Who holds ultimate responsibility for overall management and financing of a clinical trial?

Answer

Sponsor

The Sponsor occupies the highest level of accountability within a clinical trial structure. This entity, which can be an individual or an organization, is specifically defined by its function of providing the necessary financing for the study. Beyond just funding, the Sponsor assumes ultimate responsibility for the entire trial's overall management. This responsibility includes ensuring that the entire research endeavor strictly complies with all relevant legislation governing clinical research and adheres robustly to the principles of Good Clinical Practice (GCP). Importantly, even if the Sponsor delegates specific management or monitoring tasks to a third party, such as a Contract Research Organization (CRO), the legal and ultimate accountability for the proper execution of those delegated functions remains squarely with the Sponsor.

Related Questions

Who holds ultimate responsibility for overall management and financing of a clinical trial?What primary responsibility does the Principal Investigator (PI) hold at each participating site?How does the Clinical Research Associate (CRA) typically differ from the Clinical Research Coordinator (CRC)?What statistical contributions does the Biostatistician make during the trial design phase?What is the primary function of the Quality Assurance (QA) Team regarding trial standards?Which role is indispensable for daily functioning, scheduling, and adherence to GCPs at the site?If a trial is multinational, who appoints the Principal Investigator (PI) for every participating site?Whose role centers on ensuring research drugs are administered safely and optimally?What is the primary responsibility of the Regulatory Specialist concerning study documentation?What contribution do Public and Patient Involvement (PPI) representatives offer the trial team?

Role research Trial participant investigator