Storing handwritten signatures electronically
    • 27 Sep 2024
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    Storing handwritten signatures electronically

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    Article summary

    Your signatures in StudyWorks

    StudyWorks captures signatures from Site personnel for specific tasks, as defined by the study design. These tasks may include:

    • Saving a draft form;

    • Submitting a form;

    • Approving a form;

    • Returning a form;

    • Locking or unlocking a form;

    • Verifying the source of fields;

    • Sending a message;

    • Deleting a form or subject.

    In this article, we take a deeper look at what’s included in your electronic signature, where it’s stored, and how we handle signatures in accordance with the General Data Protection Regulation (GDPR).

    Information Scope

    Solution: eCOA

    Platform: StudyWorks

    From handwritten signatures to eSignatures

    Handwritten signatures are cryptographically stored as vector maps in the StudyWorks database. Access is restricted through validated controls, ensuring only authorized Site users and GDPR-compliant personnel can view them for attribution and data integrity.

    If requested by the Sponsor, specific Clario personnel can mask the Ink Signature in the Audit Trail, displaying “Ink Signature removed by request” instead. This masking applies to all users and can be reversed by Clario at any time.

    Additionally, handwritten signatures are included in a Site’s archive at the end of a study.

    Example of a masked ink signature

    Affidavit

    The eSignature includes text explaining the signature’s meaning, as defined by the study designer, is automatically displayed for the related action.

    Username

    The eSignature includes the signer’s StudyWorks username or the signature captured from their device.

    Password

    The eSignature contains the signer’s StudyWorks password or device PIN/password but this information is not displayed in records; rather, it is used with the Study ID and username for verification.

    Timestamp

    Included in the eSignature is the time the signature was added to the record.

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