Study Monitoring. The study monitor, as a representative of the Sponsor, is obligated to follow the study conduct closely. In doing so, the monitor will visit the principal investigator and study facilities periodically, and will maintain necessary telephone and letter contact. The monitor will maintain current knowledge of the study activity of the investigator and his/her staff through observation, review of study records and source documentation, and discussion of the conduct of the study with the investigators and staff. The Sponsor or designee will monitor all aspects of the study for compliance with applicable government regulation with respect to the International Conference on Harmonisation (ICH) guideline E6(R1): Good Clinical Practice: Consolidated Guideline and current standard operating procedures. Each investigator is expected to make a reasonable effort to accommodate the monitor when monitoring visits are necessary and to be available during the site visit. Furthermore, the monitor should be provided direct access to source data and documents for trial-related monitoring and internet during the visit.
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