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.....
Showing posts with label cra. Show all posts
Showing posts with label cra. Show all posts
Sunday, January 3, 2010
Wednesday, April 15, 2009
Finalizing Standard Operating Procedures (SOPs) - PART 5
Alright. I'm back and we're going to cover the next most important step to getting Standard Operating Procedures up and running at your company or site.
Finalizing SOPs can be hazardous to your health. (lol) You can have a nervous breakdown if you don't start off controlling the situation and continue to control the situation. This is where the "REAL QA" comes out in you. The reason is "different opinions". What you have to do is remember that opinions are like eyes - everybody has one...or two....and only the VALID ones count. You must be willing to give a little to get the process moving through the system. If some one's opinion means the company will be violating a regulation, no matter how they put it, then don't agree to it. If the opinion is do-able and still meets Regulations, give in and give it a chance. If it doesn't work, you can gloat during the revision period. Remember, DIFFERENT DOESN'T MEAN WRONG!
Your biggest problem will occur if you have competitive management styles. In this case, secure a conference room and schedule a meeting with the two managers at the same time and ask them to please come to an agreement on wording so you can get the SOP approved and the company compliant. Always make it tactfully apparent that they are holding up the company's compliance program and you're only trying to keep the company out of trouble with the Regulatory Agencies. Have a solution ready before you sit down with them.
Case Study:
One manager wanted the SOP to read "Clinical Investigator sites will be chosen for an audit as determined by Clinical Operations". The other manager wanted to say "Clinical Investigator sites will be chosen based on clinical operations suggestions due to observed performance". QA can offer a solution by suggesting the sentence reads: "Clinical Investigator sites will be chosen for an audit based on decisions agreed upon by applicable management". Now, this is really a QA Management responsibility. QA should choose which sites to audit and that decision should be based on information retrieved from Clinical Operations dialogue; or something QA read in Monitoring Reports or heard at a meeting - OR....gossip overheard at the water cooler, in the restroom or cafeteria. QA's ears are ALWAYS wide open for tips on non-compliance. When you hear it, research it and jump on it before that molehill becomes a mountain.
Once you get the managers to agree on the wording, quickly close the meeting and "WALK" that SOP around that day for signatures.
Most times, your biggest holdup is going to be management. They always want to be a part of the process but is never around to sign standard operating procedures and policies. They also constantly lose the SOP on their desk or somewhere..... so try really hard not to leave with your senior management, especially if you know they have these habits. Instead, (if you can't do it), ask their assistant to help you by getting the signature and not letting the SOP out of their sight. Make an appointment if you must, but try not to leave it for them to get to later. I'm telling you - you'll thank me later!!!
Always resolve conflicts when they start or your unapproved SOP will be outdated before it get approved - which can take 6 month to a year if you let procrastinators hold you up. Don't let it happen! Take control of the situation.
Keep management's involvement to a minimum. When I say to a minimum, I'm not saying they shouldn't see the SOP or be involved in the process. THEY SHOULD DEFINITELY BE INVOLVED in the process because they are accountable. When I say keep their involvement to a minimum, I mean try to keep the number of people to sign off on your procedure to a minimum. If you don't identify in your SOP on SOPs who signs off on your operating procedures, you can end up with 2-pages of nothing but signatures and a month before the SOP is effective. You have no idea how much trouble big egos can cost! Consider keeping your approval signatures to the 1) author, 2) author's supervisor, 3)head of the SOP's applicable area and the 4) QA Manager. In cases where there are a small number of employees, (like Investigator sites or CROs), two signatures will do: the author and the head of the company or principal investigator. (The PI definitely need to sign off on ALL SOPs in their research center). The author and the approval person should not be the same. If only one person, such as the CEO of a small business writes and approves the SOPs, these should be called "policies", not "SOPs" as we know them. And this is OK because most regulation merely require you have written procedures. The instructions I'm giving here are based on "industry standards".
Once the SOP is approved, each employee affected by the SOP must be trained on it. The author can train the employees or another person delegated by management can perform training. Regardless of who perform the training, make sure they 1)know the procedure and can adequately train the staff 2) document the training, and 3) retain the training record of attendance and content.
The next thing you need to do is set up a Review Process to ensure the SOPs are current. We will discuss that in Part 6. Remember, QA is responsible for maintaining the SOPs and ensuring compliance to the SOPs. QA is responsible for tracking them to ensure they are current....next time, I'll tell you how to do that.
Until then,
HAVE A QUALITY DAY!
Sarah
Finalizing SOPs can be hazardous to your health. (lol) You can have a nervous breakdown if you don't start off controlling the situation and continue to control the situation. This is where the "REAL QA" comes out in you. The reason is "different opinions". What you have to do is remember that opinions are like eyes - everybody has one...or two....and only the VALID ones count. You must be willing to give a little to get the process moving through the system. If some one's opinion means the company will be violating a regulation, no matter how they put it, then don't agree to it. If the opinion is do-able and still meets Regulations, give in and give it a chance. If it doesn't work, you can gloat during the revision period. Remember, DIFFERENT DOESN'T MEAN WRONG!
Your biggest problem will occur if you have competitive management styles. In this case, secure a conference room and schedule a meeting with the two managers at the same time and ask them to please come to an agreement on wording so you can get the SOP approved and the company compliant. Always make it tactfully apparent that they are holding up the company's compliance program and you're only trying to keep the company out of trouble with the Regulatory Agencies. Have a solution ready before you sit down with them.
Case Study:
One manager wanted the SOP to read "Clinical Investigator sites will be chosen for an audit as determined by Clinical Operations". The other manager wanted to say "Clinical Investigator sites will be chosen based on clinical operations suggestions due to observed performance". QA can offer a solution by suggesting the sentence reads: "Clinical Investigator sites will be chosen for an audit based on decisions agreed upon by applicable management". Now, this is really a QA Management responsibility. QA should choose which sites to audit and that decision should be based on information retrieved from Clinical Operations dialogue; or something QA read in Monitoring Reports or heard at a meeting - OR....gossip overheard at the water cooler, in the restroom or cafeteria. QA's ears are ALWAYS wide open for tips on non-compliance. When you hear it, research it and jump on it before that molehill becomes a mountain.
Once you get the managers to agree on the wording, quickly close the meeting and "WALK" that SOP around that day for signatures.
Most times, your biggest holdup is going to be management. They always want to be a part of the process but is never around to sign standard operating procedures and policies. They also constantly lose the SOP on their desk or somewhere..... so try really hard not to leave with your senior management, especially if you know they have these habits. Instead, (if you can't do it), ask their assistant to help you by getting the signature and not letting the SOP out of their sight. Make an appointment if you must, but try not to leave it for them to get to later. I'm telling you - you'll thank me later!!!
Always resolve conflicts when they start or your unapproved SOP will be outdated before it get approved - which can take 6 month to a year if you let procrastinators hold you up. Don't let it happen! Take control of the situation.
Keep management's involvement to a minimum. When I say to a minimum, I'm not saying they shouldn't see the SOP or be involved in the process. THEY SHOULD DEFINITELY BE INVOLVED in the process because they are accountable. When I say keep their involvement to a minimum, I mean try to keep the number of people to sign off on your procedure to a minimum. If you don't identify in your SOP on SOPs who signs off on your operating procedures, you can end up with 2-pages of nothing but signatures and a month before the SOP is effective. You have no idea how much trouble big egos can cost! Consider keeping your approval signatures to the 1) author, 2) author's supervisor, 3)head of the SOP's applicable area and the 4) QA Manager. In cases where there are a small number of employees, (like Investigator sites or CROs), two signatures will do: the author and the head of the company or principal investigator. (The PI definitely need to sign off on ALL SOPs in their research center). The author and the approval person should not be the same. If only one person, such as the CEO of a small business writes and approves the SOPs, these should be called "policies", not "SOPs" as we know them. And this is OK because most regulation merely require you have written procedures. The instructions I'm giving here are based on "industry standards".
Once the SOP is approved, each employee affected by the SOP must be trained on it. The author can train the employees or another person delegated by management can perform training. Regardless of who perform the training, make sure they 1)know the procedure and can adequately train the staff 2) document the training, and 3) retain the training record of attendance and content.
The next thing you need to do is set up a Review Process to ensure the SOPs are current. We will discuss that in Part 6. Remember, QA is responsible for maintaining the SOPs and ensuring compliance to the SOPs. QA is responsible for tracking them to ensure they are current....next time, I'll tell you how to do that.
Until then,
HAVE A QUALITY DAY!
Sarah
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