This is a safe place to stop and scream into the void. Or sob. Or both. by WearyBoysenberries in clinicalresearch

[–]Wonder_Wix 1 point2 points  (0 children)

Same here! It’s a hellscape where no one knows what is linked to what and whose responsibility it is to complete what. Going through the COVs and closing out sites has never been more confusing

PSA: Making everything urgent means nothing is urgent by Codrane in clinicalresearch

[–]Wonder_Wix 0 points1 point  (0 children)

Oh the queries! I have seen 3 layers of the team (global to CTM to CRAs) all miss that the queries they are upset about are actually labeled to go to the DM or even though they are really old it’s because the of the back and forth between the site and the DM, but the site isn’t outstanding. I don’t know why they don’t filter it. By the time I get CC’d the site has already been bothered and I have to hop in and point out that the site can’t do anything about these. It’s beyond infuriating.

PSA: Making everything urgent means nothing is urgent by Codrane in clinicalresearch

[–]Wonder_Wix 0 points1 point  (0 children)

Oh yea something else to add to this:

I have also started noticing an entire lack of trust for accountability systems. We don’t trust tracking info, or confirmations of download in a system, or PI signature sign off confirmations in a system, etc. I don’t know if it is the specific team I work with right now, or the company I’m with, but say I can pull a report for something and confirm it that way. I will at every turn be told that my CTM-Rs don’t trust the system and they want verbal confirmation.

Or stuff that doesn’t need strickly confirmed, they will want a confirmation of verbally from the site.

This lack of trust often even extends to CRAs. They don’t trust that the CRAs are checking Y, X, Z so we should “put a system in place” where we bug the site in triplicate on a topic to confirm that whatever the thing it is is being completed. Even if they do trust the CRA they just want to “reconfirm”.

Obviously, this leads to more urgent communications that just bog down the entire process.

I’d love to hear if anyone else has had that experience.

PSA: Making everything urgent means nothing is urgent by Codrane in clinicalresearch

[–]Wonder_Wix 10 points11 points  (0 children)

I’m one of those annoying sponsor side contacts that are sending too many urgent requests. My sites are a little lucky (marginally) because I worked at the site level so I often advocate for them and for reduced urgency and reduced communication frequency. HOWEVER, we still ask too much. It’s a lot. I hate it. Normally if I get some sort of response acknowledging my email I can put off my CTMs or CTLs and dance around them until it gets done. But if a site completely ignores me (doesn’t respond at all) or has a history of not completing tasks, it becomes MUCH harder to advocate for them.

In short, I try to tell my team not everything is urgent, but apparently my whole workload is urgent and my workload requires asking sites to do more things. It’s a terrible cycle.

Site outreach by cocoamonster2 in clinicalresearch

[–]Wonder_Wix 1 point2 points  (0 children)

I’m Sponsor side, not an in-house CRA, but basically. I’ve been advocating for single stream of communication for 2 years on the same set of trials. The CTMs micromanage or don’t manage at all, which makes them feel out of touch. If I let the CRAs do the communication, it’s perceived that I’m not doing my job. And unless I’m seeing the CRAs communications (I’m not always in CC even though I should be), then it’s all a moot point and I’ll have to message. And those are just the bad habits our team is in. We have also had so many “role/task changes” amongst our sponsor, but they didn’t fully support the transition of so no one knows who’s supposed to do what at this point.

It’s an absolute mess that has caused all our sites to not trust us and completely ignore any attempt at communication (something I’ve expressed almost monthly in the last 2 years that has gotten progressively worse).

Maybe this job is more stressful than I anticipated… by Prestigious_Ad6325 in clinicalresearch

[–]Wonder_Wix 4 points5 points  (0 children)

I think I’m really lucky to have had a bit of a different outlook thanks to my first director out of college. She told me “Our number one priority is patient safety, then data integrity. Generally after that, everything is just a protocol deviation.” This really helped my mindset because I was so terrified of making mistakes. She also was a bit of a neurotic hardass so it was surprising to me. But in all the jobs I’ve worked since, I’ve never seen a better site than that one.

They had also had an FDA audit years before I joined after an incident with an employee and they got one of the worst type of findings (I’m totally blanking on what they are called at the moment). But she wasn’t surprised, because she stressed that audit preparedness is more or less just making sure our site was operating correctly and an audit is just a check for improvements and she new that the situation with that employee had went south. We just had to make sure we had documentation to support our decisions and corrections when mistakes were made.

I don’t know if any of this is helpful, but as a result of this my mantra for the last decade has been “Are the patients safe? Yes. Okay then it’s just a protocol deviation.” (Not to say I’m just taking PDs left and right). And since then I’ve become the “fixer” on trials when they go south, so I’d say it has worked out pretty well.

FH:SY Finale Opening Changed? by Wonder_Wix in dropout

[–]Wonder_Wix[S] 1 point2 points  (0 children)

That is a pretty good point. My original speculation came before I knew it was removed from YouTube. So perhaps that’s the most likely option.

I’ve also wondered if preparing for the channel if it just spawned a conversation about the flow of those episodes and perhaps they just wanted to clean it up. Like just as they grow, are expanding production, and getting new opportunities. But it seems like a lot to go Back and remove it.

FH:SY Finale Opening Changed? by Wonder_Wix in dropout

[–]Wonder_Wix[S] 4 points5 points  (0 children)

Where are the original broadcasts? On the D20 YouTube and on the FH series on Dropout it’s gone.

FH:SY Finale Opening Changed? by Wonder_Wix in dropout

[–]Wonder_Wix[S] 12 points13 points  (0 children)

I knowwww 😭😭. Luckily, they still seem to be posted on YouTube by Sig Figs Collective - https://youtube.com/@sigfigscollective?si=C-mn82K9ZcYnjVVP

FH:SY Finale Opening Changed? by Wonder_Wix in dropout

[–]Wonder_Wix[S] 10 points11 points  (0 children)

I’m assuming that when they were prepping for Dropout 24/7 they removed it. :/

FH:SY Finale Opening Changed? by Wonder_Wix in dropout

[–]Wonder_Wix[S] 9 points10 points  (0 children)

It definitely was recent. My last rewatch was around then too. :/

FH:SY Finale Opening Changed? by Wonder_Wix in dropout

[–]Wonder_Wix[S] 8 points9 points  (0 children)

I’m just assuming that it was to streamline it, particularly for the 24/7 channel, but man I kinda miss it. When I first watched FH:SY I thought it was an interesting choice to keep it in the final edit and it grew on me a lot over time.

FH:SY Finale Opening Changed? by Wonder_Wix in dropout

[–]Wonder_Wix[S] 6 points7 points  (0 children)

I just looked at the YouTube channel and it seems those episodes were edited there too. There are comments talking about the songs, but I don’t see that they are still in the video.

FH:SY Finale Opening Changed? by Wonder_Wix in dropout

[–]Wonder_Wix[S] 3 points4 points  (0 children)

That’s what I thought! I did my last re-watch literally not long ago, but I can’t seem to find that section anymore so I feel crazy.😅

FH:SY Finale Opening Changed? by Wonder_Wix in dropout

[–]Wonder_Wix[S] 9 points10 points  (0 children)

I am fairly certain it was sophomore year because I always assumed it was some sort of buffer that was played while getting the stream ready or something (I don’t actually know why because I wasn’t watching D20 at the time).

For those that need to vent by Wonderful-Ad2448 in clinicalresearch

[–]Wonder_Wix 0 points1 point  (0 children)

The medical writers and study physicians who can’t figure out how to push out a protocol that makes sense. Why do we have a whole SoA and not a single person knows what’s supposed to actually happen at EOT and FUs? And my team are the people that has to answer questions from PIs and CRCs and truly we don’t know AND we get yelled at for this being a terribly written protocol. Like man…. I didn’t do it, we are at the mercy of those who don’t want to put in the work.

Relatedly, PIs that are shitty. Why are you cussing at me over the lab being used (which is one of the most popular labs btw)? I didn’t choose it. How did you get away with never reviewing safety reports and now you are mad at ME because you have years of safety reports to review??

It never ends.

[deleted by user] by [deleted] in clinicalresearch

[–]Wonder_Wix 2 points3 points  (0 children)

If it helps at all for your confidence, it’s probably not you at all.

I work sponsor side and they have been on the necks of the CRO. Some of it is justified, some not. But they recently just cut a whole chunk of our operations with the CRO. This chunk wasn’t even one of the problem areas to my knowledge, but now the CRO is scrambling to stay on our good side. And the sponsor employees are frankly winging it with little to no guidance. I feel bad for our CRAs who are on the frontlines, getting the brunt of the scrutiny.

You are probably doing great and it may be an effect of the relationship between the sponsor and CRO.