Request subject unblind
A subject unblind request refers to the process when authorized users request access to a subject's treatment assignment information, typically undertaken in situations where knowledge of the assigned treatment is deemed crucial for medical or ethical reasons. The request is sent when the subject's details, such as an arm name and the event history, need to become visible to both blinded and unblinded users across eClinical.
Important
You can skip the unblinding request step if it is irrelevant to your study. Under the Study Information tab of IWRS, you can customize if the unblinding requires approval.
After the subject unblind request is sent, a user with appropriate IWRS permissions needs to review the request by learning the unblinding circumstances and then decide whether to revoke or approve the request. If the request is approved, the data for a corresponding subject can be unblinded afterward.
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In the IWRS application header, select the SUBJECT tab.
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From Subject List that opens, select the needed site and subject.
Figure 1. Selecting site and subject
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Under the Subject Information subtab that opens by default, select
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Figure 2. Requesting subject unblinding
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In the Request Unblind dialog that appears, enter the reason for requesting the subject unblind and then select
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Figure 3. Providing reason for subject unblind request
Once saved, the subject unblind request is sent. You now need to wait for an authorized user to approve the request so you can actually unblind the subject.