Video overview

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User Accounts

Timeout Minutes

This is the system-wide inactivity period for users after which they will be logged out of the system. This can be adjusted on a per user basis.

Password Requirements

You can define the system-wide password requirements:

• Password minimum length

• Alphanumeric Passwords?

• Special Character Passwords?

• Password Expire Days

• Reject Reuse of Previous Passwords

Maximum Fail Attempts

Define the maximum failed login attempts before a user gets locked out. Please note that users can still use the “Email reset” link during their lockout time.

SignOffs

Username and Password Required with Sign?

If this box is checked, the users will have to provide their username and password with each signoff.

If this box is unchecked, the users will have to provide their username and password with their first signoff in a session, but they will only need to enter the password on subsequent signoffs.

This is a system default, but it can be overriden for each Study.

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Study specific over-ride for eSignature mode

Signoff Meaning

Signoff Meaning is the text that will be displayed to the user on the signoff screen.

The Signoffs can occur in the following areas:

• Lab Review

• Review of Study Data

• Various Approval Signoffs

Approvals

The Approval Requirements section is dedicated to configure the approvals for various study design elements system-wide. These settings cannot be adjusted on a per Study basis.

To add an Approval Requirement, click the “Add” button and select the Role that the user signing off on the item needs to have.

When no approval requirements are defined, these elements will not require a specific approval with a signoff.

• Activity Plans - if an Activity Plan does not require an approval, the users can simply change the Activity Plan from Design to Ready.

• ECG Interval Study Configurations - if ECG Review Settings do not require an approval, it can simply be locked.

• Eligibility Mappings - if the Eligibility Mapping does not require a signoff, it can simply be locked.

• Informed Consents - if an Informed Consent does not require approval, it can simply be added to the Study.

• Sample Paths - if a Sample Path does not require an approval, it can simply be locked.

• Study Lab Panels - if a Lab Panel does not require Approval, it can simply be locked.