This three-day intensive training program was designed to meet the needs of coordinators who have less than one year of experience or who have never received formal training. It is useful to anyone who requires a fast, thorough introduction to clinical research trial conduct, Good Clinical Practices (GCPs), and the federal regulations governing research. The class is geared toward providing practical information to get students "up and running" in the clinic, with many tools and templates to assist with study implementation. Classes are typically limited to eight students to ensure that each student receives individualized instruction suited to their levels of experience. The course fee includes all materials, and students completing the course will receive 24.0 hours of CE credit. Please note that completion of this course will not provide students with certification as a CRC. One to two years of full-time work experience in the field are required before an individual is eligible to sit for the CRA or CRC certification exams. - Informed Consent
- Clinical Trial Initiation and Budget Negotiation
- FDA Forms and Procedures
- Regulatory Documents and Binder Maintenance
- Source Documents
- Study Initiation and Close-Out Visits
- Subject Recruitment, Compliance and Retention
- Drug Compliance, Storage, and Documentation
- IRBs, IRB Submissions, and HIPAA
- Adverse Events and Safety Monitoring
- Quality Assurance Audits and Monitor Visits
- Preparing for FDA Audits
This course is approved for 24.0 contact hours by the Illinois Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. Classes are held on Northwestern University's Chicago campus in downtown Chicago, Illinois, at Abbott Hall, 710 North Lake Shore Drive. Driving directions to Northwestern's Chicago campus are available here. A map with details of the course location and parking garages is available here. Classes are held from 8:30 a.m. to 5:00 p.m. each day for three days, Monday through Wednesday. A lunch break is scheduled each day. 2008 Course Dates | January | 7-9 | January | 21-23 | February | 4-6 | March | 3-5 | May | 5-7 | June | 9-11 | July | 7-9 | August | 11-13 | September | 8-10 | October | 13-15 | November | 10-12 |
Regular Rate: $995 per person. Discounted Rate: $750 per person. This discount is available to individuals who are directly employed by Northwestern University, Northwestern Memorial Hospital, Evanston Northwestern Healthcare, Children's Memorial Hospital, the Jesse Brown VA Medical Center, Prentice Women's Hospital, or the Rehabilitation Institute of Chicago. Due to the limited class sizes, payment must be received before registration can be confirmed. Payment should be made via check, money order, Visa, or Mastercard at least 5 working days prior to the course start date. Note: Although NUCATS has accommodated individuals in the past by accepting a letter from a manager or organization as proof of payment, we will not be continuing to offer this service. We must receive payment from students in advance of the course start date, and employers can reimburse students directly as needed. If the employer will ONLY reimburse NUCATS for the course and not the student, please contact our office to make special arrangements. On-site and customized sessions of this course can be scheduled at your institution. In addition to an experienced instructor, institutions booking a special session of the course will be provided with manuals and textbooks for all students. For more information and pricing, please contact our Office of Education and Training at 312-503-7952 or at nucats-ed@northwestern.edu. Canceled registrations will be charged a $100 administrative fee. No refunds are available after the course begins. Northwestern reserves the right to cancel any course with insufficient enrollment 10 days prior to the class start date. In such cases, all fees are refunded. You can register for this course online by clicking here. If you have any questions regarding registration, please contact us at 312-503-7952. If you have any questions, or if you would like more information, please contact us at nucats-ed@northwestern.edu or call our Office of Education and Training at 312-503-7952.
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