Inspection Perspective: Tales From a Recent FDA Inspection

In a business niche as highly critical, closely scrutinised and heavily regulated as pharmacovigilance it remains a puzzle why clinical development organisations struggle so often with the “end of process task” of distributing Safety Reports*. These are commonly known as Suspected Unexpected Serious Adverse Reaction or SUSARs. Timely safety report distribution is important because of its part in improving patient safety but also due to the compelling regulatory obligation to distribute this material promptly.

A Pharmacovigilance Process Summary

  1. Site reports Serious Adverse Reaction (SAR) within 48 hours.
  2. Sponsor determines if SAR is unexpected or not.
  3. Sponsor reports SUSAR to relevant regulators within days (for EMA within 7 days and typically 15 days for the FDA).
  4. In parallel to step 3 the sponsor has a responsibility to promptly inform other sites once the matter is identified as a safety issue. While there is some scope for interpretation here, “promptly” is normally interpreted as meaning a number of days and not some longer period of time. Typically sponsors will aim to distribute safety reports within 15 days.

For reference here is how the FDA explain things – p16 of FDA Guidance Safety Reporting Requirements for INDs and BA/BE Studies.

The reality is that this end of process task sounds simple to define but it is in fact pretty complex and time critical. In addition – organisations are often so blindly addicted to using email that alternative, more dynamic and reliable means of information distribution are strangely alien and fantastical. But why not use distribution means that allow for active information distribution, with real-time dynamic readership information? In an age where audience behaviour is closely tracked, isn’t it time you knew who has read your latest Safety Report, and more crucially who has not?

The expectations of regulatory inspections are rising – requirements are getting tighter and sponsors are expected to make better use of their systems and data. In our Inspection Perspective: Tales From a Recent FDA Inspection session from the Take a New Perspective on Compliance series, Lorne Cheeseman, Senior Director Quality, at various Biopharma shared his relevant experience from hosting an FDA inspection in 2019. Below is a recap from the Q&A portion of this webinar. We hope you find Lorne’s insight on how to overcome rough monitoring and documentation situations helpful when planning for inspections.


Senior Director Quality

Various Biopharma

Adam Wood: What are some lessons learned from past inspection experiences that you can generalize or share with the audience?

Lorne Cheeseman: I think two conclusions I would draw are firstly, always be thinking about inspection readiness. You don’t know when an inspection is going to happen and you want to be as ready as you can be. It’s an ongoing process. We were lucky in that we were able to  get things in order, but if the inspection had come sooner it might’ve not gone as well. Secondly, the other thing is to know your content and in a small study, that’s easy, you’ve got a few people, but make sure that the story is captured. Adam, you alluded to things like storyboards for issues, walk through and know the content so that as the inspector’s requesting things, you’re able to pull that information efficiently and present it to them. But also as they have questions, the story is clear and you’re able to speak to the story in a clear and concise way, so that they understand how things happened. So know your content and always be putting things in inspection readiness order as you go.

Adam Wood: A question about TMF distribution and in how many different places were there bits of your TMF, obviously myClin was one, but how many other places did you draw assets or content from?

Lorne Cheeseman: So this is kind of the cool thing about how we use myClin, at the time of the inspection, everything at the site was in myClin so we were able to access it remotely from the site. So the site had started off with a paper ISF and they transitioned to everything being in myClin and that was really good that we had remote access to it.  And because it was the same document just viewed in two different kinds of ways, you know that you have the same version as the site does. So that’s very important. There were a few documents at the sponsor in their central files that had not made it into myClin. So, really there were only two places. There was myClin and there were sponsor’s files, because as the monitor, I knew that what the site had matched what was in myClin. A great way of sort of making it easy on yourself.

Adam Wood: How was your email communication filed and how was it filed to show Oversight by the sponsor?

Lorne Cheeseman: Key emails were filed in myClin as documentation, and that was done on an ongoing basis. As we did the preparing, there were some situations where we didn’t have the emails. For those that had emails, we went through them and ended up just printing them out for expediency. If we had a bit more time, I would’ve put them into myClin as well. But we printed out a few of them just to bring clarity to things. So, Oversight by the sponsor is just sort of by who you’re copying and that sort of thing. Again, though, in a scenario where you’ve got key correspondence that you really need to confirm and document that myClin has that ability to do the “File It” button (acknowledgement) on it. So you could move an email into myClin and then require certain people to file it and then you could document that. We didn’t really have that situation again, small teams, so we didn’t have major concerns.

Adam Wood: The compact nature of your study does lend itself to this approach. And that’s a relief. Can you tell us more about indexing of information? Why is indexing of information so important?

Lorne Cheeseman: Indexing is hugely important. So there’s indexing and there’s also tagging. And both of those things are really important because that’s going to help you retrieve it efficiently at a later date. Also, depending how you set things up, you can use that for Oversight. Another separate situation that I’m working on right now is, we actually have people reviewing things and tagging them accordingly as they do QC checks in the TMF. But, we’ve used the DIA reference model for our TMF. And it helps you to retrieve things and you know where to look for things. And that was part of the efficiency of being able to retrieve things during the actual inspection, because the paper files were organized in the same way.

Adam Wood: I’m aware of a fair number of TMF installations where the TMF is something that’s siloed away from your clinical operations team. Maybe TMF staff manage the TMF, but then what are clinical operations doing? What’s happening with their documentation? What’s your view on that sort of siloing away of a walled garden that nobody can visit?

Lorne Cheeseman: I believe that information should be sort of open and people should be able to access it within reason. First of all, training people on an ongoing basis on how to put information in there, how to tag it, and how to organize it is very important because that’s going to cut down the amount of work. And then people are able to just see the things relevant to them and access it. So as a monitor, I could see pretty much everything and it was really helpful for me to get that perspective. Within a system you want to wall off some stuff, but you want to be careful about that. The challenge is the more you wall stuff off, the more you have to have dedicated people to kind of feed and water it and make sure everything’s good. And that takes up a lot of resources and infrastructure. And if you train everybody how to do it and get more wide access, you can gain some efficiency in two things. One, those people are doing a lot of the work. And then two, they’re aware of what’s there, and are aware of the story as it’s evolving. One of the things, again with myClin, is you get alerts. So as a senior person who’s responsible for Oversight, you’re getting regular alerts and you can see at a high level what’s going on and you can see how the TMF is building.

Adam Wood: It still perplexes me why some people view the TMF as some separate system that needs to be kept away from the people that generate the content and actually execute the study.

Lorne Cheeseman: The other thing is that the sites have access to it and you can make visible the appropriate pieces to the site and that creates their ISF. So like protocols, you file it once and you have that in your TMF and you make it available to all the sites and therefore that’s automatically in the ISF at the same time. And you don’t have to worry about like, “Oh, did we send this version of the protocol to the site yet or not? And did they sign off on it or what?” Because you can track all that.

Adam Wood: What was your approach to missing information? I guess there was stuff from before you became a monitor. So what was your approach to missing information or documents?

Lorne Cheeseman: Well, because we were looking at things for completeness on an ongoing basis, we would try and hunt it down. So yes, there was missing information and some of it we were able to find in a timely fashion before the inspection, because we were looking at an ongoing basis. Now there was some information that was just plain missing and we couldn’t find it. And that’s where we put a note to file it and to explain what had happened and why it was missing or how it became missing or something like that, and putting those on file. And then importantly filing them where that document would be expected so that when we went to look for it, we’d see a note to explain why it wasn’t there.

Adam Wood: Thank you very much! Lorne, great chat once again.

Watch the full webinar at Inspection Perspective: Tales From a Recent FDA Inspection.

By Adam Wood, VP, Business Development at myClin

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