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Office of the Vice President for Research and Innovation

Good Clinical Practice training

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

  • All clinical trial* study personnel listed on a VCU IRB-approved clinical trial
  • 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 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 Social/Behavioral Clinical Trials via CITI
Course platform and access instructions:

Collaborative Institutional Training Initiative (CITI)

CITI account holders:

  1. Log in with your CITI username (VCU eID) at citiprogram.org, then scroll down to “Add a Course.”
  2. Select the Good Clinical Practice course to enroll.

New to CITI (no prior CITI login):

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

Additional information:

Renewal required:Every three years
Target audience:This course was 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 event reporting
  • 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. Log in with your CITI username (VCU eID) at 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 eID as your username when you set up a new account.

Additional information:

Renewal required:Every three 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 cccording 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
Course Tttle:Clinical Research Coordinator (CRC) – Basic Course
Course platform:CITI
Renewal required:Not at this time
Target audience:The CRC course is intended for CRCs, investigators and other clinical research professionals. It is also useful to those pursuing a career in clinical research. The basic CRC course is intended as foundational, role-based training for learners needing basic CRC training or organizations needing onboarding training for new CRCs.
Required CRC module topics:
  • Clinical research coordinator overview
  • Planning research
  • Funding, financial management and budgeting
  • Working with the Institutional Review Board
  • Protocol review and approvals
  • Principal investigator responsibilities
  • CRC responsibilities
  • Sponsor responsibilities
  • Informed consent
  • Site management, quality assurance and public information
  • CRC resources
  • VCU institution-specific module

Contact us

Lisa Richman Ballance, M.A., CPW, CCP
Executive director for clinical research and compliance
(804) 241-6223
lballanc@vcu.edu 

F. Gerard Moeller, M.D.
Associate vice president for clinical research
(804) 827-1531
fgmoeller@vcu.edu 

Emily Komornik
Clinical research communications specialist
(804) 827-2262
komornikea@vcu.edu 

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