Clinical Trial Site Feasibility and Allocation Matrix

Role: Principal Director of Global Clinical Operations with 18 years leading multi-center pharmaceutical trials.

Context

• Protocol reference: {{trial_protocol_id}}
• Indication domain: {{therapeutic_area}}
• Evaluated site profiles: {{site_candidate_profiles}}
• Cohort enrollment quota: {{target_patient_enrollment}}
• Compliance zones: {{regulatory_jurisdictions}}
• Biologics handling specs: {{cold_chain_requirements}}

Task

Construct a comprehensive multi-criteria site feasibility scoring matrix that evaluates candidate clinical trial sites, isolates operational bottlenecks, and prescribes tier-ranked site activations to guarantee protocol timelines and compliance.

Method

1. Parse {{site_candidate_profiles}} against {{target_patient_enrollment}} to compute historical recruitment velocity and screen-failure projections.
2. Cross-reference local ethics committee turnaround benchmarks across {{regulatory_jurisdictions}} to establish site activation lead times.
3. Audit equipment capabilities against {{cold_chain_requirements}} for investigational product storage integrity.
4. Establish weighted scoring dimensions: Enrollment Capacity (30%), Regulatory Speed (25%), Infrastructure & Cold-Chain (25%), and Investigator Experience (20%).
5. Calculate raw and normalized feasibility indices for each candidate clinical institution.
6. Map identified operational vulnerabilities to mitigation strategies, highlighting backup recruitment pathways.
7. Categorize candidate sites into Tier 1 (Immediate Activation), Tier 2 (Conditional Contingency), and Tier 3 (Disqualified).
8. Synthesize final portfolio resource allocation recommendations into an executive decision summary.

Constraints

• MUST score every site across all four defined weighting dimensions using a 1-5 integer scale.
• MUST NOT recommend Tier 1 activation for any site failing {{cold_chain_requirements}} validation.
• Total weighted feasibility score MUST be mathematically explicit in the matrix.
• Rationale for site disqualification or contingency placement must be supported by empirical evidence from {{site_candidate_profiles}}.

Output format

Generate the output in two structured sections:

1. "Feasibility Evaluation Matrix": A markdown table with columns: Site ID, Enrollment Score (1-5), Regulatory Velocity Score (1-5), Cold-Chain Compliance (Pass/Fail), Composite Weighted Score (100-pt scale), and Activation Tier.
2. "Operational Governance Matrix": A secondary markdown table linking each site to its primary bottleneck, mandatory pre-activation remediation, and designated operational lead.

Self-review

• Confirm all variables from {{trial_protocol_id}} through {{cold_chain_requirements}} are integrated.
• Verify mathematical consistency between sub-scores and composite weighted scores.
• Ensure zero unverified assumptions regarding cold-chain infrastructure viability.