Hi lady_express_44,

regarding case # vs. ISR...your overall impression is correct.

But just in case you want more detail...think of it this way.

1. Imagine that you take a drug and suffer a HEART ATTACK and are HOSPITALIZED on March 1, 2008.

2. Because of this, you might file an INITIAL adverse event report to the FDA that says something along the lines of "I took Drug X and I had a heart attack and was hospitalized on March 1, 2008."

3. This INITIAL report gets both a Case # **and** an ISR.

4. NOW imagine that 2 days later you died of that heart attack.

5. your spouse or MD or attorney might submit a FOLLOWUP report saying, "and by the way...we had the initial outcome as HOSPITALIZATION, but there's a new outcome of DEATH as well."

6. This FOLLOWUP report (and any other followup reports) gets the same Case #, but it gets a separate ISR #.

So...this is my long-winded way of saying Case # ties together 1 or more reports for the same patient. Each report gets a separate ISR.

Hope that makes sense!

Is the case# like an individualized "personnel" number for each client/patient, so that ANY time you get a report on a 'person', you source their previously assigned case#?
YES!

But when we look at the ISR'#s assigned to an individual case#, sometimes it "appears" that the exact same thing can be reported several times, sometimes on the same event date, but not necessarily. Does that just mean that the same event was reported that many times (from various sources?), or that these are seperate events?

This is a good question, but the answer is not clear as there do not appear to be standardized methods for reporting adverse reactions. I **think** (emphasis on think) that most often, the adverse reactions that are repeated are actually duplications, but that is not necessarily always the case.

It shows two similar "ISR #'s" under that case# (person), but in different "Quarters" (one in Q1, and one in Q2), and with only one "Event date" documented .... How would we know if that is the same "event" remitted from two sources, or two seperate events that occurred?
Again, the answer isn't clear. In *some* cases, you can probably use common sense to figure out what's going on (e.g., if esophogeal cancer is listed in 2 separate ISRs from the same case, it's likely to simply be a duplication), but this isn't always the case.


Also, where is the legend for the outcomes, like "DE" or "OT"?
DE = Death
OT = Other (i.e. not death, hospitalization, congenital anomaly or "required intervention")
If you click on the column heading labeled "Outcomes", it will pop up a small window that gives you the legend.

Hope that helps.


Best,

-tba