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Quote from brad on July 12, 2022, 1:25 pmSo I'll post updates here as I have the time.
Here is some background:
-Surgical trial with implanted device
-We were the top enroller by far even though we came in as an add-on site (lots of interesting lessons learned that may be good for other posts)
-Sponsor has been super involved throughout the whole trial (in both good and bad ways)
-PI is .... a difficult fella
-Sponsor has literally had monitors here 3 days/month for the last 18 months
The assumption is that we are going to be selected for a true FDA audit so the sponsor is bringing in an ex-auditor and putting us through the paces. I'll update as I am able.
So I'll post updates here as I have the time.
Here is some background:
-Surgical trial with implanted device
-We were the top enroller by far even though we came in as an add-on site (lots of interesting lessons learned that may be good for other posts)
-Sponsor has been super involved throughout the whole trial (in both good and bad ways)
-PI is .... a difficult fella
-Sponsor has literally had monitors here 3 days/month for the last 18 months
The assumption is that we are going to be selected for a true FDA audit so the sponsor is bringing in an ex-auditor and putting us through the paces. I'll update as I am able.
Quote from brad on July 12, 2022, 3:56 pmOff to a fairly boring start. The sponsor has a team of 5 here with their ex-FDA auditor. We started with a fairly long meeting with them and the PI. The auditor is actually being very open and it's clear that the goal is to learn and shore up any issues prior to an anticipated true FDA audit. They're starting with a random sampling of binders along with IRB/Reg binder. They have very specifically asked for "correspondence" which I find interesting and there seems to be some emphasis on this.
Nothing exciting to report yet.
Off to a fairly boring start. The sponsor has a team of 5 here with their ex-FDA auditor. We started with a fairly long meeting with them and the PI. The auditor is actually being very open and it's clear that the goal is to learn and shore up any issues prior to an anticipated true FDA audit. They're starting with a random sampling of binders along with IRB/Reg binder. They have very specifically asked for "correspondence" which I find interesting and there seems to be some emphasis on this.
Nothing exciting to report yet.
Quote from brad on July 12, 2022, 8:11 pmMost of the findings have been pretty insignificant and more related to CRAs making/asking us to do dumb things.
The sponsor hired 2 contract CRCs to assist us (CRAZY and dramatic story that I would love to cover some other time) at two different points in the study. They were absolutely terrible and didn't last long. They never signed and dated their CVs in the reg binder. The CRA asked us to write a note to file to address it. The auditor was like "there is no regulation that CVs have to be signed". Don't draw attention by adding a note to file. Good advice.
We also had some duplicate training logs (also at the request of the CRAs). The dates did not match for my personal training log and the training attendance that the CRA provided so that was another CRA-provoked mistake that we didn't pay close enough attention to. Ultimately, I understand it's on us and not the CRA but it's a pretty good lesson that is emerging: don't just take your CRAs word for it. They are often trying so hard to cover their asses that they are actually creating more issues.
A lot of this study was run by a relatively new CRC at our site so it's been a good learning experience so far. She's learning how, when and why to push back on CRA requests. Nothing too crazy observed so far but about to meet again and have a bigger debrief for the day so I'm sure there will be more to discuss.
Most of the findings have been pretty insignificant and more related to CRAs making/asking us to do dumb things.
The sponsor hired 2 contract CRCs to assist us (CRAZY and dramatic story that I would love to cover some other time) at two different points in the study. They were absolutely terrible and didn't last long. They never signed and dated their CVs in the reg binder. The CRA asked us to write a note to file to address it. The auditor was like "there is no regulation that CVs have to be signed". Don't draw attention by adding a note to file. Good advice.
We also had some duplicate training logs (also at the request of the CRAs). The dates did not match for my personal training log and the training attendance that the CRA provided so that was another CRA-provoked mistake that we didn't pay close enough attention to. Ultimately, I understand it's on us and not the CRA but it's a pretty good lesson that is emerging: don't just take your CRAs word for it. They are often trying so hard to cover their asses that they are actually creating more issues.
A lot of this study was run by a relatively new CRC at our site so it's been a good learning experience so far. She's learning how, when and why to push back on CRA requests. Nothing too crazy observed so far but about to meet again and have a bigger debrief for the day so I'm sure there will be more to discuss.
Quote from brad on July 12, 2022, 10:52 pmDay 1 in the books. Mostly regulatory review. Big emphasis on screening logs though ours were in great shape.
We had some training logs and a protocol signature page that were signed by the sub-I and PI, respectively, much later than they should have been. We were able to corroborate via emails that these documents had been sent to and reviewed by the study team at much earlier dates so we were able to note the signature dates as "late entries" and ensure the actual training/receipt dates were much earlier than the signature dates.
We were very heavily questioned on our ICF process and were able to pass through that without much issue.
We were encouraged to provide more details on our ICF process worksheet in terms of what specific questions the patient may have had or if they were accompanied by anyone at their visit
Overall, it was fairly uneventful and we were able to correct some minor issues.
I anticipate they will be digging in to the 80+ patient charts tomorrow so I expect a lot more findings.
Stay tuned.
Day 1 in the books. Mostly regulatory review. Big emphasis on screening logs though ours were in great shape.
We had some training logs and a protocol signature page that were signed by the sub-I and PI, respectively, much later than they should have been. We were able to corroborate via emails that these documents had been sent to and reviewed by the study team at much earlier dates so we were able to note the signature dates as "late entries" and ensure the actual training/receipt dates were much earlier than the signature dates.
We were very heavily questioned on our ICF process and were able to pass through that without much issue.
We were encouraged to provide more details on our ICF process worksheet in terms of what specific questions the patient may have had or if they were accompanied by anyone at their visit
Overall, it was fairly uneventful and we were able to correct some minor issues.
I anticipate they will be digging in to the 80+ patient charts tomorrow so I expect a lot more findings.
Stay tuned.
Quote from brad on July 13, 2022, 3:09 pmHaving to deal with an SSV across town for a while today so Day 2 updates may be a bit later in the day. The fun never stops.
Having to deal with an SSV across town for a while today so Day 2 updates may be a bit later in the day. The fun never stops.
Quote from Guest on July 13, 2022, 7:22 pm1) Have you been audited before? If so, what would you do the same/differently based on that previous audit?
2) What is the general approach when FDA is at your site? I’ve heard mixed things… depending on the auditor you get it can be a good experience or completely terrible
- In my estimation when the FDA is on-site it doesn’t seem to be a collaborative exchange (never having been through an FDA audit myself)
1) Have you been audited before? If so, what would you do the same/differently based on that previous audit?
2) What is the general approach when FDA is at your site? I’ve heard mixed things… depending on the auditor you get it can be a good experience or completely terrible
- In my estimation when the FDA is on-site it doesn’t seem to be a collaborative exchange (never having been through an FDA audit myself)
Quote from brad on July 13, 2022, 7:52 pmQuote from Guest on July 13, 2022, 7:22 pm1) Have you been audited before? If so, what would you do the same/differently based on that previous audit?
2) What is the general approach when FDA is at your site? I’ve heard mixed things… depending on the auditor you get it can be a good experience or completely terrible
- In my estimation when the FDA is on-site it doesn’t seem to be a collaborative exchange (never having been through an FDA audit myself)Would certainly love to hear others chime in here as well.
It's been a long time since I have been through a real deal FDA audit. This is much more collaborative than a true FDA audit. I honestly expected them to come in and try to more closely mirror an FDA audit but it's clear that the goal is more to help shore up everything prior to an expected audit, but with the lens of an ex-auditor at the helm.
The auditor here has given us some good advice that is pretty intuitive. Answer questions directly and don't necessarily offer any additional information. Keep it direct and concise. Auditors are often trained on how to interrogate people and will leave long awkward spaces that often prompt people to start speaking unprompted and opening cans of worms that could have remained closed had you kept your mouth shut.
She also referred to this guide which basically tells auditors what to do on site which is really useful if you are a site a want to know what to expect and prepare accordingly: https://www.fda.gov/media/75927/download
Quote from Guest on July 13, 2022, 7:22 pm1) Have you been audited before? If so, what would you do the same/differently based on that previous audit?
2) What is the general approach when FDA is at your site? I’ve heard mixed things… depending on the auditor you get it can be a good experience or completely terrible
- In my estimation when the FDA is on-site it doesn’t seem to be a collaborative exchange (never having been through an FDA audit myself)
Would certainly love to hear others chime in here as well.
It's been a long time since I have been through a real deal FDA audit. This is much more collaborative than a true FDA audit. I honestly expected them to come in and try to more closely mirror an FDA audit but it's clear that the goal is more to help shore up everything prior to an expected audit, but with the lens of an ex-auditor at the helm.
The auditor here has given us some good advice that is pretty intuitive. Answer questions directly and don't necessarily offer any additional information. Keep it direct and concise. Auditors are often trained on how to interrogate people and will leave long awkward spaces that often prompt people to start speaking unprompted and opening cans of worms that could have remained closed had you kept your mouth shut.
She also referred to this guide which basically tells auditors what to do on site which is really useful if you are a site a want to know what to expect and prepare accordingly: https://www.fda.gov/media/75927/download
Quote from brad on July 13, 2022, 10:03 pmDay 2 is actually pretty boring. They want to hold off and go over more findings tomorrow so they can get through more patient binders.
Only a couple of interesting observations: we had some protocol deviations for a single visit that were all recorded as separate deviations. We were instructed to record them as one deviation and elaborate more in the description.
Example - PD 1 - EQ5D not done; PD2 - BID not done; PD 3 - Pain Scale not done; PD 4 - Other Quality of Life Scale not done
Should instead be PD 1 - Scales not completed - subject did not complete EQ5D, etc etc
Usually this is how I do things but one of our less experienced coordinators was goaded in to changing it by, guess who, a CRA...
Seeing a theme here. I realize more and more that we really have to be vigilant at the site level and not just accept what we're told by our monitors. More tomorrow...
Day 2 is actually pretty boring. They want to hold off and go over more findings tomorrow so they can get through more patient binders.
Only a couple of interesting observations: we had some protocol deviations for a single visit that were all recorded as separate deviations. We were instructed to record them as one deviation and elaborate more in the description.
Example - PD 1 - EQ5D not done; PD2 - BID not done; PD 3 - Pain Scale not done; PD 4 - Other Quality of Life Scale not done
Should instead be PD 1 - Scales not completed - subject did not complete EQ5D, etc etc
Usually this is how I do things but one of our less experienced coordinators was goaded in to changing it by, guess who, a CRA...
Seeing a theme here. I realize more and more that we really have to be vigilant at the site level and not just accept what we're told by our monitors. More tomorrow...
Quote from brad on July 14, 2022, 4:23 pmDay 3 is off and we're definitely getting beat up a lot more than the previous 2 days.
We enrolled about 20% of the subjects for this trial and account for about 13% of the protocol deviations. This seems fairly in line with expectations but the auditor expressed that we had far too many "out of window" protocol deviations. Not much we can do about that but we didn't do the best job of documenting corrective actions for these repeated PDs. It looks like I'll probably be going back and doing a fair amount of clarification when it comes to these PDs.
Sort of surprisingly, the auditor went back and looked at our Facebook account for any advertising related to the study. We had made some sort of generic informational posts about the study indication and she didn't give us too hard of a time about it but it makes me think working with a third party is smart if you aren't getting every little thing IRB reviewed.
More to come...
Day 3 is off and we're definitely getting beat up a lot more than the previous 2 days.
We enrolled about 20% of the subjects for this trial and account for about 13% of the protocol deviations. This seems fairly in line with expectations but the auditor expressed that we had far too many "out of window" protocol deviations. Not much we can do about that but we didn't do the best job of documenting corrective actions for these repeated PDs. It looks like I'll probably be going back and doing a fair amount of clarification when it comes to these PDs.
Sort of surprisingly, the auditor went back and looked at our Facebook account for any advertising related to the study. We had made some sort of generic informational posts about the study indication and she didn't give us too hard of a time about it but it makes me think working with a third party is smart if you aren't getting every little thing IRB reviewed.
More to come...
