Cumulative frequency listing by PTs

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       Phase II              Unrelated 2

 

 

 

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

Why Clinical Reporting Service?

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, (SAR), blah..blah.

Shall we talk how to keep FDA happy. Eventually she would pay for our college fund 😉

This webpage dedicated to people who creates and submits reports for FDA. Although people who creates these listings never get to see the actual report that goes to the FDA, but these report creators are the back-bone of “Submission Group” and “Clinicians”