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The table below describes some of the configuration changes you can make through the Administration page as well as the impact of those changes on the study. Details of some of these settings appear in other chapters.
Note: Any changes made on the study or site level take effect the next time you sign in.
Configuration changes made through the Administration page
Configuration change | Page Performed On | Description | Notes |
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Auto unlock interval | Changes the number of minutes that must pass before the OutcomeLogix application automatically unlocks a locked user or patient. |
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Enable Repeat Visit Name | Indicates whether users can change the name that the application calculates for a repeating visit instance. |
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Initial password assigned to users | Changes the password that the application sends to users and patients to enable them to sign in for the first time. | If study designers specify a default initial password, all new users and patients automatically receive that password on creation. For security reasons, it is recommended that study designers leave the Initial password assigned to users field blank. That way, upon user creation, the new user receives a unique temporary password by email. | |
Password string | Changes the masking characters displayed in the Password fields. | Used for user and patient passwords. Length of the masking string does not match password length defined on the Password Rules page. | |
URL for accessing the study | Changes the internet address of the study. | You can specify only one URL.
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Study-specific message on the Sign In page | Displays study-specific information, notes, or reminders on the Sign In page. | Not translated; appears in the language in which it was entered. | |
ePRO due counts | Changes the number of days that must pass before an ePRO form is considered due and appears in the ePRO Status section of the Dashboard. | The ePRO forms included in the Dashboard count have reached or exceeded the number of days specified. | |
Session timeout | Changes the number of idle-time minutes before a user session times out. |
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Force session timeout | Changes whether a session can be forced to time out even if the user is active. |
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Second password reset question | Changes the number of reset questions on the Reset Password page so that users need to answer two questions before the password is reset. |
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Link expiration day | Changes the length of time a new user has to sign into the OutcomeLogix application for the first time after receiving a user name and password. |
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Whether to support sending emails | Changes whether the User Profile page includes the option of the user receiving email notifications. | Without this function, users do not receive notifications of password changes, site reassignments, and so on. | |
Help contact support email | Changes the email address of the Help Desk. |
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Showing patient profile core data | Indicates whether to show the core fields from the patient profile, such as email address, memorable date, reset password, and user name. | The study design determines the fields included on the Patient Profile page. | |
Study Name | Changes the study name at the top of the navigation bar on every page. | Might cause confusion if changed during an active study. | |
Sponsor Name | Replaces every occurrence of the sponsor name. | Might cause confusion if changed during an active study. | |
Therapeutic area | Provides additional information about the study protocol, such as Oncology, if set up for the study. |
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Expected number of sites | Number of sites that are expected to be part of the study. |
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Hide, mask, or make a form, or items within a form, read-only for selected roles | Hidden items do not appear on the Audit Trail page and are not included in reports. Masked items make Protected Health Information unreadable. Read-only items may not be edited. |
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Assign access to standard reports to roles | Allows users to access specific standard reports. |
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Password rules | Manage Password Rules page and Assign Password Rules to Roles page | Sets password parameters for selected roles, including time before expiration and the password default rule. | Might end up with many variations that are difficult to support. |
Rights groups | Creates a role and an associated rights group consisting of selected management and user functions. | Might end up with many variations that are difficult to support. | |
Localization settings | Changes the date formats, name sort options, number formats, and currency formats offered on the User Profile and Site Management pages. |
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Upload Informed Consent documents in multiple languages and of different types | Changes the list of available ICDs on the Site Management page. Determines which ICDs are active. | When a new version or different ICD is made active, all patients related to that ICD must re-sign it. | |
Destination sites associated with the study site | Associates destination sites with an originating site as required for patient transfers. |
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Site enrollment target numbers and limitations | Determines the maximum number of patients that can be enrolled, as well as target enrollment and limits. | The enrollment limit can exceed the target enrollment. | |
Activate or deactivate a site | Changes the status of the site. |
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Report server information | Specifies the location of the report server and allows the developer and viewer users to enter or change their passwords. |
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