Educational Seminar: How to Maintain Statistical Oversight during COVID-19?

Educational Seminar:

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)

Register Here

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 .

Register Here