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CCRP
> ICH-Comparison Between ICH GCP E6 and U.S. FDA Regulations > Flashcards
ICH-Comparison Between ICH GCP E6 and U.S. FDA Regulations Flashcards
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CCRP
(13 decks)
The CITI Good Clinical Practice Course for Clinical Trials with Investigational Drugs and Medical Devices
Overview of New Drug Development
Overview of ICH GCP
ICH-Comparison Between ICH GCP E6 and U.S. FDA Regulations
Conducting Investigator-Initiated Studies According to FDA Regulations and GCP
Investigator Obligations in FDA-Regulated Clinical Research
Managing Investigational Agents According to GCP Requirements
Overview of U.S. FDA Regulations for Medical Devices
Informed Consent in Clinical Trials of Drugs, Biologics, and Devices
Detecting and Evaluating Adverse Events
Reporting Serious Adverse Events
Monitoring of Clinical Trials by Industry Sponsors
Audits and Inspections of Clinical Trials
