Wednesday, April 26, 2017
Linda Sullivan, MCC President, and Keith Dorricott, MCC Ambassador - discussed the results of the 2016 MCC Site Data Entry Practices Survey in their article “Importance of Data Entry Timeliness” published by Applied Clinical Trials. The article reveals that organizations consider timely data entry to be very important but face challenges with measuring and monitoring the data input process. A newly released MCC Industry Practices Insight Report, “Clinical Trial Site Data Entry Study: An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies” provides industry’s perspective on the cycle time from subject visit to data entry by investigative sites, and how organizations use the performance data to improve data entry compliance.
About the Survey
MCC conducted the 28 question, web-based survey between June – August 2016. There were 35 respondents primarily from sponsors and Contract Research Organizations (CROs) both large and small. For more information on purchasing this and other MCC Industry Practices Insight Reports, please email Customer Service
or visit our Industry Practices Insights Report Page
Read Linda Sullivan and Keith Dorricott’s article on Applied Clinical Trials Online
Friday, February 17, 2017
Linda Sullivan shared her insights on the major updates to the International Guidelines for Clinical Trials in an article entitled “New GCP R2 Guideline Emphasizes Risk Management Through People, Process, And Technology” by Ann Neuer posted in Clinical Informatics News. Linda speaks on how the new update supports organizations moving to tracking and reporting critical data rather than meaningless data in clinical trials. Click here
to read the full article.
Thursday, October 20, 2016
Boston, MA., October 20, 2016
—Metrics Champion Consortium (MCC)—a trusted partner in the clinical trials industry—announced today a newly published report, “An Updated Look at Risk Assessment and Risk-based Management Practices
,’ revealing the industry’s acceptance of risk-based monitoring across all phases of clinical trials and regions. The report also features new content on the use of formal risk assessment as a tool for identifying causes of risk that could affect the collecting of critical data or the performance of critical processes prior to a clinical trial.
Among the key findings:
- Top sources organizations use for project/protocol review is EDC (83%), CTMS (66%), and Central Labs (60%)
- Majority of organizations are conducting risk assessments prior to study conduct (69%)—fewer are repeating assessments during study conduct
- Use of web portals and secure document exchange has increased to 56% in 2015, up from 36% in 2013
- Top reasons organizations are implementing RBM shifted from reducing monitoring costs-78% in 2013-to improving quality oversight (83%) and data quality (85%) in 2015
- Traditional 100% SDV monitoring decreased from 75% in 2013 to 62% in 2015
“The significant increase in the use of risk-based monitoring approaches signals that the industry has moved from the early adopter to the early majority innovation adoption phase,” said Linda Sullivan, co-founder and president at the industry group Metric Champion Consortium, author of the new report. “Additionally, our analysis shows that the data analytic approaches being utilized to support risk management and RBM programs are growing in sophistication and will continue to do so in the next 12 months. Standardizing performance metrics are the linchpin that support these analytic platforms.”
MCC conducted the online survey between November 2015 and January 2016 as a follow-up to the seminal work piloted by MCC in 2013, the first survey to examine organizational approaches and e-data sources driving risk-based monitoring (RBM) programs.
For more information on purchasing the “An Updated Look at Risk Assessment and Risk-based Management Practices,”
please email firstname.lastname@example.org
or visit http://metricschampion.org/rbm/
About Metrics Champion Consortium (MCC)
MCC—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the crucial components of what is changing and how the industry is responding to address these changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.
For more information about MCC metric sets and tools, metric education programs and how you can participate in MCC work groups, please visit http://www.metricschampion.org
Thursday, January 22, 2015