What information needs to be prepared for investigator-initiated studies of post-marketing drugs for expanded indications

The study of expanded indications for post-marketing drugs is a kind of supplemental registration of drugs, which should be prepared in accordance with the content of drug registration management regulations and strictly in accordance with the GCP process. Investigator-initiated, non-approved indications range of drug clinical research, there is no domestic regulations, generally speaking, the research office can be in accordance with the hospital research project to receive, but the hospital GCP center is not necessarily to receive, because the GCP center to accept the verification of the State Drug Administration, the Drug Administration does not have the provisions of the GCP director of the hospitals depends on the meaning of the hospital. View original post>>