Warning Letter: Failure to follow Protocol (ucm 366762)

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Ofni Systems

Protocol [redacted] required that you dispense a handheld electronic device (LogPad) to subjects at Visit 2, prior to surgery, and that the subjects record their pain assessments in the LogPad during the study. You did not dispense a LogPad to Subject 09-006 at Visit 2 on March 4, 2011, because the subject was sedated and on a ventilator. In addition, five pain assessments for Subject 09-006 were entered into the LogPad by the study coordinator, rather than by the subject. During the inspection, your study coordinator indicated that she used the subject’s login code and entered the subject’s pain-assessment scores into the LogPad when the subject was unable to provide a pain score. In your October 3, 2012, written response, you acknowledged that the LogPad was not dispensed to Subject 09-006 prior to surgery. You noted that after surgery, the subject was put on a “vent” (ventilator), was sedated, and was unable to participate in the evaluation of pain, via the LogPad or otherwise….

…By failing to ensure that pain-assessment data were entered only by the subjects, as required by the protocol, you compromised the validity and integrity of data collected at your site. Protocol [redacted] required that the subjects record their pain assessments in the LogPad during the study. For Subject 09-006, the LogPad contained assessments purportedly made and entered by the subject; however, five pain assessments were entered by the study coordinator and reflect the study coordinator’s or nursing staff’s assessments, rather than the subject’s assessments.

View the original warning letter.


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