This web seminar provides a brief review of new drug development and the clinical trial 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
- New Principal Investigators
- 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.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 3 hours (0.3 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-14-021-L01-P. Released: 5/14.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471