Example: biology
Multicenter
Found 2 free book(s)Kerendia Prescribing Information
labeling.bayerhealthcare.comThe safety of Kerendia was evaluated in the randomized, double -blind, placebo- controlled, multicenter pivotal phase 3 study FIDELIO -DKD. In this study, 2827 patients received Kerendia (10 or 20 mg once daily) and 2831 received placebo . For patients in the Kerendia group, the mean duration of treatment was 2.2 years.
Data Quality Management In Clinical Research
oir.nih.govrandomized trial or data from multicenter research. Sponsor Monitoring – Sponsors monitor the study records and processes to ensure a well run trial is being conducted and that the data being provided is of high quality and validity. If the data is not valid, the Sponsor cannot use the data to support a marketing application before the FDA.