Center for Clinical Studies

Research Roles and Responsibilities

Revised 03.15.07
Created 2006

Unit Role
Principles, Standards, and Guidance
Education and Awareness
Administration and Management
Monitoring
Noncompliance
Coordination Among Entities
Records and Reporting

Unit Role

The Center for Clinical Studies (CCS) negotiates all clinical study contracts for Washington University Medical School and its affiliated hospitals. In addition, CCS offers clinical investigators a wide range of purchasable services to support both the clinical and administrative aspects of conducting clinical studies. These services include clinical study coordinator services, regulatory and IRB submissions, budget estimates, information services support, and patient recruitment.

CCS reports to the Associate Vice Chancellor for Administration and Finance.

Principles, Standards, and Guidance

Promotes a culture of compliance and adheres to Federal regulations and University and sponsoring agency policies and procedures.
Oversees the development and implementation of institutional policies and procedures for industry-funded clinical trials.

Education and Awareness

Disseminates information and provides guidance regarding compliance with Federal regulations and University and sponsoring agency policies and procedures.
Coordinates with the Human Research Protection Office (HRPO) and the Human Studies Research Quality Assurance / Quality Improvement Program (HSR QA/QI) to develop and implement educational programs and tools to effectively train researchers and staff participating in clinical studies research and related activities.
Requires that key CCS personnel involved in clinical studies research and related activities complete all required education in accordance with Federal regulations and University and sponsoring agency policies and procedures.

Administration and Management

Represents the University to Federal and State regulatory agencies.
Negotiates all clinical study contracts for Washington University Medical School and its affiliated hospitals.
Creates budget estimates and negotiates budget with the sponsor for the CCS-supported clinical study.
Establishes patient care rates and negotiates costs for the CCS-supported clinical study.
Coordinates with the sponsoring agency to administer agency liabilities for the CCS-supported clinical study.
Develops and implements technical systems to manage financial and clinical data for the CCS-supported clinical study.
Acts as liaison between the Principal Investigator and the sponsor for the CCS-supported clinical study.
Provides secure and suitable areas for storage of study records and supplies for the CCS-supported clinical study.
Offers experienced and qualified clinical research coordinators to assist the Principal Investigator.

Monitoring

Works closely with HSR QA/QI throughout the monitoring of the CCS-supported clinical study to help facilitate cooperation and assure compliance with Federal regulations and University and sponsoring agency policies and procedures.
Supports and cooperates with sponsor monitoring efforts.

Noncompliance

Supports and endorses cooperation with University compliance efforts and reports instances of noncompliance to the appropriate compliance office.
Identifies and mitigates damages for compliance violations and adheres to corrective measures.

Coordination Among Entities

Coordinates with HRPO, HSR QA/QI, and the Principal Investigator to help ensure that the CCS-supported clinical study complies with Federal and State regulations and University and sponsoring agency policies and procedures instituted to protect the rights and welfare of human research participants.
Coordinates with Disclosure Review Committee (DRC) to help ensure that potential financial conflicts of interest are disclosed in accordance with Federal regulations and University and sponsoring agency policies and procedures.

Records and Reporting

Creates and maintains records for all clinical study contracts of the University and affiliated hospitals.
Creates and maintains records for the CCS-supported clinical study in accordance with Federal regulations and University and sponsoring agency policies and procedures.
Coordinates with the sponsoring agency and the Principal Investigator to help ensure that that the CCS-supported clinical study remains in compliance with all sponsor reporting requirements.