When site personnel complete subjects’ e-diaries, bad things happen. Don’t let them happen to your company! A recent FDA Warning Letter questions the validity and integrity of ePRO data captured at a clinical investigator site. What’s a sponsor to do to avoid the same fate? How to Protect Your ePRO Data 1. Select an ePRO… [Read More…]
Does scanning always result in true copies?
Unfortunately, the answer is no. Yesterday, NBC News reported that Xerox scanners using a compression algorithm called JBIG2 were changing characters during the scanning process. That’s right! 6s randomly become 8s! No worries, you don’t scan anything and hope the scanned version is an exact copy of the original, do you? Of course you do…. [Read More…]
