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Post by cancobaye on Oct 23, 2019 18:22:16 GMT -5
Hi, anybody have experience if the clinic ask to re sign the consent agreement because they found another side effect (epilepsy).
The study that we are in have 4 period and we are at the moment on the third period.
Tks for your feedback
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Post by labrat1 on Jun 20, 2021 5:45:52 GMT -5
This is a late reply but I personally have not, to my memory, ever had to re-do a consent form in the middle of the study because a new AE had been discovered about the study drug.
That is an interesting outcome, and it seems that any kind of ethics-review boards or IRBs should be on top of it and working on policies so that the volunteer is given more information. But I guess it probably is not all that unusual as far as what a lot of researchers and pharma companies and CROs see and deal with considering that they deal with thousands of studies per year.
I recently had to re-do a consent form because the compensation was increased and I had to sign a new consent form that states the new compensation.
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