Quality Assurance

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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.

Training

QA Team Training Schedule
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