Studies

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From the Studies Manager, users can view and add studies. The manager consists of a table displaying the studies with action buttons on the right side. Other options are available in the Studies Editor.

Users with appropriate permissions can also create Study Property Templates to streamline the process of creating studies.

The studies displayed on the manager can be filtered by pressing the Filter button at the bottom of the manager. This will open the Standard Search Dialog and allow users to change what studies are displayed. By default, the maximum number of studies displayed on the manager is 250. If more studies exist in the database, a user can use the Filter button to display the studies they want to find. (All studies can be displayed on the manager by selecting More > Limit Records Returned and selecting the Return all results option from the Filter's search dialog.)

On databases that support Study Level Security, administrators and primary investigators for a study can set study authorizations by user.

Individual studies can require a valid e-signature before certain actions via the E-signature Actions study property, for any combination of the following actions: new specimen commit, specimen updates, specimen location movements, and/or specimen deletions. A valid e-signature requires that the user enter their username and password, as well as a Reason for Change. The user will have 10 attempts to enter their username and password correctly, after which their account will be deactivated and their BSI session will close.

An e-signature can also be required upon specimen approval for inclusion in a requisition, via the “Study Owner (e-signature)” choice available in the Approval Process study property.

The user must select a Reason for Change from the dropdown list of options. These options can be edited by users with appropriate permissions via the lkup_reason_for_change code list in the Code Lists module.

If enabled, notifications can be sent via email to a specified address when a study is created and/or updated.

Example: Principle investigator Eratosthenes received a grant to study the relationship between exercise and heart calcification. He would like to keep his specimen data in BSI yet differentiate it from other specimen collections. To do so, Dr. Eratosthenes created a new study knowing that as specimen data is entered in BSI, each will have Dr. Eratosthenes’s unique Study name and ID associated with it. This will allow all of his specimens to be easily searched and reported on.

The Study Editor is used to display, create and edit basic study information. The available fields will vary depending on the database. Any errors that prevent a study from being saved will be shaded red in the Study Editor. Hovering the cursor (mouse) over the field with the error will display a "ToolTip" message describing the error.

Fields can be added to, and some fields can be removed from, the Study Editor via the Customization manager, if the user has the applicable permissions. The following fields are generally available in the Study Editor:

Study Properties

Created By - This field is not editable and is populated with the user ID of the user who created the Study.
Study ID - The ID for the study.
Study Name - The name of the study.
Status – Indicates whether the study is active or inactive. Inactive studies will not be available for selection in specimen data fields or other fields (batch properties, requisition properties, kits, templates, etc.). The study can be manually keyed as a value, though a warning will be displayed to the user informing them that the study is inactive.
- A system preference is available, called Advanced Study Deactivation, which will prevent studies from being marked as inactive if any specimens in that study exist with the following status values: In, Reserved, On Hold, or Discrepant. The system preference will also prevent specimens in the study from being added to batches and requisitions. Specimens already included in requisitions can have tasks added to and completed on them.
Password - This field can be used to enter a password for a study. BSI will prompt users for this password when an attempt is made to add specimens from the study to a requisition.
PI Name - The Primary Investigator for the study.
Requires Authorization - This option is only available on Study Level Security enabled databases. Set this field to True/Yes to restrict access to study information. See Authorize Users for a Study for more information.

Destruction Date - The date after which the specimens belonging to the study must be destroyed. Automatic emails are sent out 60, 30, 15 and 7 days before the Destruction Date and on the day of the Destruction Date. These emails are sent, by default, to the Study PI.
Destruction Notification Contacts - This designates who will be emailed automatically by the system for destruction notifications. If this field is left blank and there is a specified Destruction Date, then the Study PI will be contacted.

Requires Consent – Specimens in the study must have the associated subject’s consent. If the subject's consent hasn't been entered, a warning will be displayed when a user attempts to add the specimen to a requisition.

Approval Process - The current method of approving a specimen for inclusion in a requisition. Options include:

None
Study Owner (e-signature)
Study Owner (no e-signature)

Requisition Approver - The user(s) with appropriate permissions to approve specimens in the study being requested in a requisition. If no user is specified, the system will default to the PI of the study.
Attachment - This field allows users to upload and download documentation related to the study.
E-signature Actions – Each study can designate which, if any, of the associated action(s) will require the user to complete a valid e-signature before completing the action on specimen(s) in this study. The following actions are available for selection:

New Specimen Commit
Specimen Update
Specimen Location Movement
Specimen Deletion

Add a New Study

Users with permissions can create a new study from the Studies Manager.

To create a new study:

In the Studies Manager, press the New button. The Study Editor will open for a new study.

First, a Study Property Template may need to be selected from a list. The template chosen will default some data and display relevant property fields.

Enter information in the study fields. Required fields will be shaded red.

Property fields can be hidden or displayed using the Hide/Show button.

Select Save from the File menu or press the Save button. The new study should now be listed in the Studies Manager.

Note: if the system preference to automatically generate a Study ID is set, the Study ID will be populated when the study is saved.
The ‘study_format’ system preference will generate a Study ID, based on the format entered. The Format value must have the allowed number of characters or less for the Study ID field. When saving a new study, BSI will return a value within the Study ID Format that has not been used.
If the Client Editable Auto Generated Study ID system preference is set, only users with the Allow Manual Study ID Creation role permission will be able to manually override an auto generated Study ID.

The following rules are used for the Study Format:

Capital letters and special characters will not increment.
Lower case letters and numbers will increment.
If there are no unused Study IDs within the format then an error message will be displayed when the user attempts to save a new study.

View a Study

All users with permission to access the Studies manager can view basic information for a study, such as Study ID, Study Name, and PI Name. Users cannot view study passwords for which users are authorized. No information for a study can be changed by viewing it.

System Administrators and Local Administrators who are the PI of a study can view the Password field for that study. Users cannot view the Password field, both for studies requiring authorization and not requiring authorization.

To view a study:

Select the study to be viewed in the Studies Manager.
Press the View button. The Study Editor will open in view mode.

Edit a Study

Administrators and Primary Investigators (PIs) with the appropriate permissions can edit study information.

System Administrators and Local Administrators who are the PI of a study can edit the Password field for that study. Users will need to enter this Password when adding specimens in that study to a requisition.

To edit a study:

Select the study to be edited in the Studies Manager.
Press the Edit button. The Study Editor will open for editing.
Make any changes, as necessary.
Select Save from the File menu or press the Save button to save the changes.
- The changes will not be saved if any errors are present. Any fields with errors will be shaded red. Hover the mouse cursor over the field to open a tool tip with a description of the error.

Note: If the system preference to generate Study ID’s is set, the Study ID field cannot be edited and will be populated when the study is saved.

Delete a Study

A study that was erroneously entered or is not needed can be deleted from the Studies manager. Studies can only be deleted if NO records exist in BSI for that study. Administrators and Primary Investigators with the appropriate permissions can delete a study.

To delete a study:

Select the study to be deleted in the Studies Manager.
Press the Delete button. The study will be deleted from the manager.
- If any records exist in BSI for the study, an error message will be displayed and the study will not be deleted.

Authorize Users for a Study

On databases that have Study Level Security enabled, access to the study data can be limited to specific users by setting the Require Authorization property of a study to True. A study is set to require authorization in the Study Editor. Users can be restricted from viewing, submitting requisitions or shipments and modifying data for a study that requires authorization. Some restrictions are dependent on a repository's access level. See Study Level Security for more information on restrictions.

To authorize users for a study:

Select the study that is to have users authorized in the Studies Manager.
Press the Authorize button. The Study Authorizations dialog will open. The dialog contains a list of available users and users already selected for access to the study.
Select the user that is to have authorizations granted from the Available Users list.
Press Add Selected. The user will be added to the list of Selected Users. All users in the list of Selected Users have the ability to view data for the study.
- Check the box next to Default all permissions for newly added users to true to set all authorizations for the selected user to True when the user is added to the list of Selected Users.
Set the specific authorizations for the user by changing the value to True/Yes in the corresponding column. For a description of authorization options, see the Study Level Security page.
Press OK to save the changes and close the dialog. Press Cancel to exit the dialog without making any changes.

To remove a user's authorizations for a study:

Select the study that is to have authorizations removed in the Studies Manager.
Press the Authorize button. The Study Authorizations dialog will open. All users currently authorized for the study will be listed in the Selected Users section.
Remove a specific authorization or remove all authorizations:
- Change the specific authorizations for the user by changing the value to false in the appropriate column.
- Highlight the user and press the Remove Selected button to completely remove the user from the list. (All authorizations will be removed.)
Press OK to save the changes and close the dialog. Press Cancel to exit the dialog without making any changes.

Study Warnings

It is possible to generate warnings for specimens added to a requisition when adding those specimens would cause the total volume or total number of specimens left in storage of a group to drop below a specified level. A group of specimens for the purpose of generating warnings is defined as the total number of records that have the same Sample ID and Material Type. BSI will calculate these values and generate warnings when a requisition is submitted for processing.

Users with the appropriate role permissions can create or modify these warnings. Additional authorization may be required on Study Level Security enabled databases.

To edit study warnings:

Select the study to modify warnings for in the Studies Manager.
Press the Warnings button. The Warnings for Study dialog will open.
Add the values specific to the desired warnings as necessary. Multiple warning specifications can be entered.
- Either the Minimum Vials or Minimum Volume must be entered for each row of the warning table. If both are entered, a warning will be generated if either threshold is crossed.
- Enter a Material Type, if desired. Leaving the Material Type field blank will apply the warning to all material types within the sample.
- Enter a Volume Unit, if desired. Leaving the Volume Unit field blank will apply the warning to all volume units within the sample. The Volume Unit must be filled in if there is a value for Minimum Volume.
Enter a number in the Label field for the warning. This will be used to identify the warning in notifications.
Select File > Save or press the Save button to save the warnings.

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