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Insight makes it easy to ask questions of ALL of your clinical and operational data and visualize answers via interactive reports and dashboards. The idea is simple, but the results are powerful: ask your questions, choose your visualizations, then return often for updated, interactive results that link you to all of the underlying data.

electronic signatures

I'm curious about something regarding electronic signatures and OpenClinica.. When I read the part 11 document I thought I needed to record the actual signing and include certain data points (we have had different QA consultants expect different things in this regards so maybe its not a standard practice).. anyway I'll paste the part 11 doc I'm referring to below.. b ut basically when I see that I read that I need to record the name, datetime, and meaning.. I don't see this anywhere in OC.. am I missing it????



Subpart B--Electronic Records

Sec. 11.50 Signature manifestations.
(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:

(1) The printed name of the signer;

(2) The date and time when the signature was executed; and

(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).
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