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- What is Electronic Signature?
- Where is it used in clinical trials?
- How does Clinion implement it?
- What does it look like in practice?
- Related Terms
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What is Electronic Signature?
An electronic signature (e-signature) is a digital way for a person to sign documents, showing their agreement or approval without using a handwritten signature. In clinical trials, it is used to confirm consent forms, approvals, or other official documents securely and legally. Electronic signatures are tracked with time stamps and linked to the signer, making them verifiable and auditable.
Where is it used in clinical trials?
An electronic signature is used throughout clinical trials to securely document approvals and agreements. It is applied when participants provide consent to join the study, when investigators or site staff authorize trial documents, and when regulatory or monitoring forms require verification. Electronic signature ensures that all records, such as consent forms, protocol acknowledgments, and data entries, are time-stamped, traceable, and auditable, helping maintain compliance with regulations and supporting the integrity and reliability of trial documentation.
How does Clinion implement it?
Clinion implements electronic signatures by providing a secure digital system for capturing, verifying, and storing signatures on all trial-related documents. The platform links each electronic signature to the signer, records the date and time, and tracks the document version. This ensures that consent forms, approvals, and data verifications are properly authorized, auditable, and fully compliant with regulatory requirements at every stage of the study.
What does it look like in practice?
In practice, an electronic signature looks like a participant or site staff member signing a document digitally using a computer or tablet. The system automatically records the signer’s identity, the date and time, and the document version. This allows staff to verify that forms, approvals, or consent records are properly signed and authenticated, creating a clear, verifiable, and secure record of all authorizations throughout the trial process.
Category
eConsent