Assignment Task: In general, the clinical research associate oversees the site to ensure that the study is conducted in compliance with regulations and GCP guidelines, and that: Need Assignment Help?
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A) All adverse events and unanticipated problems involving risks to subjects or others are appropriately reported.
B) The study is conducted according to the protocol and applicable amendments
C) The site study file is complete and up-to-date, including all reports, notifications, applications, and submissions
D) The clinical research coordinator trains the investigator and all the assistants at the site
E) Enrolled subjects meet eligibility criteria
F) Informed consent is obtained before subjects begin study participation and a plan is in place for continued informed consent throughout the study
G) Investigational product is properly stored and dispensed
H) Resources at the investigative site are adequate to conduct the tria
I) Required data are collected and recorded accurately, as compared with source documents