Signing and unsigning at the patient, visit, form, and item levels
A user with the appropriate rights—typically, an investigator or clinical research coordinator—signs each item and form after all corrections have been made, signs each visit after all the forms in the visit have been signed, and signs a patient after the visits have been signed.
Note: By default, signatures at each level are independent of each other. For more information, see Signatures and the OutcomeLogix object hierarchy. However, when you sign a patient, visit, or form, the status Signed as Parent is assigned to repeating sections.
Unsigning a visit, form, or item indicates that the data entry is no longer considered complete. You can sign frozen forms, but you cannot sign locked forms. If you change data when you respond to a query or update the form, you must re-sign the visit, form, or item.
A signing history also appears on the Audit Trail page.
To sign a patient, visit, form, or item:
- Select Patients (
).The Patient List page appears.
- Click the Summary link for the patient.
The Patient Summary page appears.
- Select the checkbox to the left of the patient, visit, form, or item.
- Click the Sign icon (
).A window opens for you to attest to the accuracy and completeness of the data.
- From the Reason drop-down list, select the reason for your signature. If you selected Other as the reason, type an explanation in the Reason text box.
- Type your User Name.
- Type your Password.
- Click Submit.
The OutcomeLogix application displays the Signed status icon in the Status column for the signed patient, visit, form, or item.
Note: Alternatively, you can sign a form after you enter the data into the form by selecting the Sign (
) icon and following steps 5 – 8.
To unsign a patient, visit, form, or item:
- Select Patients (
).The Patient List page appears.
- Click the Summary link for the patient.
The Patient Summary page appears.
Signed items have a Signed icon in the Status column.
- Click the checkbox to the left of the signed patient, visit, form, or item.
- Click the Unsign icon (
).The OutcomeLogix application removes the Signed status icon from the selected patient, visit, form, or item.
Note: Oracle recommends that you do not sign a form, visit, or patient until all data is complete, source verification is performed, and all queries are resolved.
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