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

      • 更新日 27 Sep 2024
      • 1 読む分
      • 印刷する
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      記事の要約

      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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