Record Sign Off (eSignatures Review)
Records progressing through the review levels defined on a study often require eSignatures at one or more levels. This is commonly done by a Site Investigator as a final review step but can differ among studies
Records available to review can be accessed via the Action Item Report on both the mobile app and website.
The ability to sign records individually is based on a user’s role.
To perform review and signatures in batches, or to bypass record sign off on subsets of records are functions that can only be performed if the user’s role has been granted the corresponding permissions. Batch and bypass review can be done from the Action items report
There are three methods for providing eSignature within TrialKit:
Traditional username/password entry - Web browser and mobile app
Handwritten (Analog) signature - mobile app only
Biometrics - mobile app only on devices with biometric support
When a signature is provided the system logs the event, user, date, and signature type utilized. This information is presented in audit trails with other information.
From the mobile app:
On the signature window, the handwritten option will be the default. Biometric or Sign In option can also be selected if preferred.
High Volume Batch Review/Signature Locking
A separate function exists for instances where there are large volumes of records requiring batch review. In these instances, for example, an user may spot-review a subset of records and then sign off on all the records for a given form and a given site.
Unique permission must be granted to access this function. By default this is disabled for all user roles. Study Admins can grant it here:
When enabled, users will see this option on the Subject Manager screen:
When use, the user will be presented with options to select a site, form, and level that records should be locked at. The current user will be limited to their own sites and assigned review level.
Once executed a number of records locked will be displayed for reference.
This function does not check which forms are ommitted from review levels. For example, if the Registration form is ommitted from Investigator review in the study design, the action items report will account for that, but the volume batch lock function will not. In other words, the Investigator would still be able to sign off and lock all Registration records at their own level.
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