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)
JReview and SpotFire Comparison:
Graphic Patient Profile
End-User can create on the fly.
Require IT Support help
Patient Review Tracking
Keep track of patients reviewed.
Tabular Patient Profile
Spreadsheet-view with ‘New Data’ hightlights
Formated Patient Profile
PDF-view. Similar SAS output. Can be scheduled as Batch-run
Can view Graph and Spread-sheet view of patient(s)
Better than Jreview’s view. But requires IT support help.
SAS as Data Source
Available (bit slower)
Date wise Patient report
Many type but still not pretty enough
Better looking Graphs
Benefit Risk Analysis
High level overview of benefit and risk of the trial
Baseline and Endpoints
Can be defined at the study/project level by an Admin
Can be defined for each report.
Can register and execute SAS programs
Can choose more than one study
One study at a time.
Same as above. Can work and save output for multi-study
One study at a time.
Built based on the Clintrial and OC-like product
Vanila. Tell the where the views are.
Posted in: Clinical Data Management - CDM, Drug Safety and Pharmacovigilance - DSPV, I-Review, J-Review, Listings and Reports, Listings and Reports, SpotFire
Tagged: JReview, Jreview Vs. Spotfirel, Spotfire, Spotfire Vs. JReview, Why sportfire is better?
Frequency by System Organ Class:
SOC, PT, Count of PTs
Oh Oh! that’s what you hear from the folks who does the Serious Adverse Event Reconciliation. Fight (and politics) between the DM and PV never could reconcile. So does the SAE Reconciliation.
Hospitalization but Resolved. – DM said
Nooo, it wasn’t. Onset of Renal Failure is after Prior Dose. – PV denied.
Six categories of Serious Adverse Events (SAE)
AECAN -ae cancer
AECONG – ae congenital anomaly or birth defect
AEDIS – ae disability (significant
AEDTH- ae death
AELT – ae life threatening
AEHOSP- ae hospitalized
If AE is marked Serious, it suppose to fall under any these 6 category.
Sample SAE Reconciliation Format.