What is Argus Analytic? Its a reporting environment for Argus safety application. Oracle integrated the OBIEE (Oracle Business Intelligence Enterprise Edition) an Oracle report development tool with Argus application for reports creating and publishing. Drag and drop User interface lets the User choose the column needed to build a simple report. Complex reports (meaning the output…
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Empirica Signal and Topics: Long topic… in a nutshell, use “Empirica Signal and Topics” application (hosted by Oracle) to find Safety Signal in the FDA’s AERS data and WHO Vigibase data. Create a topic (Example. To find “fabriel neutropenia” in Oncology_Drug_1) Search for Signals Track the signal Share the signal with your group for review and comments.…
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JReport – A Business Intelligence Visualization Tool
JReview Server error: Type 0 panel referenced, but no JOIN LOGIC has been defined Solution: recreate the report from scratch. Because: You created an importsql with Expected Frequency 0 Not patient related. Created a report. You added more column(s) in the import sql and changed the Expected Frequency to > 0. You tried adding more columns…
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What is NOS in MedDRA Preferred Terms? Why do they use it? Example: Abdominal hernia NOS Abdominal hernia NOS gangrenous Abdominal hernia NOS, obstructive Blood alkaline phosphatase NOS Blood alkaline phosphatase NOS abnormal Blood alkaline phosphatase NOS decreased Blood alkaline phosphatase NOS increased Blood alkaline phosphatase NOS normal Why do they do it?
What is (in remission) in MedDRA Preferred Terms? Example: Chronic myeloid leukaemia (in remission) Chronic myelomonocytic leukaemia (in remission)
End Point: Phase 1 Primary End Point is Safety Phase 2 End Point is Efficacy Phase 3 End Point is Efficacy with fewer Mortality. Phase 4 End Point is Efficacy – Post-Marketing or Spontaneous reports. Baseline: Coming up….
What is Suspected Unexpected Serious Adverse Reaction (SUSAR)? An “Unexpected” Serious Adverse Event “Related” to the Study Drug. You got to send the CIOMS to the Health Authority. What is DSUR or PSUR or PBRER? Coming up…….
JReview and SpotFire Comparison: Feature Jreview Spotfire Graphic Patient Profile End-User can create on the fly. Require IT Support help Patient Review Tracking Keep track of patients reviewed. Not Available. Tabular Patient Profile Spreadsheet-view with ‘New Data’ hightlights Not Available. Formated Patient Profile PDF-view. Similar SAS output. Can be scheduled as Batch-run Not Available. Patient…
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How to pass user-enterd (Parameter) values in to JReview ImportSQL? 1) Add &PromptText (for number) or ‘&PromptText’ (for Char and Date) Select Study, Site, Patient, SubjInit, Sex, Race from DM Where Sex = ‘&EnterSex’ Bug: You cannot add succeeding “another Where clause” or “space” or “Enter key” after the ‘&prompt’. Where sex = ‘&EnterSex’…
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