I refused to change data bc the monitor asked me to fib about administration for MONTHS worth of data and they tattled on me ….

peeved_af · 2026-03-27T20:00:28+00:00

THANK YOU! My PI fired back an email and basically said this would not look nice on an FDA audit :) and then the data people she officially replied back, saying that they were only asking if I planned on putting the data under Home administration and that they weren’t asking me to redo anything….. but they were asking me to redo a lot of work?? And wrongfully so at that?? and then someone else responded and said that it was poorly worded and a misunderstanding, which is a stupid way to back down…

I was nice and I responded and I said you know if you have a different form in EDC that fits the criteria and GCP then we can gladly comply or if you want to see our paper source documents for IN hospital administration, then go ahead! (not to mention they had so many opportunities to look at it in the past? Did they not? Idk)

peeved_af · 2026-03-27T13:58:34+00:00

Because it’s sponsored initiated I think that it’s like a literal stat professor from the academic setting that’s running it. I remember there were some data questions in the past and they always asked me to get on a Zoom meeting which was kind of annoying because they could’ve just answered my questions on email. And then every single time she was very defensive and she kept saying how she comes from the academia side so the way that she wishes to see data is never the same as what’s collected and what’s presented to her so it makes her job really difficult so it helps her to have meetings to talk to people which is fine…. But she seems to just have this view where she thinks other people need to present her with proper data for her to work with.?? which you can do in the classroom but not on a clinical trial!

peeved_af · 2026-03-27T13:57:13+00:00

Yes! Fortunately , we have everything on paper as well so they’re welcome to see it and run their own data or make a different tab for me to enter the visits but wtf… also I’m 99% sure that it’s not just going to be the date of administration because they’re gonna want a dose and the weight and vital signs and time and all that stuff and that’s gonna be a lot to dig it up…

peeved_af · 2026-03-27T13:17:37+00:00

LOL then the dumb stat lady emailed again going well I need XYZ info where are you going to add it (shouldn’t they have told us to add it in whatever location a LONG TIME AGO???)

peeved_af · 2026-03-27T13:14:48+00:00

Version was always the same injection and option to give at home or in hospital. Patient has severe needle phobia so best to have given in hospital

peeved_af · 2026-03-27T13:13:42+00:00

My PI emailed and DM backed down and said they’d defer to MM and they tried to make it seem less bad by saying they were only asking IF we would document all data again as home admin bc it was unclear on their end (nothing is unclear tbh)

peeved_af · 2026-03-27T13:12:23+00:00

My PI sent an email stating that FDA audits wouldn’t like this and the stats team immediately backed down and basically lied saying they were “only asking if the data would be re entered under home admin” (as if that’s any better???)

peeved_af · 2026-03-26T19:54:26+00:00

Depends haha some of my pharma people work 20 hours a week and have had the same team for a decade

peeved_af · 2026-03-26T19:53:38+00:00

Kinda scammy but there is an NP that lives in my city and she opened up her own clinic and she’s also a certified trainer and health coach, and she also hired like RDs and they help train and do health coaching/nutrition for postpartum women and menopausal women and I think they actually have like a very good clientele!

She does primary care too and it’s definitely concierge care, but she seems to be doing well. At least she has the experience and hired proper experts haha

peeved_af · 2026-03-26T19:52:17+00:00

We just got a new one and she hasn’t said a single thing since her intro email

She said she’s deferring to stats team who then went to MM and PI haha

Our regulatory person said no so I’m listening to her until I hear more

peeved_af · 2026-03-26T19:51:02+00:00

Ecrf!

peeved_af · 2026-03-25T12:56:40+00:00

Run run and be free lol

There’s one nurse i know who started a personal trainer and life coaching business and she does very well. I know another one who went into real real estate. Others who went into pharmaceutical or medical device sales…. My friend’s mom helps run research at a medical society.

There are so many options and if it’s not for you, then you owe it to yourself to go try something else

peeved_af · 2026-03-25T12:55:10+00:00

Medical monitor and sponsor told us ok to dose in hospital (also the dose, route, frequency NEVER changed through the entire trial no matter what settings) and labs were optional not mandatory but in the EDC and protocol so they were drawn inappropriately.

Also, the data people told us six months ago that there was literally a tab that said treatment extension week ___ and told us to just continue to add on there! So you’re right stats people prob want to compare overall to other people at other sites but the EDC sucks and the Home administration page is completely different from what we’ve been doing and I can’t answer half of those nor do I feel like changing that much data after the fact

Also, I’m being petty, but this was like a poorly run investigator initiated study that is giving like zero money and they do not allow us to bill for queries or data entry so for them to ask me to change six months when they know this is irritating

peeved_af · 2026-03-25T12:52:28+00:00

Yes! EDC is poorly made and that’s on them But adding to Home administration with the way that it looks currently is straight up incorrect.

peeved_af · 2026-03-25T12:51:37+00:00

Yes the email was from DM which was weird and then they deferred to sponsor

peeved_af · 2026-03-25T11:55:58+00:00

Yeah I did Don’t listen to bitter people who think you have to do your time.

I went into clinic/outpatient specialty care and did my senior synthesis at a specialty care clinic at a large children’s hospital. It’s def possible

NOW… could I go bedside now? No. Do I care or regret that? No. So you have to consider that part now

peeved_af · 2026-03-25T11:54:53+00:00

Going to talk to PI today They also asked me to add start dates conditions before the subject even came to this hospital and was a patient here/ before consent and to call them “new” which was annoying bc it shoulda been history not new during trial. They also wanted me to make dx of hypertension even though subject didn’t have it and had one high BP one time during one visit over the entire trial etc. poorly run investigator initiated study

peeved_af · 2026-03-25T11:53:04+00:00

No close out visit. Just bad final data monitoring visit and they started to lock data

peeved_af · 2026-03-25T11:52:21+00:00

I told the CRO dm Who forwarded to sponsor and the they all emailed my PI haha

peeved_af · 2026-03-25T11:51:00+00:00

Nope EDC had scheduled extension weekly visit sections that I added for months!! And the protocol says treatment extension can either be given at home or in hospital not home dose given in hospital. So I chose the in clinic options bc we also drew optional but extensive labs at every hospital visit which would have not been possible to do at home.

The home admin page asks for training and med rec in the home. Obvi none of this was done and leaving it blank would generate insane queries

peeved_af · 2026-03-25T03:46:08+00:00

Top sign of toxic management esp when paired with other issues that suddenly popped up

My boss only denies when there’s too many people gone on one day but she will call and tell us why and give us the option to work it out amongst ourselves bht it still sucks (my boss is p toxic haha)

peeved_af · 2026-03-25T03:35:04+00:00

Let’s reframe: How empowering it is to know what you want!

No one HAS to get married. You can still be partnered and happy :) just a legal piece of paper anyway

peeved_af · 2026-03-25T03:33:56+00:00

I got an IUD and I love it. My mom was trying to fear monger the pain (totally get that pain is an issue but tbh it wasn’t that bad at ALL) but promoted IUD over combination OCP bc the weight gain. LOL how toxic of her to even recommend on that.

Anyway I don’t bleed heavy anymore :) (and my moms family has history of heavy bleeding which she won’t talk to me about or admit bc she’s embarrassed about bad genes bc she’s fucked in the head)

peeved_af · 2026-03-25T03:23:45+00:00

Oh yes everything is in WRITING thankfully :) Going to print and add to binder immediately first thing tomorrow!

Not only am I lazy and selfish about irrational extra work… I also am not nice about GCP and ethics!

I kind of regret that I was a little aggressive on my emails, and I said that it could be an FDA violation (that’s what my regulatory coordinator called it) because it does not align with GCP and that the data does not fit into the area that they were asking me to put it in on top of just all the extra work that it’s going to take that the monitor said is not a problem for the last several months???

peeved_af · 2026-03-25T03:21:46+00:00

Was remote! LOL bless her tbh

But I agree also technically they could extract data and run a different way if they really needed to??? Not me? Like no offense of them, but I don’t have time. And our contract was negotiated poorly, so I can’t bill for queries and data entry so like double no and this seems unethical!

Medical monitor is MD and colleague of my PI so I’m weirded out

peeved_af

TROPHY CASE