The NIH and its Institutes recognize that translation of novel drugs and devices requires a well-trained research workforce. Currently, there is a significant gap in competency-based training for investigators and their research teams who are involved in conduct of FDA regulated clinical research. 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. The FDA recognizes this gap in training as well and requires GCP training for researchers who engage in FDA regulated research. MCW leadership recommends the following approach as the easiest way to achieve this expectation. This policy only applies to researchers engaged in FDA regulated research, as defined below.
GCP training implementation plan and timeline
GCP training implementation plan and timeline
MCW has already purchased the GCP module through CITI – Collaborative Institutional Training Initiative (https://www.citiprogram.org/index.cfm?pageID=90). Access to the CITI GCP module will be available to all MCW faculty and staff, CTSI members, and CTSI adjunct faculty. Faculty and staff members from local partner institutions will also have free access to this training via this mechanism. Depending on individual knowledge, it is expected that GCP training can be completed in 3-6 hours.
FDA regulated studies are those that involve drugs, devices, in-vitro diagnostic devices or biologics in human subjects. If you have questions about whether your study falls under FDA regulations, please contact the IRB office at 955-8422. Research personnel who are involved in FDA regulated studies that fit the following criteria will require GCP training, with exemptions noted below:
FDA regulated studies defined as:
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.
Critical Dates
Critical Dates
Critical dates for the completion of GCP training for individuals who meet the above criteria:
October 1, 2016
Research personnel who are identified within eBridge as:
Principal Investigators
Co-PIs
Lead study coordinators
The following individuals must complete GCP training if their research is FDA regulated:
CTSI sponsored KL2, TL1 and Clinical Scholars
MCW Clinical Trial Office (CTO) research coordinators
Adult, Children’s and VA Translational Research Unit (TRU) staff
December 31, 2016
All other research personnel on the above defined studies must also complete GCP training.
Tracking of GCP training
Tracking of GCP training
Changes will be made to eBridge by April 30, 2016 to track GCP training. Subsequently reports will be provided to MCW Leadership to monitor those who have complete GCP training.
Acceptable GCP training, reciprocity arrangement, and refreshers
Acceptable GCP training, reciprocity arrangement, and refreshers
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. IRB staff will manually enter the alternative GCP training in e-Bridge.
The NIH requires a 3-year refresher of GCP training. 30 day reminders prior to expiration and upon expiration of GCP training will be sent out via eBridge.
In summary, GCP research training is important and easy to do to comply with NIH and FDA rules and to ensure safe, high quality research at MCW and CTSI partners.
Frequently Asked Questions
Frequently asked questions
I have already taken CITI training, do I need to take GCP as well?
If the type of studies you are involved with fit the criteria described above, you will need to take GCP too.
How often do I need to complete this training?
Just like CITI training, GCP is renewable every 3 years.
I have taken Group 1 CITI training, do I need to retake “Biomedical Research and Good Clinical Practices”?
Yes, we have renamed the course categories as follows:
• Biomedical Research (formerly Learner Groups 1 and 2)
• Biomedical + GCP Learner Group 11
• Social/Behavior Research (formerly Learner Groups 4 and 5)
• Community Engagement or Community Based Participatory Research (CBPR), Community Partners – Learner Group 6
I have completed GCP training for an industry trial, do I need to take this again?
If the Training you have taken meets criteria as explained above, you will not be required to re-take GCP. You must, however, re-take it every 3 years
I have completed GCP training at another institution, do I need to take this again?
If the training at the other institution meets criteria as described above, you need not take it. You must, however, re-take it every 3 years. Additionally, you may contact Amit Gode at agode@mcw.edu for further clarification.
I am not involved in FDA regulated clinical research, do I still need GCP training?
No, if you are not involved in FDA regulated research, you need not take this training.
Where do I go to take GCP training?
GCP training is available via the CITI portal. Once you log in, just select the GCP course which will be added to your portfolio to complete. You may complete it at your own pace.
How will I know and track if my staff has taken GCP training?
You can request access to the CITI training Departmental report through the eBridge Help Desk.
I am non-MCW faculty involved in FDA-regulated research, do I need to take GCP training? How will I get access to this training?
All non-MCW faculty are given adjunct faculty status through the CTSI mechanism. Once this is established, you will have access to CITI just like other faculty at MCW.
I still have questions, who do I contact?
In case of questions, please contact Amit Gode at agode@mcw.edu or at 414 805 6999.
NIH Funding Acknowledgment:Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.
