Sunday, January 3, 2010

Why I Love Auditing - True Stories to Make You Smile

People often say I should write a book. I doubt if I ever will, but I (in many cases along with my colleagues) have experienced some real interesting audits. I will tell you in advance that all of these tales are true. I will also tell you that any names used (other than mine) have been changed to protect the innocent - yes, some of them really were innocent.

I enjoy talking about my audits. I've never been on an audit where I haven't learned something from it. I look at audits as an opportunity to help those who want to get it right - those who are opened minded enough to learn new things instead of thinking they know it all, and as an opportunity for me to learn how other people think.

Since I started auditing, I've investigated 5 potentially fraudulent sites - 3 of them were fraudulent.

Auditing Tale #1:
The CRC documented that the subjects were taking the IP when she was in fact throwing them out. The Clinical Research Associate caught her and reported it to the sponsor. When the Clinical Research Coordinator was questioned about the deceptive act, she claimed she was upset...a good friend had died and she was so upset that she just wasn't thinking clearly. She said she had never had a subject who wasn't 100% compliant (riiight!!) in a clinical trial and when the subject returned the medication unopened, she panic and didn't know what to do. So, because of the stress from the death and work her first thought was to take the pills out that the subject was suppose to take and toss them out.

Well, all auditors know that documentation for all volunteers showing 00% compliance consistently is a red flag! You've been taking medication for three years and for every day for three years you have never missed a pill. Come On!! LOL. Well, that was only the beginning, we also found progress notes and telephone contact logs for subjects going outside the country on vacation - yet, those same subjects had vital signs at the clinic on days that they were on vacation in another country..... lol...... And the greatest one of all - more than 100 ECGs had been altered from the 1970's to match visits subjects were suppose to have had in 1980's and 1990's. They were all written over, scratched out or blacked out and the appropriate visit date written on the ECG. When asked about the dates being changed the CRC stated their ECG was unable to hold the current date. Well, I gotta tell you - if you have an ECG machine that changes the month, day and year 3-4 times in one week..THROW IT OUT!!!!! lol

Yes, somebody reported it to the FDA. No, they never investigated.

Until next time.....

HOT RESEARCH TOPICS!!


How to Videos & Articles: eHow.com