessments (FAs) are important to establish site capabilities to conduct clinical trials and their suitability for specific trials. However, current FA methods used by biotechnology and pharmaceutical (biotech-pharma) trial sponsors and contract research organizations (CROs) are costly, inefficient, unnecessarily burdensome, and resource intensive." Recommendations: "(1) implement a streamlined and uniform FA process across trials and sponsors; (2) minimize and standardize questions; and (3) leverage technology to centralize FAs, facilitate communications, and reduce redundancies."
- 2.CTTI Recommendations: Planning for Successful Trial Recruitment · Clinical Trials Transformation Initiative, 2018
- 3.45 CFR 164.512(i)(1)(ii) Reviews preparatory to research · eCFR (HHS Office for Civil Rights), 2026