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> Unless you have some way to also blame the management responsible for deciding such a design should be implemented.

Their name is on it as well, with text describing what they approved.




Well, that makes it a lot better then. Nice to know this issue was considered in some form.


This happens to various degrees in the clinical research industry, depending upon the nature of the work (partly thanks to 21 CFR Part 11!). Several years ago I worked in data management on a maintenance team for clinical trial databases.

Company-wide, there was a rigid system in place that captured electronic signatures as change requests were documented, code was modified, and tests were completed.

Anything that was done flowed through at least those three distinct groups (data team lead, maintenance programmer, & QA). We could easily tell how a study's database had been modified in the past (including who had requested the change, who programmed the change, and who tested the change)...there was always an expectation that every i was dotted, t was crossed (or semicolon was in place) before anyone signed off on their work since it would permanently enter the record and couldn't be erased.




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