Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 114

The sponsor and investigator are two key players in the clinical trial process. The sponsor is “an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial” (ICH E6(R2) 1.53). The investigator is “a person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator” (ICH E6(R2) 1.34). The sponsor and investigator must comply with the GCP guidelines and regulatory requirements that clearly describe their respective trial‐related duties and responsibilities. The sponsor may transfer any or all of their study‐related duties to a CRO and the regulatory obligations that are associated with the transferred task; however, the sponsor retains regulatory responsibility for the oversight of the CRO and the overall safety of trial subjects and integrity of the trial data. The investigator may also delegate trial‐related duties to staff or subcontractors; however, the investigator retains all regulatory obligations associated with delegated or subcontracted tasks.