Getting An AE after dosing then failing a urine screen

[cantgetright]

Got dosed in a study with multiple in house stays and multiple dosing periods. Got dosed in period one. Noticed the AE during the washout and returned to clinic for admission in period 2 to report the AE. Being familiar with the check in a process at this unnamed clinic I was waiting for the staff to ask me about any changes in my health in their AE assessment for the inclusion/exclusion.

I had to check-in a couple of days earlier because of a blizzard so the AE assessment was wasn't done first. They took a urine sample first and it was positive for ine. There are a few ways one can test positive for ine but nonetheless, this was unexpected and it was discovered prior to me reporting the AE. I eventually reported the AE but the positive test was more of a concern than my AE. I showed the staff physical evidence of my AE and they told me to go to Emergency Room.

I was admitted to the er for soing that developed after I dosed in the study, so I would've been excluded anyway without the positive test because I was prescribed medication by the e.r. The clinic still may've tried to screw me without the positive test but they'll definitely try to blow off my AE altogether now. Not sure if there's a chance I could get compensated for the rest of the study but I'll look into it.

[vark]

if they dont offer to pay your full study pay, lawyer up, with the kind of plaintiff's lawyer that handles car accidents.
they will seek money for you. they will refuse to tell you how much to expect, but i've heard fourthhand, just as a rumor, that 3 times medical bills is typical. not for studies specifically, just cases in general where there's any medical expenses. also see if at the emergency room they ran any labs and if so did they test for ine. if not, go spend $25 or so for a lab test to see if you have ine in your system. because if you dont, you might have just walked by a guy with a cigar, or got a false positive, but if you do, that suggests you've been smoking or otherwise exposed to smoke. just in case that becomes relevant somehow. i got banned for a year in wva once for ine, and i've never smoked and avoid smoke. the tests can be supersensitive and can be prone to false positives.

[cantgetright]

Thanks for the reply Vark. I asked the staff at the clinic if they could do labwork on me when I got there but they said they couldn't until 2 days later and told me that the ER would but that didn't happen. I've been at this unnamed clinic since Friday waiting to be evaluated.


I'm awaiting end of study procedure's. Haven't seen the doc yet because they haven't showed up to the clinic yet because of the blizzard of 2016. I contacted the IRB that approved the study to see if they could provide some insight about my situation. They only had one person available and they told me that I could only be compensated for the time I spent in-house for the 2nd period, not for the full compensation of the study so they don't seem like they'll be any help.

I've never had an issue like this before so I'm not familiar with how IRB's operate. Do you know if I could contact another IRB about this or do I have to use to the one who approved the study?

[cantgetright]

I finally saw a doc at the unnamed clinic, and underwent a physical and all end of study procedure's. This clinic used to pay you the full compensation if u had an AE that took u out of the study but they're saying they'll only pay me for the final visit. They're downplaying my AE and basically saying that the positive urine overrides the fact that their drug was in my system prior to that.

My AE was swelling, pain and pus leaking from my left shin that caused me to be admitted in the ER. These sides effects weren't listed in the consent form, but I researched them myself and found out that swelling of the lower legs was a common side effect of the study drug (redacted by a moderator). Also they had me repeat blood for screening due to a high CRP level which is caused by a sing of inflammation in the body. I was told my levels were still outta range after the repeat and I couldn't dose, but then they changed their minds because they were short people and needed to fill the study.So technically they weren't supposed to dose me anyway.

The doc and their staff tried to act as if the study drug had nothing to do with anything and the side effects I experienced were common in taking the drug but conviently left outta the ICF. Doctors are drug dealers and worse than the nickel and dime ones people look down on.

Not sure how and if I can seek full compensation from this clinic

[vark]

you can only use that one irb. it sounds offhand like they are useless but give them soing in writing.
also contact the sponsor. they might make it right.
also ask the clinic for a written letter about their refusal to pay. then, as i said, lawyer up if you want to get paid.
how much do you value your relationship with the clinic? if you insist on getting paid a fair amount they might put you on a do not recruit list.
your call.

[cantgetright]

The clinic will definitely ban me. For life more than likely so I guess it wouldn't hurt to contact the sponsor and IRB. All clinics and jobs have their pros and cons but The clinic isn't bad overall.

[vark]

if you are trying not to get banned, don't contact the irb and the sponsor. it would be unethical for them to ban a person for pursuing their legal rights, but as far as i know it's legal, and the ethics go unenforced most of the time. it's one of those catch 22's. it usually makes sense to lawyer up only when you've already been banned or there's a large amount of money potentially at issue that would offset the lost income. i do suggest you get a free consultation with a lawyer somewhere who can give you real advice, but you will most likely conclude to suck it up and keep doing their studies.
Ok, i see that you have already contacted the irb and they weren't helpful. that's not atypical. I'm unsure if you are saying you've already been banned, in which case go get a lawyer, but if you haven't been, you'll have to make a decision.
My guess is that after the recent brain-death of a french subject, the clinic would rather not see its name in the paper.
I think you've done the right thing by not naming the clinic here. Assume your clinic reads this board and nothing you say here is private or confidential.