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CCRP > Informed Consent in Clinical Trials of Drugs, Biologics, and Devices > Flashcards

Informed Consent in Clinical Trials of Drugs, Biologics, and Devices 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

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