ICH GCP Obligations of Investigators Conducting Clinical Trials
This course addresses the obligations of investigators as described by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It focuses on the investigator’s responsibilities to protect the rights and welfare of human subjects and ensure data integrity. By extension, these responsibilities also apply to other investigation site staff involved in the planning, conduct, recording, and reporting of clinical trials.
After this course learners will be able to recognize how to comply with gcp guidelines. identify principal obligations with respect to qualifications and agreements, institutional review board/independent ethics committee (irb/iec) communications, and documentation requirements.