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  • Preclinical & Laboratory Foundations
  • Phase I – First-in-Human Trials
  • Phase II & III – Efficacy & Pivotal Trials
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval
Preclinical & Laboratory Foundations - courses at £229
  • Good Laboratory Practice (GLP)
  • 21 CFR Part 58 — Good Laboratory Practice (GLP) for Nonclinical Laboratories
  • OSHA Laboratory Safety Training
  • Laboratory Management Systems ISO/IEC 17025:2017
  • Computer System Validation - Validation, Data Integrity & Compliance (GAMP 5 & Annex 11)
  • Qualification Validation Training
  • Cleaning Validation
  • ISO 9001:2015 - Quality Management System for Pharmaceuticals

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).

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

Our Certified Customers

novartis
NHS
takeda
roche
baxter

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I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...