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.....

Writing SOPs - Part 4

Before I get started with the next session on Writing SOPs, I want to tell you about a new cyber-friend. I want you to check out http://leadcra.blogspot.com/. Nadia has a wealth of information on her blog discussing the Ins-and Outs of a CRA. Most interesting is the topic on transitioning from Coordinator to CRA. I get a lot of questions about that and even though I've never been a CRA, I attempt to answer it. I think a person with experience can tell you more, so check out her blog. Join as a follower, ask questions and share your experiences, too.

Now, BACK TO WRITING SOPS!!!! I think I have given you enough time to create the PROCEDURE section (or body) of the SOP and to format it to your liking. You do not have to keep the style I'm showing here. Create one of your own. Maybe you want your Responsibility section to be one paragraph and a single statement that all employees are required to follow written procedures and all managers are responsible for appropriate implementation. Develop your style and move forward.

Now, some SOPs are complicated and need a flow chart so if this is the case, create the flow chart for our SOP and label it Attachment 1. If you need a sample checklists, create one and label it Attachment 2 and so forth. When you are through, circulate the procedure to peers for comments. Give them a specific date to return the procedure to you. Review their comments for relevancy. If relevant, edit, change or add to your procedure.

Next time, we will discuss the finalization process!

Until then,

Have a QUALITY day!

Sarah

Writing SOPs - Part 2

In our last session, we created the first part of the SOP, which was the header. (See Part 1 if you haven't done that part yet). Today we are going to start on the 2nd major section of the SOP. This section consists of the Purpose, Scope, Background, Defintions and Abbreviations, and applicable Attachments.

Under the heading "Purpose", describe what the SOP is going to do. Hopefully, it will tell the reader the reason they are performing a task and how to do it.

The next paragraph in this section will be the SOP's "Scope". The scope describes the guidelines, regulations, internal procedures or protocol the task must adhere to. These will be the same criterion used to audit the task for compliance.

The "Background" section is optional. I use the background section to explain basic information about a task - if it is needed. If you are working with novices, the background section comes in handy to help them understand why they are performing the task and why they are performing it a certain way. If your co-workers are experienced people, the background section might not be necessary.

Definitions and Abbreviations are important when you write your SOP with non-standards. For example, everybody in the industry should know what FDA stands for so it is not necessary to put that in the definitions and abbreviations section. However, not everybody knows what WQATS stands for, so it is important to define "WQATS" as "Wilson Quality Auditing & Training Services" in the procedure. Always define abbreviations and terms that are used mostly at your company but not in the industry.

Attachments will be templates or diagrams used to guide the the user in completing the task. Since processes tend to change in the clinical research industry, many companies make templates a "sample" instead of a "100% controlled document". When I say "100% controlled document, it means certain sections and the format remains the same but content can change to match the intended process.

That's it for this session. Complete this part of your SOP. If you have questions on this process and what we've covered thus far, hit me up in the comments section.

Until next time..................

Have a QUALITY Day!!

Sarah

QA Talk - A Year of Change

Happy New Year Everyone!

As 2009 opens, we embrace a year of change and it could not have come at a better time. The economy is a state I would never have expected in my life time. Many colleagues are employed and either can not find work or cannot find work in an environment that will make them happy. Most of America's management continue to have the micro-management mentality where they must see you in the "central" office because they can't monitor your comings and goings if you are home based. Other managers are smart enough to know that it can be an enormous savings for both the company and the employee to have home-based workers. It would be great to see more managers move in that direction, which would save on fuel and time loss sitting in traffic.

Many colleagues have gone the independent route. I urge you to stay abreast of industry current standards. Consider taking online courses at http://www.wqats.com/Training.html. They are affordable and readily available.

The FDA offer several podcast for us to better understand their view about cerain industry practices. Check it out at http://www.fda.gov/cder/drug/podcast/Unapproved_Drugs_ReachMD_DrWoo.htm. Also, check out the new guidances, especially the one on handling information obtained from subjects who have withdrawn or was terminated from a clinical study.

The FDA have now partnered with WebMD to help consumers have even more access to vital information. They have announced that there are about 25 weight loss pills that could be harmful to the public. Web MD can now help them get this information out to the public by showcasing it on their website and in their magazine.

QA Talk

As the unemployment rate in America continue to rise, professionals are exploring opportunities to gain an edge in the interview arena. I'm glad to see this because that means more professionals are realizing the importance of certifications, training and experience. These items are extremely important and the competition out there is fierce! There are a lot of jobs availble in the UK for CRAs. Do you know enough about clinical trials in the UK to work there?

We should always get ready by enhancing our knowledge of research in other countries. Most sponsors conduct multi-centered and multi-cultural clinical trials anyway. Think outside your box. If you spend most of your time working with drug clinical trials, learn something about drug manufacturing and the entire process. At a minimum, you should have a snapshot view of that drug from "development to market". Diversify your knowledge. If you are a CRA, learn what a CRC does. You are probably not there only client so build a relationship with them and learn what a typical CRC day look like. CRC and the PI should take time to learn about the sponsor side of the clinical trial. Find out what happens to all of that data you collected. Diversification is more important than ever, now. I remember when I would go to a training session, the minute the time came to discuss device or tissue practices; I would leave. Not anymore. I want to know about it. I might find myself working in that field someday.

The more I learn now, the better for me later.

What about you? Are you diversifying your experience, your training, your knowledge? I would love to hear about it! Hit comments below and let us know about it.

Until next time......

Have a Quality day!!!