Site Level GCP – Schedule Y Training
This training provides a brief review of new drug development, clinical trial process, Good Clinical Practice (GCP), 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 training will highlight the 13 principles of ICH GCP as the foundation for all clinical studies. We demonstrate to the investigator and the site staff the basic requirements and procedures throughout the clinical development of an investigational drug.
Objectives
- To educate the Investigators in ICH GCP and other applicable guidelines
- 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)
- Guiding the investigators to perform clinical trials according to the respective guidelines and ethics.
- Who can attend?
- New Principal Investigators
- Seasoned Principal Investigators interested in reviewing responsibilities
- Sub-Investigators
- Physicians interested in participating in clinical research
- Site Researchers
- Study coordinators
- Ethics Committee Members