Practical Considerations for Investigator

임상연구자의 실제적 고려사항

A Clinical investigator is defined as 'an individual who actually conduct a clinical investigation.' When a investigator signs an Investigator's agreement for durgs, he or she agrees to conduct an investigation according to GCP guidelines and the study protocol. Investigators are responsible for the wellbeing to GCP guidelines and the study protocol. Investigators must obtain IRB approval for the study, the informed consent, and all advertisements to recruit subjects. They must notify the IRB of all changes to the study, and must provide interim reports, and final dose-ut report to the IRB. Regulatory obligations for investigators are ; 1) To maintain adequate and accurate case histories designed to record all observation and data 2) To report serious and unexpected adverse experiences promptly to the IRB and to the sponsors. 3) To report all the information from the studies to the sponsor. 4) To dispense the study drug to subjects under their supervisions and maintain accountability, 5) To obtain written informed consent from all participating subjects prior to their inolvement in the study, 6) To retain all records required by GCP guideline for 5 years. 7) To allow sponsor's and government representative to inspect the records of the study(monitoring).