Good Clinical Practice (GCP) Training

Good Clinical Practice (GCP) training pertains to the international ethical and scientific standard expected in design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.

USC offers GCP training online through www.citiprogram.org

Who must take GCP Training

Good Clinical Practice (GCP) training is required for study Principle Investigators (PI)s and personnel conducting conducting clinical trials. The requirement applies to clinical trials at all levels of IRB review.

PIs and staff on new studies and any new staff on ongoing studies meeting the NIH definition of a clinical trial must complete GCP training.

NIH Definition of “Clinical Trial”
A clinical trial is a “research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”.

GCP training is intended for study staff who collect data through intervention or interaction with a subject or have access to private identifiable information however, any member of a study team may be asked to take GCP training at the request of the IRB.

GCP Course Content

There are two GCP course tracks provided at www.citiprogam.org

GCP for Clinical Trials with Investigational Drugs and Biologics

GCP for Clinical Trials with Investigational Medical Devices

1. Comparison Between ICH GCP E6 and U.S. FDA Regulations
2. Investigator Obligations in FDA-Regulated Research
3. Managing Investigational Agents According to GCP Requirements
4. Informed Consent in Clinical Trials of Drugs and Biologics
5. Monitoring Clinical Trials of Drugs by Industry Sponsors
6. Audits and Inspections of Clinical Trials of Drugs and Biologics
7. New Drug Development
8. International Conference on Harmonization (ICH) GCP
9. ICH—Comparison Between ICH GCP E6 and U.S. FDA Regulations
10. Detecting and Evaluating Adverse Events
11. Reporting Serious Adverse Events in Investigations of Drugs and Biologics
1. Conducting Investigator-Initiated Clinical Investigations of Medical Devices
2. Investigator Obligations in FDA-Regulated Clinical Investigations of Devices
3. Managing Investigational Devices According to GCP Requirements
4. Overview of U.S. FDA Regulations for Investigational Devices
5. Informed Consent in Clinical Investigations of Devices
6. Monitoring Clinical Investigations of Devices
7. Audits and Inspections of Clinical Investigations of Devices
8. Reporting Requirements for Clinical Investigations of Devices