Take advantage of our $850.00 price by registering early!
* After Friday, May 3, 2019, costs are $1050.00.
fundamental shift is occurring in the clinical research industry related to how
sponsors satisfy their regulatory and GCP requirements for the adequate
monitoring of clinical trials. Recent regulatory authority guidance and
industry initiatives are both promoting a modern approach to clinical trial
monitoring based upon program and study-specific risk assessments and
mitigation plans. In order for clinical research professionals to embrace this
industry shift, it is critical that they understand the rationale, concepts,
and actual work practices inherent in risk-based monitoring.
This course is designed
for clinical research professionals across the spectrum of research
organizations, investigational product types, and experience levels.
Participants will acquire a deeper understanding of the philosophy of
risk-based monitoring and be able to apply this understanding to operational
activities including the following:
• Performing program and
study-level risk assessments and managing risks
• Writing a risk-based
• Designing reports and
metrics for central monitoring activities
• Supporting Clinical
Research Associates for success in the new monitoring environment
• Preparing Investigators
and site personnel for risk-based monitoring
- Compare and contrast risk-based monitoring with a
traditional monitoring approach
- Identify program and study-level
- Develop a monitoring plan which
focuses on mitigating risks at both the program and study levels
- List the activities,
responsibilities, and outputs of Clinical Data Management in risk-based
- Describe approaches and techniques
for central/remote monitoring and data review
- Predict changes for
Investigators/sites as a result of wider adoption of risk-based monitoring
- Sponsors/CROs Clinical Operations Staff
- Clinical Research Associates and
- Clinical Data Management Staff
- Investigators and Staff
- Clinical Quality Compliance and Quality
The course will be led by one of the following
Marla Hoelle, R.N., B.S.N.,
Lily Romero, P.A., C.C.R.C.
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Day One: 8:30 a.m. – 5:00 p.m.
- Risk-Based Monitoring: Regulatory authority guidance, ICH GCP E6
Guideline, and industry initiatives
- Risk Assessment: Identifying critical data and risks; evaluating and
- Monitoring Plans: Considerations, content, and associated quality
- The Clinical Data Management Connection: Data management as monitoring; central monitoring
techniques and reporting
- Remote Monitoring: Strategies, tools, and responding to findings
- Research Sites and Risk-Based Monitoring: Managing change, clarifying expectations, and supporting
sites through transition
- Risk Assessment Case Study
- Design a Risk-Based Monitoring Plan
Table of Contents
- Brainstorming Clinical Data
Management Reports for Central Monitoring
- Data Trend Analysis Activity
- Site Transition Planning
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
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#: 0778-0000-17-010-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1