MCW Good Clinical Practice Training

About Good Clinical Practices Training

The NIH and its Institutes recognize that translation of novel drugs and devices requires a well-trained research workforce. The National Center for Advancing Translational Science (NCATS) as part of its mission to improve the quality of clinical and translational research nationally has initiated a series of innovative programs that make Clinical and Translational Science Award hubs and partner organizations great places to conduct high quality research. The leadership at the Medical College of Wisconsin and the Clinical and Translational Science Institute of Southeast Wisconsin (CTSI), embrace these high standards and training for our researchers. We believe that the addition of Good Clinical Practice (GCP) training will equip study personnel with the necessary and fundamental competencies to conduct FDA regulated clinical research.

CTSI GCP Training Requirements

MCW offers Good Clinical Practices (GCP) courses through Collaborative Institutional Training Initiative (CITI); Good Clinical Practice course (US FDA focus) and GCP-Social and Behavioral Research Best Practices for Clinical Research.

• MCW requires MCW faculty and staff engaged in FDA regulated research that fit the following criteria to complete GCP training: 
• Studies that involve the use of any drug or biologic therapy (including botanicals, dietary supplements, medical foods, etc.) for purposes other than routine clinical care (including physiological challenge tests).
• Safety or efficacy evaluations of any apparatus that the FDA does or might consider to be a “medical device.
• Safety or efficacy evaluation of any type of diagnostic test (including “in vitro” diagnostic tests, or “companion” / “complementary” (usually genetic) diagnostic tests).
• Any study where the results will be submitted at a later date to the FDA in support of some drug, biologic, medical device, or in vitro diagnostic test application.
• CTSI‐funded studies including Translational Research Unit and Imaging Center studies that are FDA regulated.
• Protocols submitted to IRB that used CTSI Biostatistics Research Design consultation that are FDA regulated.

Completion of GCP training may require three - six hours.

The NIH requires a 3‐year refresher of GCP training.

In case of questions regarding GCP training, please contact Amit Gode, (414) 805-6999.

GCP training by the Association of Clinical Research Professionals (ACRP) or from other accredited sources including industry based programs during the past three years is an acceptable alternative to CITI GCP training. Please provide documentation of the organization providing training, topics covered, hours to complete it, and contact person at the organization to Amit Gode.

CTSI and MCW GCP Research Training Requirement - FAQ (PDF)