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Clinical Trials Administrative Office Heersink School of Medicine

Clinical Trials Administrative Office

Policies/Procedures

CTAO Internal Password-Protected Documents (Access via Blazer ID/Password/Duo Security)

Internal Activity Cost Schedule Recommendations for Industry-Sponsored Clinical Trials
(version 02/23/2023)



 Clinical Trials Informational Documents  

Clinical Trial Definition

Operating Accounts

Effort Reporting Policy

Study Management Fee

Study Close-out Workflow

Clinical Trials F&A Cost Guidance

Best Practices: Clinical Trial Operating Account

Emergent Use Request Process for Investigational Drugs

Clinical Research Billing Responsibilities and Process (Appendix A)

Device Trial Investigator Agreement Procedures



Clinical Trials Industry-Sponsored Documents  

At-Risk Accounts for Industry-Sponsored Clinical Trial Agreements

Guidelines for Pending Accounts in Industry-Sponsored Clinical Trials

External Standard Fee Schedule for Industry-Sponsored Clinical Trials 



Clinical Trials Position Statements 

Position Statement: Screening and Withdrawal Visits

Position Statement: Responsibility for Copays/Deductibles for Routine Care in a Clinical Trial

Position Statement: Responsibility for Payment of Conventional or Routine Care in Clinical Trials

Position Statement: Responsibility for Payment of Costs Associated with Subject Medical Injury in Industry-Sponsored Clinical Trials



Charters

CTAC Charter

DCCAG Charter
(version 07/20/2022)



Clinical Protocol Activation Process (CPAP)

CPAP Information and Flowchart