Published on 22/12/2025

Developing SOPs and Templates for Clinical Trial Feasibility Assessments

Standard Operating Procedures (SOPs) and templates form the backbone of a compliant and efficient clinical trial feasibility process. They provide structure, consistency, and transparency during site qualification and selection. This guide walks you through the key elements of creating and using feasibility assessment SOPs and standardized templates that align with ICH-GCP and sponsor expectations.

Table of Contents

Why Feasibility SOPs Are Critical

Feasibility assessments without SOPs can lead to:

Inconsistent evaluation criteria
Subjective site selection decisions
Poor documentation for audits and inspections
Overlooked risks related to staffing, infrastructure, or recruitment

Structured SOPs ensure all stakeholders follow a unified process and that documentation is suitable for regulatory inspection and TMF filing.

Core Components of a Feasibility SOP

1. Purpose and Scope

Defines why the SOP exists (i.e., to evaluate and select suitable trial sites)
Specifies applicable roles (sponsors, CROs, CRAs, feasibility teams)
Outlines the lifecycle from site outreach to final selection

2. Responsibilities

Feasibility Manager or CRA: Distribute questionnaires, schedule interviews
Clinical Operations: Score and document responses
Regulatory Affairs: Verify licensure, ethics committee info
Sponsor Oversight: Final approval of site selection

3. Feasibility Workflow

Site pre-screening and outreach
Distribution of feasibility questionnaire and materials
Receipt, review, and clarification of responses
Virtual or in-person PI interview and facility tour
Scoring of site using predefined metrics
Documentation and final decision

4. Documentation Requirements

Completed

and signed feasibility questionnaire

Investigator CVs and GCP certificates

Site infrastructure photos or virtual tour screenshots

Feasibility scoring sheet or site selection justification memo

Final approval form for selected sites

Essential Feasibility Templates

Standard templates not only speed up the process but also reduce variability. Common templates include:

Site Feasibility Questionnaire (SFQ): Tailored per protocol, covering PI experience, recruitment estimates, infrastructure, and EC timelines
PI Interview Checklist: Covers availability, protocol understanding, and site engagement
Infrastructure Checklist: For IP storage, diagnostics, labs, internet connectivity, and patient access
Feasibility Scoring Matrix: Weighted scoring based on protocol-specific priorities
Site Selection Summary Template: Documents rationale for selecting or rejecting each site

Refer to resources like Pharma SOP templates to access pre-validated forms aligned with GCP.

Integration with CTMS and eTMF Systems

Many SOPs now include digital workflows through:

Clinical Trial Management Systems (CTMS) for site tracking
eTMF storage of feasibility records under Section 02 (Central/Local Site Documents)
Automated reminders for questionnaire deadlines and review cycles

Digital integration enhances traceability and audit readiness.

ICH-GCP and Regulatory Alignment

According to USFDA and CDSCO guidance, site selection must be based on documented qualification and capabilities. ICH-GCP E6(R2) requires sponsors to ensure sites have the resources to conduct the trial in compliance with the protocol and regulations. Your feasibility SOP must reflect this responsibility.

Feasibility SOP Training and Version Control

All CRA and feasibility team members must be trained on SOP implementation
Maintain training logs and test comprehension via post-training quizzes
Use version control systems to track SOP revisions and effective dates

Common Pitfalls to Avoid

Generic SOPs not tailored to therapeutic area or region
Lack of documented site selection rationale
Disorganized records or missing feasibility responses
Scoring inconsistency across feasibility reviewers

Best Practices for SOP Implementation

Conduct feasibility kick-off meetings with all stakeholders
Customize templates per protocol while preserving SOP structure
Use feasibility decision logs for transparency
Review SOP compliance during site audits or monitoring visits

Conclusion

A strong SOP-driven feasibility process improves trial quality, operational efficiency, and regulatory compliance. With standardized templates and well-documented workflows, sponsors and CROs can identify, assess, and select high-performing sites with confidence. Implementing robust feasibility SOPs is not just about documentation—it’s about ensuring your clinical trial starts on a foundation of preparedness and reliability.