21 Code of Federal Regulations Part 11-Compliant Digital Signature Solution for Cancer Clinical Trials: A Single-Institution Feasibility Study.
Therica M MillerJenny LesterLorna KwanMegha D TandelBeth Y KarlanBobbie J RimelPublished in: JCO clinical cancer informatics (2021)
The use of digital signatures resulted in a decrease in document completion time and regulatory burden as represented by staff hours. Additional cost and time savings and information liquidity could be realized by integrating digital signatures and electronic document management systems.