gigi
New Member
Posts: 4
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Appeal
Apr 3, 2015 12:38:46 GMT -5
Post by gigi on Apr 3, 2015 12:38:46 GMT -5
Has anyone been banned from a study? What is the appeal process? Is there a mediation?
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Appeal
Apr 3, 2015 12:45:35 GMT -5
Post by vark on Apr 3, 2015 12:45:35 GMT -5
lots of us have been banned from one clinic or another. just getting banned from one study theres not much you can do about. there's usually no formal appeal process no mediation. you can write a letter to the director of recruiting. you can file a complaint with the irb. beyond that, you can ***** to the sponsor or the fda but it probably wont do much good.
why do you ask? are there more details you want to share? edit: oh celerion. dont know, never had that problem there.
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gigi
New Member
Posts: 4
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Appeal
Apr 3, 2015 14:03:45 GMT -5
Post by gigi on Apr 3, 2015 14:03:45 GMT -5
I rec'd a letter of permanent suspension. I made several calls to the study director, leaving numerous messages with his secretary, but no one returned my calls. I wrote a letter of appeal and was told it would be reviewed the following month as the committee had just met the day before. I rec'd a second letter a week later saying they were sticking with the suspension. What happened to the review committee mtg? Still without an answer to why I was suspended, I called the person who signed the letter. She said she had heard it was because of my manipulating adverse affects to my benefit and that I had threatened to leave. Both of these are totally inaccurate. I reported my AE and also reported when it was over. A nurse had left it instead of closing it. I saw the study doctor who said I was fine and she would close it out. How can I defend myself without being heard? Wondering what my rights are, if any, and what my next steps should be. Unfortunately, I now understand why so many AE's go unreported.
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mike
Moderator
Posts: 334
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Appeal
Apr 3, 2015 22:50:28 GMT -5
Post by mike on Apr 3, 2015 22:50:28 GMT -5
What clinic is this?
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gigi
New Member
Posts: 4
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Appeal
Apr 4, 2015 11:47:31 GMT -5
Post by gigi on Apr 4, 2015 11:47:31 GMT -5
Celerion, Tempe
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mike
Moderator
Posts: 334
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Appeal
Apr 4, 2015 14:29:38 GMT -5
Post by mike on Apr 4, 2015 14:29:38 GMT -5
Yeah you can try complaining to the IRB. This clinic has a very strong and organized facebook presence, if I were you I would try hitting them where it hurts, blast them on FB where a whole lot of potential participants will see it, after trying reasonable approaches first, of course.
It's strange that they would misconstrue what happened with your AE's so much, did you piss someone off? Is there someone in particular who may have been the source of the problem?
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