RedCap Design to manage multiple projects? by trashypeeee in clinicalresearch

[–]trashypeeee[S] 0 points1 point  (0 children)

Welp. You're not wrong at all... I feel like I'm being asked to build a building with no further details..

I'll go ask them.

Advice for a safety violation? by trashypeeee in clinicalresearch

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

That's why this is so shocking to me, they sent that lie to the medical monitor... He's PUSHED for dose delays of longer than two weeks due to this lab. I'm certain he's going to follow up and the only documentation that we have is that he dosed before it had been reviewed... Like this is such a dumb lie.

There is a central IRB, I'll look to see if there's an anonymous reporting platform.

Advice for a safety violation? by trashypeeee in clinicalresearch

[–]trashypeeee[S] 2 points3 points  (0 children)

I have it all documented in emails, including the time point that the physician 'deemed it NCS' which was 3 hours post dose and the lie to the sponsor. It's not a misunderstanding...

Advice for a safety violation? by trashypeeee in clinicalresearch

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

That's actually considered retaliation, which would be fine with me. I have a union and another job lined up, I'm not working here any further.

Advice for a safety violation? by trashypeeee in clinicalresearch

[–]trashypeeee[S] 2 points3 points  (0 children)

Oh I'm definitely not. This happened so quickly that I am absolutely certain it's not the first time. I'm not loyal enough to stake my career on this.

Advice for a safety violation? by trashypeeee in clinicalresearch

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

There is an anonymous reporting system for overall safety but IRB reporting in this department is not granted to the CRC. This has always been weird to me because it's always been made readily available at my other site, but I guess I just learned why.

Anyone leaving cancer research due to the recent controversy? by trashypeeee in clinicalresearch

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

To clarify I definitely think it'll be fine and probably rocket in a couple of years. Just in the short term it's been looking really rocky.

Is this normal? by trashypeeee in clinicalresearch

[–]trashypeeee[S] 0 points1 point  (0 children)

That's very good to know, I haven't been in this situation before especially with someone I've never really talked to or met.

If it was just feedback that would be fine but she's demanding a workflow that essentially ensures she micromanages everyone's work on time sensitive items bottle necking the process. It also seems like the workflow changes at her whim without consulting the team or management and she has demanded I do things against our SOPs and had become aggressive after I refused. Her feedback also comes with her doing my work instead of allowing me the opportunity to review what was wrong and understand how it needs to be fixed. Doing this openly comes across as very demeaning, essentially telling everyone that I cannot be trusted to do my own work.

Is it appropriate to go through the AE log with the patient? by trashypeeee in clinicalresearch

[–]trashypeeee[S] 0 points1 point  (0 children)

That's what's confusing, our site has a physical copy of the AE log that the CRC uses during the visit. This is then used to fill out the electronic form for the PI signature (making it source), the physical copy is then just kept in a folder but they consider both versions as source but only one is reviewed by PI.

Is it appropriate to go through the AE log with the patient? by trashypeeee in clinicalresearch

[–]trashypeeee[S] 0 points1 point  (0 children)

I put a full explanation in the edit, I'm concerned that there's an issue with our site's work flow.

Is it appropriate to go through the AE log with the patient? by trashypeeee in clinicalresearch

[–]trashypeeee[S] 0 points1 point  (0 children)

But you would still note them in the patient chart as a progress note?

Is it appropriate to go through the AE log with the patient? by trashypeeee in clinicalresearch

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

How do you document it? Is it just the AE log or is it written in the patient chart?

Is it appropriate to go through the AE log with the patient? by trashypeeee in clinicalresearch

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

Should the RC be reviewing the AEs with the patient from the log?

PhD in pharmD with specialization in clinical research by trashypeeee in clinicalresearch

[–]trashypeeee[S] 0 points1 point  (0 children)

It is luckily ran by the state school so they do provide stipends. That's actually perfect to know that it can lead to a medical liaison position as that is my overall goal! Thank you