This course provides a brief review of new drug development and the clinical trials process as it affects the Investigator, and explains where Good Clinical Practice (GCP) fits in. Relevant sections of the Code of Federal Regulations (CFR), International Conference on Harmonization (ICH), and Form FDA 1572 are discussed in-depth and in relationship to the Investigator's responsibilities for proper conduct of clinical trials. This course will highlight the 13 principles of ICH GCP as the foundation for all clinical studies, and demonstrate to the Investigator the rationale for sponsor requirements throughout clinical development of an investigational drug.
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