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2018 Agenda

2019 Agenda Coming Soon! 

Friday, September 28, 1:15 to 2:00                                          

Unique Monitoring Experiences - How to Effectively Manage Challenging Situations 

Experiential learning is pivotal in clinical research; gaining knowledge from others’ professional tenure is one of the best ways to advance an individual’s proficiency. Ms. Statler will draw upon her 9 years of monitoring experience to directly inform the topics that will be discussed. Challenging scenarios will be presented and resolutions will be offered. 809

Presenter: Abby Statler, MPH, MA, CCRP, Research Regulatory Quality Assurance Coordinator, Cleveland Clinic 

Track: Monitoring

Friday, September 28, 2:05 to 2:50     

Creating Effective Communication Strategies and Relationships with Sites in a Remote Monitoring Environment

The new focus on remote monitoring has provided sites, sponsors, and monitors with many benefits, including less travel, expense, and more real-time data review of critical endpoints. Unfortunately, the change in environment for more on-site training and monitoring can lead to strained and underdeveloped relationships between site staff and monitors. The lack of proper communication may lead to additional challenges in meeting study-related targets, additional errors, and a generally less engaged study team.  By learning how to adapt on-site communication and training practices to the remote environment, sponsors, sites, and monitors can equally benefit from a more productive and engaged study team. 811

Presenter: Grace Morgan-Holmes, BS, CCRP, CCRA, Senior CRA and Protocol Specialist, Westat 

Track: Monitoring

Friday, September 28, 3:25 to 4:10                                          

 Our Risk Based Monitoring (RBM) Model for Device Studies - A Team Approach 

BIOTRONIK uses a grading model and heat map model to determine which sites need monitor visits on a more frequent basis, as well as the regular visits dictated in the Monitoring Plan. Device data and other CRFs are centralized monitored by both in house CRAs and RCRAs. This allows for less frequent monitor visits to be dictated in the MP, as well as less on site time for the RCRA team when on site. 813

Presenters: Sarah Deer, CCRA, Regional CRA Manager, BIOTRONIK

Phil Moll, MS,  Statistical Programmer, Clinical Studies, BIOTRONIK

Track: Monitoring

Friday, September 28, 4:15 to 5:00                                          

Monitoring Plan Development and Key Considerations 

Ms. Doherty will focus on Monitoring Plans for clinical trials. Topics will include the importance of having a clear Monitoring Plan at study start and key elements of the plan, such as source data verification and escalations.  815

Presenter:  Lauren Doherty, CCRP, Clinical Trial Manager, TESARO

Track: Monitoring