Good Clinical Practice (GCP) Training

VCU requires Good Clinical Practice (GCP) training (Compliance Notice 14-002 Good Clinical Practice Training Requirement) for:

  • all clinical trial* study personnel listed on a VCU IRB-approved clinical trial and
  • all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials.

*‘Clinical trials’ are defined in accordance with the NIH definition: “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.”

VCU offers the following Good Clinical Practice courses to satisfy the requirement for training (which must be repeated within three years):

Course Information and Access

GCP for Social/Behavioral Clinical Trials via NIH

Successful completion of this course is recorded by the Blackboard Grade Center and uploaded into OnCore. Please note that a completion certificate is not provided for this course.

Course Title: GCP for Social/Behavioral Clinical Trials via NIH
Course Platform and Access Instructions: VCU Blackboard
  1. Login to VCU’s Blackboard Portal with your VCUeID.
  2. Click on the “Courses” tab on the top menu.
  3. Search for “NIH” using the Course Search Tab.
  4. To enroll in the course, select “TRAIN-101-101-2017Continuous”, then click “Enroll”.
Renewal Required: Every 3 years
Target Audience: This course has been designed for persons involved in the design, conduct or reporting of social/behavioral research, including physicians, psychologists, nurses, students, staff, and administrators
Required Module Topics:
  • Introduction
  • Research Protocol
  • Recruitment and Retention
  • Informed Consent Communication
  • Privacy and Confidentiality
  • Participant Safety and Adverse Events
  • Quality Control and Assurance
  • Research Misconduct
  • Conclusion

GCP for Biomedical Clinical Trials via CITI:

Successful completion of this course is achieved with completion of all required modules and an average score of at least 80% on all quizzes associated with this course’s module requirements.

Course Title: GCP for Biomedical Clinical Trials via CITI
Course Platform and Access Instructions:

Collaborative Institutional Training Initiative (CITI)

CITI Account-Holders:

  1. Login with your CITI Username (VCU eID) at www.citiprogram.org, then scroll down to “Add A Course”
  2. Select the Good Clinical Practice (GCP) Course to enroll.

New to CITI (no prior CITI login):

  1. Please review information for New Subscribers
  2. Use your VCU e-ID as your username when you set up a new account.

Additional Information:

Renewal Required: Every 3 years
Target Audience: This course has been designed for persons involved in the design, conduct or reporting of biomedical research, including physicians, psychologists, nurses, students, staff, and administrators
Required Module Topics:
  • The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices
  • Overview of New Drug Development
  • Overview of ICH Good Clinical Practice
  • 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 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
  • Audits and Inspections of Clinical Trials
  • Monitoring of Clinical Trials by Industry Sponsors
  • Completing the CITI GCP Course