Clinical Data Management – CDM

Clinical Data Management: Writing protocol, Study Start-up, Subjects, Randomization, Data Entry, Query, Study lock.

Interventional vs. Non-Interventional

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)

J-Review and SpotFire Comparison

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 view 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 Available (bit slower)
Date wise Patient report Available Not Available.
Graphical view Many type but still not pretty enough Better looking Graphs
Risk Assesment Available Available
Benefit Risk Analysis High level overview of benefit and risk of the trial Under construction
Baseline and Endpoints Can be defined at the study/project level by an Admin Can be defined for each report.
SAS programs Can register and execute SAS programs Not Available.
Patient Narratives Wow.. Factor! Not Available.
Multi-study analysis Can choose more than one study One study at a time.
Output Same as above. Can work and save output for multi-study One study at a time.
Setup Built based on the Clintrial and OC-like product Vanila. Tell the where the views are.

SAE Reconciliation

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.

Attachment(s):

Sample SAE Reconciliation Format.

Process workflow