How to Maintain Statistical Oversight for Current and Future Clinical Trials during COVID-19
Wednesday, June 3, 2020 1:00 pm
Eastern Daylight Time (New York, GMT-04:00)
The FDA has been issuing updated guidance as the crisis continues including recommending the use of central and remote monitoring programs to maintain oversight of clinical trials as planned on-site monitoring visits are no longer possible.
During this session we will:
1. Show how to utilize supervised and unsupervised methods to analyze the results of central and remote monitoring programs. We will demonstrate how to:
· Set Risk thresholds to find high risk sites that may require further investigation
· Identify Safety or Enrollment related Risk Indicators
· Identify Data Outliers or Anomalies (duplicate records, bias in digits or findings)
· Examine Enrollment Patterns or patient recruitment assessment to original deadline
· Statistically analyze variables derived from the EDC such as number queries, # of missing eCRF’s.
2. Explore how and why the FDA has made JMP Clinical a required part of the medical reviewer training process.
Please forward invite to colleagues and friends from other organizations who may be interested .