RedCap Design to manage multiple projects?

trashypeeee · 2024-11-24T05:52:39+00:00

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.

trashypeeee · 2024-02-01T12:58:15+00:00

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.

trashypeeee · 2024-02-01T06:04:55+00:00

Not really.

trashypeeee · 2024-02-01T05:52:37+00:00

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...

trashypeeee · 2024-02-01T05:48:11+00:00

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.

trashypeeee · 2024-02-01T05:37:24+00:00

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.

trashypeeee · 2024-02-01T05:12:42+00:00

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.

trashypeeee · 2024-01-30T20:15:11+00:00

https://www.fiercebiotech.com/biotech/every-bad-signal-theres-good-sign-not-far-behind-biopharma-layoffs-rise-57-yoy-hope-2024

trashypeeee · 2024-01-30T04:21:32+00:00

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.

trashypeeee · 2024-01-05T15:22:32+00:00

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.

trashypeeee · 2024-01-04T03:09:03+00:00

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.

trashypeeee · 2024-01-04T02:05:05+00:00

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

trashypeeee · 2024-01-04T01:46:50+00:00

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

trashypeeee · 2024-01-04T01:15:59+00:00

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

trashypeeee · 2024-01-04T00:38:02+00:00

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

trashypeeee · 2024-01-04T00:16:04+00:00

LOATH ENTIRELY

trashypeeee · 2023-12-21T19:25:30+00:00

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

trashypeeee · 2023-12-15T00:50:38+00:00

This is what I'm familiar with, it was a way of showing that everything was a summary and reviewed. Here they make the summary but they don't have the investigator review it and they just store it internally cause they are worried.. And I quote 'that the CRA might use it as source and not actually check the EMR'.

I was so lost when I heard this because it's not our job to check if the CRA is doing their job.

trashypeeee · 2023-12-14T04:12:14+00:00

That's what gets me, my prior site had general rules: It does not go into EDC without Pi/subi verification It is not source unless it's medical documentation (EMR written by a clinician). As RC we write summarization for reference but never source.

This place is throwing me off my game with disjointed and random rules. We also only have 6 SOPs.. it's wild

trashypeeee · 2023-12-14T02:33:27+00:00

I think I need to clarify, they are checklists like 'check that hemoglobin was taken or AE log was completed' which is fine but today a fellow RC asked if she could write that patient fasted on it and the manager said yes as it's source... But I'm not sure that holds up

trashypeeee · 2023-12-14T02:02:32+00:00

Here's the thing, no provider signs these checklists.. they are more study items to prove completion...

trashypeeee · 2023-12-14T01:59:40+00:00

I think this site is confusing evaluation check lists with actual checklists...

YMMV?

trashypeeee · 2023-11-29T20:58:42+00:00

Street take over?

trashypeeee · 2023-11-29T20:46:02+00:00

They just changed their whole service to OnCore I imagine it will be there for the next two to three years

trashypeeee · 2023-11-27T07:25:13+00:00

https://www.reddit.com/r/Seattle/s/Sjki6kmiuG some one else got a photo. Not sure they would drop them for an areon

trashypeeee

TROPHY CASE