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Marching to the New Beat of RBM and ICH E6(R2): Data Management Leads the Band

A webinar presented for the Society of Clinical Data Managers on June 28, 2017

By Penny Manasco - June 19, 2017

The more MANA RBM implements risk based monitoring (RBM) and ICH E6(R2), the more we appreciate the importance of data management (DM) in the process.  I was pleased when the Society of Clinical Data Management (SCDM) invited me to speak on the topic of Data Management’s role in adopting the new ICH E6(R2) Good Clinical Practice Guidelines approved in 2016.  This live webinar will be on June 28 at 9:00 EST and 12:00 EST.  The cost is $420 for non-members and $360 for SCDM members.  For webinar details, here is the link: .  The registration link is
Why is this topic important to everyone?
Data Managers will be key drivers in selecting systems to meet the new needs for contemporaneous data entry, rapid review of critical data (i.e., safety, efficacy, and protocol compliance), and data analytics for more robust, integrated data review at the subject level and across sites. 
Data Managers will need the creativity and knowledge to design systems that go far beyond simply collecting data for analysis.  MANA RBM already designs the newer, robust systems to perform electronic informed consent, manage training, facilitate remote review of protocol compliance, and even do robust checks to confirm that the correct users are performing the correct assessments at the correct times and that the users have the right training and delegation to perform those activities!
Data management review should occur immediately after the subject was seen and the data entered.  There is no need to have DM wait until monitors review a subject when the data are entered directly into electronic systems (i.e., eSource). 
DM insights are critical to central review.  Instead of worrying about how many queries were closed, data managers will gain further insight into what queries have been raised and why, identify trends at sites for correctable errors, and help design systems to enhance the site’s successful participation in the trial. 
Data analytics is another key area where Data Managers can support the successful adoption of the new Good Clinical Practice Guidelines.  Here, study specific reporting to enable efficient review of critical data and processes identified during Risk Assessment is crucial to success. 

I hope you can attend this webinar.  We also invite all your colleagues or others interested in this topic to attend.
Stay tuned to our website and blogs too for some exciting RBM news.  In the works are new methods and systems that will significantly change how you conduct clinical trials and deliver cost savings you can see and take to the bank.