Pharmaceuticals & Biotech

Clinical Investigator Site Payment

Recording payments to clinical investigation sites and principal investigators for patient visits in a clinical trial.

Account NameTypeDebit ($)Credit ($)
Clinical Site Fees (R&D Expense)Expense (+)1,200,000.00-
Accrued Clinical Site FeesLiability (+)-1,200,000.00

💡 Accountant's Note

Clinical sites (hospitals, research institutions) are paid per-patient-visit fees as defined in the Clinical Trial Agreement. Site fees cover investigator time, patient assessments, laboratory processing, and study coordination. Accruals are based on visit completion data from the EDC (Electronic Data Capture) system.

Practitioner & Systems Framework

💻 ERP Architecture

Site fee accruals are driven by patient visit data from the EDC system (Medidata Rave, Oracle Clinical, or Veeva Vault). The trial management system records each completed patient visit and matches it to the fee schedule in the signed CTA (Clinical Trial Agreement). The finance team runs a monthly extract from the trial management system to calculate the accrual by site and study. Site fee payments are processed through the AP module against the CTA. Fair market value (FMV) rates for investigator payments are a regulatory compliance requirement — payments must not exceed published FMV benchmarks.

⚠️ Audit Flags

Auditors test site fee accruals against the EDC patient visit data. Confirm that the fee schedule in the ERP matches the signed CTA. Review the FMV compliance assessment for investigator payments — above-FMV payments to investigators are a Sunshine Act / anti-kickback risk. Test that patient visit data is complete and not subject to data lock delays that could understate the accrual. For active sites in high-enrolment periods, assess whether the month-end accrual captures all visits completed but not yet entered in the EDC.

📄 Required Documentation

Clinical Trial Agreement (site fee schedule), EDC patient visit completion data, site fee accrual calculation, investigator payment FMV assessment, site payment register by investigator, Sunshine Act (Open Payments) reporting data, AP payment records to sites, and CTA amendment tracking.

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