Electronic signatures, eSignatures, are continuing to gain momentum replacing wet signatures in Clinical Trials.
Wet signatures are signatures made by hand on a document, typically with a pen and paper, which are often later electronically scanned into a storage system or maintained on paper and stored in a binder room.
Electronic Signatures, often called eSignatures, are completed digitally by signing a document virtually with no contact with the physical paper. In Clinical Trials, eSignatures must be conducted in a system compliant with FDA 21 CRF Part 11 regulations.
In times of crisis, like during the COVID-19 outbreak, enabling compliant Electronic Signatures can make significant impact on the ability to continue typical operational practices of running a clinical trial.
The immediate benefits of eSignatures are clear – your team can eliminate the printing of most regulatory documents, chasing signers, and scanning and faxing files.
The benefits during a crisis become paramount as utilizing eSignatures allows research teams to drastically reduce exposure to the contagious virus, work remotely without delay, continue trial progression, and protect themselves and patients by safely practicing “social distancing.”
Regulatory bodies, such as the MHRA and FDA, are expecting a spike in protocol deviations due to missed signatures and missing appointments by subjects refraining from entering high-risk areas like hospitals and health systems.
Applying eSignatures can greatly increase workflow efficiency and create a conducive environment to perform work regarding clinical trial management from any remote location.
Recent advances in purpose-built solutions employ eSignatures for far more than these basic benefits. Solutions in eRegulatory and eSource help Research Centers launch management tools like complete audit trails, task management, alerts, notifications, and file management all based around eSignatures.
Florence eBinders has the largest network of sites using eSignatures compliantly for Clinical Trial Management.
The number one question we get when introducing clinical trials sites to Florence eBinders is about eSignature FDA CFR 21 Part 11 compliance.
The FDA, research sites and sponsors that we work with all fully accept eSignatures and are enacting measures to use them more fully during the COVID-19 outbreak.
These ten tips will help you get the most out of eSignatures while ensuring you remain FDA CFR 21 Part 11 Compliant.
Essential FDA Title 21 Part 11 eSignature Requirements
Your organization must have a Letter of Non-Repudiation Agreement on file with the FDA. (Learn More)
Every individual must have two unique identifiers, including a username and password.
The organization must prove the identity of everyone given the ability to electronically sign documents.
A password must be entered every time a document is signed. ie: the signature cannot be saved or auto-populate. Documents may not be signed in bulk.
Information other than the signature can be auto-populated. Ie: username, the reason for signature, comments, notes, etc.
eSignature tool that allows multiple people to sign the same document.
An easy to access digital audit trail showing signer, a timestamp of signature (date and time), a reason for signature, and the version signed.
System Auto-logout feature after a set amount of time of inactivity
Advanced eSignature Features of a Purpose Built eRegulatory and eSource Solution
Sign-By-Date: Built-in safeguards that request a document to be signed by pre-determined date and time. Ensure time-sensitive documents are signed as needed to meet important study timeline goals.
Alerts: Email or dashboard alerts for when a signature has been requested and when a signature has been completed.
Launching eSignatures into your clinical trial workflow introduces significant time-saving benefits, however, it is vital that you ensure the system and processes you use are fully compliant and secure.