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  • 4. INVESTIGATOR: ICH E6 (R2) Good clinical practice
    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
  • GCP Refresher - Sponsor Responsibilities and GCP Flashcards
    Study with Quizlet and memorize flashcards containing terms like Which of the following is true when a sponsor's responsibilities are transferred to a Contract Research Organization (CRO)?, The sponsor of a study has several responsibilities, including:, According to a definition used in ICH E6, an individual (not a corporation or agency) who
  • ICH E6 R2: Guideline for Clinical Practice - myscrs. org
    These expectations of the PI are now explicitly stated and oversight of all individuals delegated study tasks – including contracted staff working for an investigator on a clinical trial should be included in the Investigator’s oversight plan and actions should be taken to ensure compliance
  • A Guide for Best Practices with Sponsor Oversight - Trial Interactive
    ive and systematic approach to sponsor oversight By integrating these best practices into your clinical trial management, you can navigate the complexities of the trial lifecycle with confdence and increas





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