Non-Interventional Study = Medicinal product is prescribed in the usual manner (Example: Acetaminophen only) Interventional Study = Participants are assigned to receive one or more interventions so that researchers can evaluate the effects of the interventions. (Study medication (Acetaminophen ) with Cantaloupe juice and Aspirin)
These disease areas are NOT in order. Alzheimer’s Asthma Bi-polar Disorder Breast Cancer Cardiovascular Cardio Vascular Imaging Chronic Hepatitis C COPD Diabetes Diabetic Kidney Disease Dyslipidemia General Anxiety Disorder Influenza Major Depressive Disorder Multiple Sclerosis Pain Parkinson’s Disease Polycystic Kidney Disease Prostate Cancer QT Studies Rheumatoid Arthritis Schizophrenia Traumatic Brain Injury Tuberculosis Virolog
What is BI Publisher? Its a component of OBIEE (Oracle Business Intelligence Enterprise Edition) where a developer can create a layout (just the layout) for complex-layout report. Examples: The following report has two totals at the bottom. This is simple, why to use BI publisher for it? Well, its just an example of Row-level columns.…
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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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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 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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At the logon screen, click the ‘Advanced’ button and check the ‘Debug’ checkbox. Log in as you would normally, and perform the series of steps in reproducing the issue. Log out of JReview. Restart the JReview client. DO NOT LOG IN. Click the ‘Advanced’ button then click the ‘Bundle Server/Client Logs’ button. This will prompt…
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Epic gives you the flexibility to design, schedule and distribute reports. Any body has manual.. screenshot.. how to use .. etc?