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The Adventures of SuperMonitor

A Bedtime Story for the Young Clinical Research Associate.

Second only to being a father to my son, the most important and fulfilling job I’ve ever had was being a Clinical Research Associate (CRA). Monitoring a study, like parenting a child, is a tremendous responsibility. When you are a Clinical Research Associate, millions of people — or perhaps that one innocent child — depend on you to ensuring the study integrity, so that only safe and effective products reach the marketplace.

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Committed to the Quest

… or Why I Became a Clinical Research Professional.

It all started because of a commitment I made when I was too young to understand into what I was getting myself. My mother had headaches, you see. Not the usual “throbbing-in-the-temples” kind of headaches, but the “gut-wrenching, totally incapacitating, rip-the-carpet-out-with-your-bare-hands” kind of headaches. Migraine, cluster headache, trigeminal neuralgia—whatever the flavor, they were bad. Really bad.

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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In July 2008, FDA released a draft guidance to answer frequent questions about Form FDA-1572, also called the Statement of…
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Clinical Trial Accrual Hampered by Many Factors

In recent years, cancer patients are more knowledgeable and willing to participate in clinical trials, but issues pertaining to physician…
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Clinical Research Regulation: FDA vs. ICH

On May 9th, 1997, the US Food and Drug Administration (FDA) published in the FEDERAL REGISTER (vol. 62, No 90),…
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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…
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Time Management for the Research Professional

It's been said that a pharmaceutical company loses $1 million for every day of delay during clinical research and development.…
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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.…
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Surviving an FDA Inspection of Your Clinical Trial Site

The Investigational New Drug (IND) regulations went into effect in 1963. Ever since, the U.S. Food and Drug Administration (FDA)…
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Consulting is an Art

...or Why I'm Not a Singing CRA. During those confusing and wondrous years, when a young man ponders his career…
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Illuminating the Diagnosis of Intracranial Hematoma

Without urgent pressure-relieving surgery, the chance of survival drops quickly for head trauma patients having a severe intracerebral hematoma (bleeding…
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FDA’s Bioresearch Monitoring (BIMO) Inspections

BIMO, the Bioresearch Monitoring Program, is a Food and Drug Administration (FDA) program of on-site inspections to ensure the quality…
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