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…
Read more
Epic gives you the flexibility to design, schedule and distribute reports. Any body has manual.. screenshot.. how to use .. etc?
IB (Investigator’s Brochure) update contains Dose (of the study drug) Frequency of dosing interval Methods of administration Safety monitoring procedures An IB contains a “Summary of Data and Guidance for the Investigator” section, of which the overall aim is to “provide the investigator with a clear understanding of the possible risks and adverse reactions, and…
Read more
Do they use this? what do they use? how do they do it? Can’t we find anything better than this? We want to come up with list of applications and companies which uses them. Here it is List of Pharmaceutical Companies. Say, Oracle Clinical – Genentech, Pfizer, Radpharm, Corelabs, Paraxel Remote Data Capture – Pfizer, Clinitrial…
Read more
(Adverse) Event of Interest: Every physician/scientist/clinician magical synopsis (or a nightmare) Analysis of Similar Event.
Provide Cumulative frequency listing for the following PTs: Renal failure LFT Abnormal Provide number of Cases for each PT, the source of that Case (clinical, Post-Marketing , etc.), and the Causality. Columns: Preferred Term, Source, Causality, Number of PTs. Renal Failure Spontaneous Related 10 Renal Failure …
Read more
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…
Read more
The Periodic Safety Update Report (PSUR) is required as part of the FDA Post Marketing Drug Risk Assessment (PMDRA) program. The PSUR report is evolving with the ICH initiatives and the February 2004 FDA Guidance for industry. Sample PSUR is attached.
Food and Drug Administration is not a Cop. Its your Mom! FDA wants to make sure you are doing the right thing. To keep the FDA in loop, you have to keep tweeting your status periodically viz. Periodic Safety Update Report (PSUR), Developmental Safety Update Report (DSUR), SUSAR, Council for International Organizations of Medical Sciences (CIOMS), Serious Adverse-event Report,…
Read more