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Digital Signatures in Clinical Trials (Electronic Signatures)

Clinical Data ManagementGood Clinical Practice

Digital Signatures in Clinical Trials (Electronic Signatures)

A digital signature, also referred to as an electronic signature has been developed using the cryptographic techniques of verifying the originator. Using this technique, the identity of the person who uses a digital signature can be verified. The electronic system uses a complex set of rules and parameters to achieve this.

A digital signature is also known as an e-signature these days. It can be any electronic medium which certifies that the person who has signed the document electronically has read and understood the contents of the documents and is willing to comply with them. In simpler terms, it can be said that an electronic signature can be a synonym to a seal and will be considered legal and verified as the traditional hand written signature.

So how does the clinical research industry benefit from this? As we are aware that most CROs across the world are going paperless, digital signatures and record keeping is becoming more and more adoptable. It would not be fair to not include other players in a clinical research ecosystem like IRBs/IECs, sponsors, site personnel and investigators who could and are benefiting from this concept. Expenses and time constraints are constantly at a rise for sponsors and CROs. They need to keep coming with innovative methods to curb both. This is the reason why corporates are adapting to methods like digital signatures and electronic record keeping in clinical trials to execute the process of research electronically both at site and corporate levels. Digital signatures enable all key players in clinical research to submit their documents electronically. This is turn enables efficient regulatory compliance by saving significant amount of time plus saves up a lot of costs as well.

Other advantages of digital signatures in trials are that it provides concrete and compliant proof of the signer’s identity and hence provides document integrity as well for anyone who receives the document. This enables to leave a concrete audit trial that allows the reconstructions of events relating to the creation, modification and deletion of the document. Sometimes it is easy to manipulate and encourage malpractices with traditional hand written signatures, but with digital signatures, this is rather impossible. To know more about compliance with digital signatures and records with regulatory authorities, please visit the website www.fda.gov and refer to 21 CFR Part 11 to know more.

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