A Clinical investigator is defined as "an individual who actually conducts a clinical
investigation." When a investigator signs an Investigator's agreement for durns, 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
involvement in the study,
6) To retain all records required by GCP guideline for 5 years.
7) To allow sponsors' and government representative to inspect the records of the
study (monitoring).
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