Quote from brad on July 15, 2022, 2:19 pm
Here's a bit of a wrap up from the 3 day audit.
Ultimately, in the opinion of the auditor, nothing rose to the level of 483 but this was a very messy and chaotic study. We definitely learned we need to stop, take a breath, and think about any changes in documentation that we make - especially those that are at the direction of a CRA. We did have some newer CRCs working on this particular study so it's difficult to know when to challenge and CRA and it takes a certain level of confidence to do that. That takes time and experience. I, personally, should have been more diligent in helping support my CRCs throughout such a difficult trial (easier said than done.)
Ultimately, it is clearly important we take more specific and concise progress notes so every change that is made can be easily tied back to something. We had too many instances in which we changed something that was right the first time but didn't note why we changed it and then it was difficult to determine after the fact.
We had a couple of very "messy" patients who were implanted and then unable to randomize and then needed revisions which created a lot of confusion in terms of visit windows and the timing of visits so we learned we needed to do a better job of accurately and concisely documenting the chain of events as they happened.
All in all, the moral of the story is we strive to ensure each binder could be reviewed by a third-party and they could make sense of the complete patient journey without having to ask questions. Each binder should be closed loop, so to speak. It was actually a great experience and the lessons we learned were very valuable.
I'll eventually write a more coherent article about this so sorry for the stream of consciousness for anyone who was kind enough to read along.
Here's a bit of a wrap up from the 3 day audit.
Ultimately, in the opinion of the auditor, nothing rose to the level of 483 but this was a very messy and chaotic study. We definitely learned we need to stop, take a breath, and think about any changes in documentation that we make - especially those that are at the direction of a CRA. We did have some newer CRCs working on this particular study so it's difficult to know when to challenge and CRA and it takes a certain level of confidence to do that. That takes time and experience. I, personally, should have been more diligent in helping support my CRCs throughout such a difficult trial (easier said than done.)
Ultimately, it is clearly important we take more specific and concise progress notes so every change that is made can be easily tied back to something. We had too many instances in which we changed something that was right the first time but didn't note why we changed it and then it was difficult to determine after the fact.
We had a couple of very "messy" patients who were implanted and then unable to randomize and then needed revisions which created a lot of confusion in terms of visit windows and the timing of visits so we learned we needed to do a better job of accurately and concisely documenting the chain of events as they happened.
All in all, the moral of the story is we strive to ensure each binder could be reviewed by a third-party and they could make sense of the complete patient journey without having to ask questions. Each binder should be closed loop, so to speak. It was actually a great experience and the lessons we learned were very valuable.
I'll eventually write a more coherent article about this so sorry for the stream of consciousness for anyone who was kind enough to read along.
Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"
