Good Clinical Practice (GCP) is a quality standard provided by the International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. At Dong-A University Hospital CTC, our Quality Assurance team maintains determined vigilance for the protection of human subjects in clinical trials. Our team reviews all protocols on how clinical trials should be conducted, provides assurance for the safety and efficacy of new compounds and monitors the roles and responsibilities of trial sponsors and clinical investigators. We pride ourselves on outstanding quality assurance and quality control.
QA Team Training Schedule | |
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Items | Frecquency |
Regulations and Compliance For clinicians to become a clinical investigator (Principle investigator) |
Every 2-3 months |
Clinical Trial “Current state and Requirements” | As needed |
GCP Training for all researchers and IRB members at DAUH | Twice/year |
Online Education/Certifications Collaborative institutional Training Initiative (CITI) accreditation |
Twice/year |
Further certification (SoCRA, ACRP, KoNECT etc.) | Every 2 months |