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  • Preclinical & Laboratory Foundations Learning Path
  • Phase I – First-in-Human Trials Learning Path
  • Phase II & III – Efficacy & Pivotal Trials Learning Path
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval

About

Clinical Trial Billing Compliance is recommended for clinical research coordinators, research finance and billing analysts, research administration and grants staff,compliance and audit professionals, principal and sub-investigators, research pharmacy/imaging/laboratory operations, CRO clinical monitors, sponsor finance teams, and hospital revenue-cycle staff who touch research claims. No finance background is required. On completion, learners can describe the full money flow through a trial, perform a defensible coverage analysis (US MCA + UK SoECAT), build a protocol-aligned budget, recognise the top-twenty billing errors and apply preventative controls, prepare for internal, sponsor, regulatory and payer audits against the 48-hour readiness standard, run a structured CAPA, apply a full RACI across CRC, PI, finance, pharmacy, compliance, sponsor and CRO, and benchmark and improve organisational maturity. Aligned to US NCD 310.1, False Claims Act and Anti-Kickback Statute, UK HRA SoECAT and NHSCFA, EU CTR 536/2014, and ICH-GCP E6(R3).

Who Should Enrol?

  • Clinical research professionals involved in clinical trial finance, budgeting, and billing activities.
  • Clinical Trial Administrators, coordinators, and operations staff managing study budgets and cost allocation.
  • Sponsors, CRO personnel, compliance, and quality assurance professionals responsible for billing oversight.
  • Healthcare, finance, and life sciences graduates seeking to build careers in clinical trial billing compliance.
📢 Every purchase also includes our FREE companion Clinical Trial Billing Compliance eBook, designed to help you apply principles in real-world clinical trial settings.

What you will learn

Understand the fundamentals of clinical trial billing compliance, including cost structures, billing workflows, and the importance of accurate clinical trial financial management.

Learn regulatory and compliance requirements, including coverage analysis, budgeting principles, and governance frameworks used in global clinical trials.

Develop knowledge of end-to-end billing processes, common billing errors, risk areas, and strategies to ensure accurate and compliant billing practices.

Gain practical skills in audit readiness, inspection preparation, case-based decision-making, and implementing best practices for operational excellence in clinical trial billing.

Course Syllabus

  1. What is billing compliance?
  2. The three-question framework
  3. Three money flows

  1. SOC vs Research
  2. Sponsor / Payer / Institution
  3. Edge cases

  1. United States
  2. United Kingdom
  3. European Union + global

  1. What a CA actually is
  2. The QCT determination (US)
  3. The 22-column CA
  4. SoECAT at a glance (UK)
  5. Linking CA to budget
  6. Mistakes and scenario

  1. The ten stages
  2. Documentation per stage
  3. The charge-capture control

  1. The top-20 errors
  2. Deep dive — the top 5
  3. Signals and response

  1. The four kinds of audit
  2. What auditors expect
  3. Red flags
  4. The 48-hour readiness standard

  1. Role-by-role
  2. Full RACI
  3. Governance
  4. Culture

  1. Case 1 — US AMC multi-trial double-billing
  2. Case 2 — UK NHS trust audit failure
  3. Case 3 — Protocol misinterpretation
  4. Case 4 — German payer dispute
  5. Decision exercises

  1. The maturity model
  2. A 12-month improvement roadmap
  3. Continuous improvement
  4. The enterprise business case
  5. Course complete

  1. 📘 Bonus: Clinical Trial Billing Compliance eBook (Free with purchase)

Our Certified Customers

novartis
NHS
takeda
roche
baxter

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