Administrative Tasks

The following topics are for Candid Administrators. Administrators manage user accounts, drop-down menus and other system-wide configuration options.

Manage User Accounts

1. In the upper, left-hand corner, under your name and system role, click the organization name.
2. Click the Settings button.
3. At the bottom of the list, click the Users link.
4. Candid provides a summary of current users; the details are listed in 7 columns:

Add User

Add User Account

1. In the upper, left-hand corner, under your name and system role, click the organization name.
2. Click the Setting button.
3. At the bottom of the list, click the Users link.
4. Click the Add button.
5. Complete the form.
6. Click the Save button (or click the Cancel button to exit the form without saving).

Change User's Organization Access

1. Click the Settings button.
2. Click the Organization button.
3. Under the Users column, click the Users button.
4. Start typing the new user's name into the search box.
5. Once the user's name shows in the list, click on it.
6. Click the Add button.
7. To revoke a user's access to an Organization: click the red icon next to the member's name to remove access.

Disable User Accounts

1. In the upper, left-hand corner, under your name and system role, click the organization name.
2. Click the Settings button.
3. At the bottom of the list, click the Users link.
4. In the Actions column, click the Edit button.
5. Uncheck the box next to Current Employee.
6. Click the Save button.

Unlock User Accounts

If a user enters an incorrect password more than 5 times, Candid will lock their account and will require an Administrator to unlock the account.

To unlock a user account:

1. In the upper, left-hand corner, under your name and system role, click the organization name.
2. Click the Settings button.
3. At the bottom of the list, click the Users link.
4. In the Actions column, click the Edit button.
5. Check the Unlock User Account checkbox at the bottom of the user’s editable details.
6. Click the Save button.
7. Have the user access the login page and follow the process for resetting their password (see Changing Your Password).

Organizations

Some organizations, such as CROs or large firms, may wish to securely separate analyses between different teams. Candid has built in support for multiple organizations per customer.

In a multi-organization configuration, Candid will securely separate analyses by each organizational context. Administrators control user access to each organization ensuring each user will be able to see only those analyses within their assigned organizational context.

Organizational Context

The name of the current organization context is shown in the upper, left-hand corner of the screen, below the logged in user’s name.

Change Organizational Context

1. In the upper, left-hand corner, under your name and system role, click the organization name.
2. Candid will display a list of organizations you are allowed to access (organization access is managed by Administrators).
3. Click the name of the organization and Candid will redirect you to your default dashboard inside that organizational context.

Add Organization

1. In the upper, left-hand corner, under your name and system role, click the organization name.
2. Click the Settings button.
3. Click the Organization button.

Controlling User Access to Organizations

View, add, or remove user organization assignments.

1. In the upper, left-hand corner, under your name and system role, click the organization name.
2. Click the Settings button.
3. Click the Organization button.

To add a member:

1. Start typing the new user's name into the search box (the new user must already be added to the system [see Adding User Accounts]).
2. Once the user's name shows in the list, click on it.
3. Click the Add button.

To remove a member:

1. Click the red icon next to the member's name to remove them.

Products & Studies

Candid allows you to manage the list of products and corresponding studies that your team can use to organize work across analyses. To view the list of configured products, click the Products main menu item.

Product Index

To view the list of products click the Products main menu link. You can access the study (data source) list for each product by clicking the 12 Studies (where 12 is the number of studies (data sources) associated with that product).

Study Index

To view list of studies and other data sources click Studies & Data Sources main menu link. Or, access them from the Products index (see above).

Add Products

1. In the main menu, on the left-hand side, click the Products link.
2. Under the Products section, on the left-hand side of the page, click Add Product button.
3. Complete the Create Product form.
4. Click the Save button (or click the Cancel button to exit the form without saving).

Edit Products

1. In the main menu, on the left-hand side, click the Products menu.
2. In the Products section, click on the link that corresponds to the product you would like to edit OR scroll down the list of products on the right-hand side until you find the product you would like to edit.
3. Click the View & Edit Product button.
4. Edit the following fields in the Edit form.
5. Click the Save button (or click the Cancel button to exit the form without saving).

Adding and Editing Studies

Add Study

1. In the main menu, on the left-hand side, click the Studies & Data Sources menu.
2. Click Products & Studies link.
3. Under the "Products" section, click on the link that corresponds to the product under which you would like to add a study OR scroll down the list of products on the right-hand side until you find the product under which you would like to add a study.
4. Click the Add Study button.
5. Complete the "Add Study" form.
6. Click the Submit button (or click the Cancel button to exit the form without saving).

Edit Study

1. In the main menu, on the left-hand side, click the Studies & Data Sources menu.
2. Under the product name, the associated studies will be listed.
3. Click on the Details button to view the details of the study Underneath the Details button, if there are associated Analyses, click on the Analyses** button to go to the "Analysis Index" page, filtered so only Analyses related to the selected product are visible.

Default Team

If some or all of the same people will be working on a study together, you can set up a default study team that will automatically be added to any new analysis that is created for that study. Users on the default study team will automatically be assigned to Analysis roles according to their system role (see Roles & Security).

Add Default Team Member

1. From the Products & Studies page, click on the Details button to go to the Study Details page.
2. On the right-hand side, under the "Default Team" section, click in the text box to access the list of available team members.
3. Select the desired team member by clicking on their name.
4. Click the Add button.

Remove Default Team Member

1. Under the "Default Team" section of the "Study Details" page, locate the default team member you would like to remove.
2. Click the red next to the team member's name.

About Role Mappings

When a new analysis is created, the user starting the new analysis will be assigned as the Statistician Owner or Programmer Owner (depending on the user's system role). All users defined on the default study team(s) are assigned to analysis roles (based on their system roles) according to the following mappings:

Other Data Sources

Studies are the primary data source for analyses, but sometimes analyses are performed using data from other databases or system. Other Data Sources allows you to do this.

Add Other Data Sources

1. In the main menu, on the left-hand side, click the Studies link.
2. Click Other Data Sources link.
3. Under the Products section, on the left-hand side of the page, click Add button.
4. Complete the Create Product form.
5. Click the Submit button (or click the Cancel button to exit the form without saving).

Edit Other Data Sources

1. In the main menu, on the left-hand side, click the Studies menu.
2. Click Other Data Sources link.
3. In the Products section, click on the link that corresponds to the product you would like to edit OR scroll down the list of products on the right-hand side until you find the product you would like to edit.
4. Click the Edit Product button.
5. Edit the following fields in the Edit form.
6. Click the Submit button (or click the Cancel button to exit the form without saving).

TFL Templates

The TFL Template Library is a place for you to define sets of TFL metadata (titles, footnotes) . These templates are can be used to automatically add TFL metadata to analysis projects.

Each TFL template defines the common metadata for a type of TFL. The template specifies the type, class, name, number, program, titles, and footnotes that will be used when creating instances of this TFL for an analysis.

Titles and footnotes use a special token system allowing your team to dynamically replace these tokens with your own content. See the Title & Footnote Tokens section below for more details.

Title & Footnote Tokens

Template titles and foonotes are simply text. When a TFL is created using a template, the pre-defined titles and footnotes will be created automatically. Often there will be a set of TFLs that are all very similar except for one small difference in a title or footnote. The token system is designed to handle this situation elegantly.

Required Tokens

Tokens are defined by enclosing a token name in curly brackets (e.g. {TOKEN_NAME}). An example of how this looks in practice is below.

Template Title: Serious Adverse Events by {AE_GROUP}

Using the template above, the following TFLs could be created (note the user-supplied text in red that replaces the {AE_GROUP} token):

TFL Instance 1 Title: Serious Adverse Events by Age TFL Instance 2 Title: Serious Adverse Events by Sex TFL Instance 3 Title: Serious Adverse Events by Dosages

Optional Tokens

There are two additional types of token. Optional tokens are tokens that may be left blank by the user, if desired. An optional token is enclosed in curly brackets, followed by a single colon before the token name (e.g. {:OPTIONAL_TOKEN_NAME}). Below is a practical example of optional token usage:

Template Title: {:AE_TYPE} Adverse Events by {AE_GROUP}

Using the template above, the following TFLs could be created (note the user-supplied text in red that replaces the {AE_GROUP} token and the user-supplied text in green that replaces the {:AE_TYPE} token):

TFL Instance 1 Title: Adverse Events by Age (the {:AE_TYPE} token is omitted) TFL Instance 2 Title: Adverse Events by Sex (the {:AE_TYPE} token is omitted) TFL Instance 3 Title: Serious Adverse Events by Dosages

It is also possible to have the entire title or foonote be a token:

Template Title: {:TITLE_3}

This example will let the user optionally define a third title or leave it off.

System Tokens

System tokens are automatically replaced by Candid and cannot be modified by the user. This type of token is defined by prefixing the token name with a dollar sign (e.g. $SYSTEM_TOKEN). There are only two system tokens currently defined, $STUDY and $WORKING_DIRECTORY. An example of this in practice is below.

Template Title: Zeroarc Study $STUDY

Using the template above, the following TFL could be created (note the system-supplied text in red that replaces the $STUDY token):

TFL Instance 1 Title: Zeroarc Study ZA-0001

Add TFL Template Group

1. In the main menu, on the left-hand side, expand the Templates main menu item.
2. Click the TFLs link.
3. Under the "TFL Template Groups" section, the details of the template group are displayed.
4. Click the Add button to open the add form.
5. Click the Save button to add the group.

Edit TFL Template Group

1. In the main menu, on the left-hand side, expand the Templates main menu item.
2. Click the TFLs link.
3. Under the "TFL Template Groups" section, the details of the template group are displayed.
4. Click the Edit button to open the edit form.
5. Make your changes and click the Save button.
6. Alternatively, click the delete button to remove the TFL Template Group. Only Template Groups that have never been used to build TFL records on an analysis can and have no template items can be deleted.

Adding Document to a Group

1. In the main menu, on the left-hand side, expand the Templates main menu item.
2. Click the TFLs link.
3. Under the "TFL Template Groups" section, the details of the template group are displayed.
4. Click the Add Document button to open the form.
5. Click the large Click here or Drop to open the select document dialog box.
6. Select your file(s) and click the Open button.
7. Your selected files will automatically upload into the system.

Removing Document from a Group

1. In the main menu, on the left-hand side, expand the Templates main menu item.
2. Click the TFLs link.
3. Under the "Documents" section, click the red trashcan icon to remove the document.

Add/Edit Template Items

Add a Template

1. In the main menu, on the left-hand side, expand the Templates main menu item.
2. Click the TFLs link.
3. Under the "TFL Template Groups" section, the details of the template group are displayed.
4. Click the Templates button (where '#' is the total number of template in the TFL template group) for the TFL template group you would like to edit.
5. Candid will display a list of currently defined templates; from here you can add a new template or edit an existing one.
6. To add a new template, click the Add button to put the list in Add mode.
7. The Class and Type dropdown menus default to Safety and Table, however, you can change Class and Type to a value you administrator has defined in the system.
8. Complete the remainder of the form.
9. Click the Save button.
10. Continue adding another template or click the Cancel button to get out of add mode.

Edit a Template

1. To edit an existing template, click the Edit button to put the index in edit mode.
2. Edit any value in the grid. Your update will be saved as you cursor exits the edited input box.
3. Click the Stop Editing button to exit edit mode.
4. Alternatively, click the Delete button to remove the TFL entry from index.

Adding/Editing Template Titles and Footnotes

Add Title or Footnote

1. In the main menu, on the left-hand side, expand the Templates main menu item.
2. Click the TFLs link.
3. Under the "TFL Template Groups" section, the details of the template group are displayed.
4. In the Titles and Footnotes column click the Title and Footnotes button for the collection you wish to edit.
5. To add a new template, click the Add button to put the list in Add mode.
6. Complete the form.
7. Click the Save button.
8. Continue adding another or click the Cancel button to get out of add mode.

Edit Title or Footnote

1. In the main menu, on the left-hand side, expand the Templates main menu item.
2. Click the TFLs link.
3. Under the "TFL Template Groups" section, the details of the template group are displayed.
4. In the Titles and Footnotes column click the Title and Footnotes button for the collection you wish to edit.
5. To edit an existing Title/Footnote, click the Edit button to put the index in edit mode.
6. Edit any value in the grid. Your update will be saved as you cursor exits the edited input box.
7. Click the Stop Editing button to exit edit mode.
8. Alternatively, click the Delete button to remove a Title/Footnote from the collection.

User Groups

User Groups can be used to quickly add a set of users to Analysis Teams and Review Periods in a single step. Groups defined here are searchable in the Analysis Team and Review Period user drop down menu. When selected and submitted, all the members of the group will be automatically added.

Changing group membership or deleting a group has no effect on any previous application of that group to an Analysis Team or Review Period.

Add User Group

1. From the main menu select User Groups
2. Click the Add User Group button.
3. Enter a name for the group and click the Save.
4. Next add members to the group by typing in the input box to search the user list for a name. Once found hit Enter key or click the Add button.
5. Repeat above step for adding users.
6. Click Done to go back to User Group list.

To use the new group simple search for the group name and select it from the Analysis Team or Review Period user lists (see instructions for editing Analysis Team or Review Period team).

Edit User Group

1. From the main menu select User Groups
2. Click the button for the group you want to edit.
3. To add a new member to this group, type in the input box to search for a user and click the Add button.
4. To remove a member, click the button.
5. Click the Done button to go back to User Group list.
6. Click Done to go back to User Group list.

Editing user group membership has no impact on any previous application of that group to existing Analysis Team or Review Period team.

Delete User Group

1. From the main menu select User Groups
2. Click the button for the group you want to delete.
3. Click the Yes button when it becomes active to confirm.

Deleting a user group has no impact on any previous application of that group to existing Analysis Team or Review Period team.

User List

The User List is an index of Candid account users assigned to the current organization.

Administrators can add or remove users To or From this User List index. Full management of Candid accounts is done under Settings (see Manage User Accounts).

Settings

Editable Drop Down lists

Analysis Tasks

A drop down list to help categorize analyses by their intended purpose. The color fields are used for the doughnut chart analysis summary on the Overview dashboard.

Analysis Types

A drop down list to help categorize analyses by their 'work category' (e.g. Adhoc, Planned, etc.).

Dataset Classes

A drop down list classifying datasets (e.g. Events, Finding, Basic Data Structure). The values listed here are used to validate dataset class entries on the Candid define-xml Excel import template.

The sort order field is used to sort datasets in define.xml (Sorting is done by dataset class sort number 1st and then by dataset name within a dataset class.

Issue Categories

Issue Categories can be used to group issues. Your organization can have as many as you want or none. One way to use them is to quickly identify where a particular issue originated from or is related to (e.g. SAS Program, Raw Data, Query, Macros, etc.).

Test Methods

Identifies the different methods that can be used to QC/Test/Validate TFLs and Datasets (e.g. Independent Programming, Unit Testing, etc.).

TFL Classes

Used for classifying TFLs (e.g. Safety, Efficacy, Disposition, etc.).

TFL Groups

Used for custom, named groupings of TFLs (e.g. Topline, etc.).

Limited-editable Drop Down Lists

You can change the name or desciptions but cannot add or remove values from these lists.

Analysis Team Roles - not editable

Displays the available analysis team roles configured for your organization (e.g. Statistician Owner, Programmer, Reviewer, etc.). These are the roles a user can play on a given analysis.

User Roles

The available system roles configured for you organization (e.g. Statistician, Programmer, Administrator, etc.).