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Disclosure obligations for clinical trial participants typically come from the trial protocol and informed consent

Needless to say, the surveyor noted the lack of documentation about medication errors as a deficit in the survey and indicated that she did not believe that they only had three medication errors in the past year

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More specifically, they noted that at least one subject's Central corneal endothelial cells (CEC) density measurement was not completed before enrollment, which was one of the enrollment criteria, and another enrolled subject had Intraocular pressure (IOP) that was outside the criteria