InForm administration tasks

Manage global system settings

Set options that specify how the InForm application behaves globally. The system configuration settings control the behavior of the study for all users.

Configuration options include:

• Intervals at which user re-authentication and password changes are required.
• Whether users can enroll a subject with incomplete enrollment information.
• Whether users must enter a comment when responding N/A, Unknown, or Not Done to a query.
• Maximum lengths of CRF data entry controls and query text.
• Whether Secure Socket Layer is enabled.
• Whether Candidate queries close automatically.
• Whether a customer-defined database (CDD) is enabled.
• Whether unique subject identifiers are required across studies, sites, or not at all.
• Whether sponsor users are allowed to edit frozen forms.

• Modify System Configuration

Manage rights and rights group

Create and maintain groups of rights that give users permission to perform InForm tasks.

• Manage Rights Groups

  Note: You cannot make changes to the rights group in which you are a member.

Manage groups and item groups

Create and maintain groups that allow you to associate users who have similar roles in a study and allow them access to specific areas of InForm functionality.

• Manage Other Groups

Manage display overrides

A display override is a property that is applied to a specific item, which overrides default display properties for all users. The display properties can be set to Hidden, Editable (default), or Read-Only.

This additional level of security allows you to give users with the same set of rights different access to specific items.

• Manage Rights Groups
• Manage Other Groups

Maintain rules

Maintain rules that specify how data items are calculated or validated, and define automatic queries that are generated when a data item does not pass validation criteria.

Rules are created with the Central Designer application and the MedML Installer utility.

At least one rule administration right:

• Deactivate a Rule
• Run a Rule
• Modify a Rule

Maintain events

Maintain the study components that specify the action to take when a rule fails.

Events are created with the Central Designer application and/or the MedML Installer utility.

At least one rule administration right:

• Deactivate a Rule
• Run a Rule
• Modify a Rule

Manage sites

Site definitions specify address and contact information about a study location. Sites are associated with specific users, and this association determines the data to which users have access.

Manage Sites

Manage users

A user, or user account, identifies who can access an InForm study. Users are associated with sites, rights groups, and other groups (query, signature, and reporting).

Each user can be associated to multiple sites and reporting groups, but to only one rights group, one query group, and one signature group.

• Create User
• Modify User Information
• Activate Site User
• Deactivate Site User
• Activate Sponsor user
• Deactivate Sponsor User
• Terminate User
• Un-Terminate User

Transfer subjects

The InForm subject record transfer feature allows you to transfer subject information from one site to another.

You can transfer subjects one at a time using the InForm user interface, or you can transfer subjects in bulk using the InForm Data Import utility tool. For more information, see the Utilities Guide.

• Subject Transfer

Define custom review states for the Data Viewer

The system administrator for the study must install MedML that contains the definitions for the states. Custom review states cannot be defined using the InForm user interface.

To assign and view the custom review states in the Data Viewer:

• Access Data Viewer / Data Export Listings
• One or more of the following:
  • Assign Review State 1
  • Assign Review State 2
  • Assign Review State 3
  • Assign Review State 4
  • Assign Review State 5
• View Review States

Configure partial source verification

You can decide whether all the data marked as SV Required during study design must be source verified, or if the amount of data to be source verified can be reduced using partial source verification (Partial SV).

• Mark and Unmark a CRF as SVed
• Change Site SV Settings
• View CRF