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CITI Program

Collaborative Institutional Training Initiative at the University of Miami

GOOD CLINICAL PRACTICE (GCP)

The GCP series includes three distinct basic courses tailored to the different types of clinical research, along with three corresponding refresher courses that are intended to provide learners with a highlighted review of what is covered in the basic modules.

The available GCP courses include:

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)*
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)*
  • GCP for Clinical Investigations of Devices
  • GCP FDA Refresher*
  • GCP ICH Refresher*
  • GCP Device Refresher
* TransCelerate Mutually Recognized GCP Training

For the GCP Courses marked above, ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Available translations that meet TransCelerate minimum criteria include:

Spanish

  • Curso de Buenas Prácticas Clínicas (Enfocado en la FDA, Estados Unidos)
  • Curso de Buenas Prácticas Clínicas para Ensayos Clínicos con Drogas (Enfocado en ICH)

Portuguese

  • Curso de Boas Práticas Clínicas (Enfoque na Administração Federal Americana de Alimentos e Medicamentos)
  • Curso de Boas Práticas Clínicas para Testes Clínicos Envolvendo Medicamentos (Enfoque ICH)

For a listing, description, language availability, and recommended use of each module in the GCP series, download the GCP Catalog (PDF file).

For recommendations on using this series, download Using CITI Program Content: Good Clinical Practice (PDF file).

Audience

GCP content is suitable for research teams involved in clinical trials of drugs, biologics, and devices.

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) and GCP FDA Refresher are suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.

GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) and GCP ICH Refresher are suitable for individuals involved in clinical trials of drugs and biologics when the research may be international or where the individuals would prefer a more ICH-focused curriculum.

GCP for Clinical Investigations of Devices and GCP Device Refresher are most appropriate for organizations or individuals who desire a more international-focused GCP curriculum and a more device-focused program. These device courses cover FDA regulation as well as International Organization for Standardization Guidelines ISO 14155:2011.

Pricing and Subscription Options

Available to subscribing organizations as a part of the base subscription. Independent Learner registration is available for $110 USD.

CMEs/CEUs

View the list of courses approved for CE credits and units.