Clinical Research Workforce Excellence (CReWE) Program
In accordance with the Feinberg School of Medicine’s Clinical Research Workforce Excellence Program, NUCATS has developed online and face-to-face training materials to further enable the Northwestern research community to carry out compliant research practices.
This program is a required training element for staff and faculty involved in clinical research.
JULY SESSION: Wednesday, July 21, 2021 at 12:00 p.m. CDT via Zoom
TITLE: Research integrity in action: a virtual workshop
PRESENTER: Lauran Qualkenbush, Director, Research Integrity and Research Integrity Officer
- Identify the difference between research misconduct and other research non-compliance
- Understand the University and federal framework for reviewing research misconduct allegations
- Recognize the options for reporting research misconduct concerns
- Review and discuss case studies regarding reporting research misconduct
NOTE: July is the last session for this summer and CReWE sessions will resume this Fall 2021.
The CReWE training program is required for all clinical research staff that are listed on an authorized personnel list of an expedited, exempt, or approved IRB protocol with an FSM faculty as the PI. We will update this list quarterly, and members of the group will be contacted directly about the trainings. The online module and live trainings are available to all university personnel in the myHRLearn system, though the trainings will not be added to the profiles of individuals included in the requirement. You may simply follow the registration instructions here to sign up for a session. If you have any questions, please contact Nicole Masen.
Specific requirements for research staff:
- Clinical research staff should have completed the online module in myHRLearn by Tuesday, April 30, 2019. New staff as of 7/1/2019 will be contacted individually and directly to complete this training.
- The CReWE training workshops will launch in October of 2019 with a training occurring each month throughout the year. Staff on the training list will receive an email notification and are required to attend one of these sessions. Staff should search for the CReWE sessions in the system using these directions and may register themselves for one or more sessions. CReWE program staff may need to prioritize new attendees due to room capacity and will follow up directly if that is the case.
- All sessions will be recorded and available in myHRLearn, though viewing the recording will not count to meet the training requirement.
All faculty who are listed on IRB protocols are required to complete the online faculty training. The FSM Compliance Office will continue to follow up with faculty who are on this training list but have yet to complete the training. At this time, the online module is the only requirement for faculty.
- Feinberg School of Medicine's Human Research Quality Assurance Policy outlines the details for the quality assurance processes
- The Office for Regulatory Affairs supports faculty, staff, students, and trainees in their commitment to follow university policies and standards of conduct to ensure they act ethically and in compliance with all applicable laws
- The Office for Research Integrity partners with the research community in innovative and effective ways to minimize and manage research risks
- Northwestern University's Institutional Review Board (IRB) is primarily responsible for developing and directing the University’s Human Subject Protection Program (HSPP)
- Responsible Conduct of Research (RCR) training is for anyone involved in research aims to help them perform the most ethical research possible
- NUCATS' educational training programs help scientists and research staff gain the skills they need to perform sound clinical and translational investigations
- Feinberg School of Medicine - Quality Assurance Reviews for Clinical Research Studies answers questions about the human subject research quality assurance process
- FDA Audit Resources include templates and examples of FDA Audit correspondence and forms.
- Powerpoint slides from Research Integrity presentation by Lauran Qualkenbush
What is the difference between all these different clinical research trainings? Isn’t this the same as CITI or GCP
These three trainings are all different.
Northwestern University and the Feinberg School of Medicine require GCP training for all investigators, co-investigators and study personnel listed on the Northwestern University IRB application and involved in research defined as follows by the NIH clinical trial definition. Read more about GCP training.
Northwestern University requires Human Subjects Protection/CITI training for all individuals involved in the conduct of human subjects research, with recertification every 3 years. Read more about this training on the IRB website.
FSM requires CReWE training for PIs and staff who are involved in clinical research.
I’m a faculty member and took the online training, but I don’t see the live training sessions in myHRLearn. Are those available?
Not yet. We will contact all relevant faculty when the live sessions are available for sign-up. We will offer approximately twice a year, and faculty are required to attend one training every three years.
Will I get reminders?
Yes, the myHRLearn system will send notifications for the different requirements.
What about clinical residents and fellows? PhD fellows? Medical students? PhD students?
We will follow up with department administrators about any requirements for these groups of trainees. Right now, they are not required to complete the CReWE training.
Someone on my research team didn’t have this training assigned to them, but I’d like them to complete it. Can they do this?
Yes. Anyone with a NetID can enroll and complete the training in myHRLearn. Simply have them search for “Clinical Research Workforce Excellence.”
CReWE Presentation Recordings
- Informed Consent: Not Just a One Time Discussion, presented by Marcella Oliver on October 14, 2019
- Nuts and Bolts of Clinical Research, presented by Ravi Kalhan, M.D., on November 14, 2019
- Regulatory Binders, presented by Payal Tiwari and Angela Baumgartner on December 12, 2019
- No recording of January Ask-Me-Anything session due to technical issues
- FDA Preparedness and Survival Guide, presented by Garett Griffith
- COVID-19: The Pandemic that Impacted Every Aspect of our Lives, presented by Dr. Michael Ison on April 9, 2020
- Local Single IRB Requirements and Processes (All Your Questions Answered), presented by Marcella Cooks on May 14, 2020 (partial recording)
- Research Integrity and Misconduct: Protecting Clinical Research, presented by Lauran Qualkenbush on June 11, 2020