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.
- Identify the key stages of the drug development process
- Describe the elements involved in the clinical trial process
- Apply the principles of ICH GCP to current clinical trials
- Examine the Investigator’s responsibilities in the conduct of clinical trials as required in the regulations (CFR) and guidelines (ICH)
- Recognize the commitment made in executing the Form FDA 1572
- Principal Investigators (new)
- Seasoned Principal Investigators interested in reviewing responsibilities
- Physicians interested in participating in clinical research
- Site Research Managers/Directors
Gary B. Freeman, M.S., C.C.R.A., C.C.R.T.
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3 hours; 12:30 – 3:30 p.m. Eastern
March 21, 2011
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471