Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.
Detecting Risk Signals in Protocols, Data, and Monitoring
Upcoming Courses
In an environment where remote monitoring and management techniques are becoming the daily practice, preventative measures need to be implemented to identify risks. You need to be able to identify protocol data thresholds and parameters for risks to establish management and escalation triggers. As data becomes available in real time, you should not be waiting until deviations become a “trend” before intervention is implemented; we need to know how to look for outliers and “red flags” on a daily basis. With increasing use of CROs and vendors, it is essential that best practices are established for identifying risk signals in management and monitoring practices. This course will discuss how to detect risk signals in protocols, data, and monitoring based on risk-based quality management, industry guidances, and practical application. This one day course will include hands-on activities centered around identifying and implementing preventative measures in a sample protocol, communication and management techniques, and plan development.
- Describe quality risk management and regulatory expectations based on industry and international guidance
- Apply proactive quality management techniques through signal detection and training for operational and scientific management of clinical trials
- Identify key risk factors, thresholds, and issues in protocols, reports, and data listings
- Apply signal detection techniques and preventative measures through hands-on application
- Clinical Research Associates
- Project Managers
The course will be led by one of the following instructors:
Nikki Christison, B.S., C.C.R.A.
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- Introductions
- Regulatory Environment and Risk Management
- Review regulatory trends and risk analysis applications
- Detection of signals and categories
- Proactive Management
- Identify operational and scientific risks through metrics, data, and reports
- Analyze and apply management techniques to source of risk at site, CRA, manager, and CRO level
- Facilitation of instructional methods and training practices to ensure transference and application of knowledge.
- Root Cause Analysis and CAPA in signal detection
- Apply techniques for identifying the cause for risk signals
- Manage risk through practical application of correction and prevention
- Evaluate "agile theory" as a preventive method of management
- Workshop: Hands-on Analysis and Application
- Review sample protocol to identify potential risks, thresholds for management of data, strategic interventions, and escalation requirements
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
Click here for our seminar cancellation policy
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-15-026-L01-P. Released 3/15.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.
