FDA Form 1572 - Guidance on the FDA's Statement of Investigator Form

 In July 2008, FDA released a draft guidance to answer frequent questions about Form FDA-1572, also called the Statement of Investigator form. A Food and Drug Administration Guidance is non-binding, but it does serve as useful information on how to interpret the agency's regulations. Keep in mind that this is only a draft; with the recent change in administration this draft may never be released as final or it may be significantly modified.

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FDA’s Bioresearch Monitoring (BIMO) Inspections

FDA BIMO inspections, Form 483 and Warning Letter

BIMO, the Bioresearch Monitoring Program, is a Food and Drug Administration (FDA) program of on-site inspections to ensure the quality and integrity of the data submitted to the agency from regulated clinical trials of investigational drugs, devices, and biologics. Inspections are made both in the U.S. and internationally at clinical investigator sites, institutional review boards (IRBs), and sponsors (e.g., pharmaceutical, medical device, and biologic companies, including monitors and contract research organizations or CR0s working under the sponsor).

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The Historical Rise of Pharmaceutical Regulation

The first rumblings for US drug legislation began after the Civil War, which had spurred the separation of drug manufacturers from drug prescribers and drug dispensers. This was the time of the traveling medicine shows selling dangerous, addictive or just non-sense patent medicines. Today's pharmaceutical companies got their start in the apothecary shops of that time, but still, most drugs were imported from Europe. In fact the U.S was a dumping ground for substandard and contaminated drugs.

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A Metric System Primer from a Overly Analytical Clinical Research Professional

 For those of you outside of the clinical research industry that don't understand all of the fancy metric terminology we research industry professionals use in our daily activities, we'll here a list.

10^12 dactyls

10^18 stentials

10^21 piccolos

10^18 minations

10^15 coats

10^12 bulls

10^12 microphones

10^12 pins

10^9 lows

10^9 antics

10^9 questions

10^6 bicycles

10^6 airs

2^10^3 millinaries

2x10^3 mockingbirds

1000 Kowalskis

10 cards

10 decor

10 dence

10 halls with boughs of holly

10 rations

3-1/3 tridents

1 centipede/second

1/2 Soviet press agency

10^-1 mate

10^-2 mentals

10^-5 dollars

10^-6 fish

10^-6 scopes

10^-9 goats

10^-12 boos

10^-15 fatales

10^-15 bismol

10^-18 boys

nano-nano (as in Mork & Mindy)

= 1 teradactyl

= 1 exastential

= 1 gigolo

= 1 examination

= 1 petacoat

= 1 terabull

= 1 megaphone

= 1 terrapin

= 1 gigalow

= 1 gigantic

= 1 gigawhat

= 2 megacycles

= 1 millionaire

= 4 seminaries

= 2 kilo mockingbird

= 1 Kilokowalski ("Killer Kowalski")

= 1 decacard

= 1 hector

= 1 decadence

= decahalls with etc.

= 1 decoration

= 1 decade

= 1 velocipede

= 1 demitasse

= 1 decimate

= 1 centimental

= 1 Millicent

= 1 microfiche

= 1 microscope

= 1 nanogoat

= 1 picoboo

= 1 femtofatale

= 1 fepto bismol

= 1 atto boy

= a prefix designating 10^-18

If you want to know how long it took me to compile all of this, well, it took a microcentury or two or three. That's about 52.5 minutes for all of you analytical Clinical Research Associate types. But, then it probably only took you a nanocentury (3.156 seconds) or so to figure out that I've been working a little too hard lately....!

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Latin Abbreviations Ad Nauseam

In case your Latin is a little rusty, here's a list of abbreviations commonly used in medical charts and prescriptions. These may be useful when monitoring medical charts, or maybe just for impressing your friends. Now, if you could only get training on how to read the awful handwriting...

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