This is an "Ad Hoc" Sample Allocation process, which creates a unique identifier for each Sample.

Allocated Samples do not represent existing Samples until they are received.

From the Allocated Samples List page, click "Allocate Sample".

In a new window, you are asked to define the number of different Samples you would like to create (Copies). The "Add Multiple Samples" button adds a corresponding number of rows to the Sample Allocation page. Define the Samples you want to Allocate and click "Allocate Samples".

After creation of the Samples, you are forwarded to an Allocated Samples List page containing the newly created Samples.

Creating multiple Identical Samples

The "Allocate Samples" button allows you to add multiple, identical Samples at once.

The "Batch Allocate Sample" operation allows allocation of 200 to 300 Samples in one operation.

This page includes the columns Study Id, Allocated For, Allocated Site, Sample Type, and Number of Copies.

As with Ad Hoc Sample Allocation, control returns to the Allocated Samples List page.

Editing is done in the Sample Maintenance page.

These are several of the tabs, from the Sample Maintenance pages, displaying fields from both the Sample and SampleFamily records:

A toolbar is at the top of Maintenance Pages. Following is a discussion of major tools on the bar.

SDI Security lets you grant a set of Users, Job Types (Users assigned the Roles and SDC Access for the Job Type), or Departments (Users in the Department) permission to perform a set of SDC Operations on selected SDIs. Manage SecuritySet lets you define a new SecuritySet or choose an existing SecuritySet. See Concepts of LabVantage Security → SDI Security for details about defining Security Sets.

This opens a Maintenance page to edit Sample Family-related fields, manage the Documents for the Sample Family and view the Samples contained in the Sample Family.

This opens a Maintenance page to edit Trackable Item-related fields. This is used to modify the current quantity or change the Container. Freeze-Thaw attributes for the Sample can also be modified:

Exceptions to the general Sample receipt process can occur when a laboratory receiving Samples is not defined as a Repository. Some laboratories will have the ability to confirm a Sample's existence at the facility and perform a limited set of operations on that Sample prior to sending it to a Repository.

Users are prompted to select a Custodial Department to which these Samples are assigned for the "Temporary In Lab" status. The list of Custodial Departments is limited to Custodial Departments to which the user is assigned, and Custodial Departments with the "Temporary In Lab Status" flag is set.

You can manage Samples with a status of "Temporary In Lab" into storage locations. If you want to transfer these items, the destination must be a Custodial Department with the Repository flag set.

External facilities occasionally submit Samples to the laboratory. Typically, Samples are submitted to leverage the high throughput capabilities of molecular technologies. In this case, the submitting personnel must register their Samples in BioBanking with a set of basic information. Samples that are registered by an external facility have a status of "Allocated".

This process is similar to the Sample Allocation process. However, you must enter more information about the Sample being submitted.

Studies that are created for the purpose of "External Submission" (type of "Externally Submitted") must have the following attributes set:

This will permit full approval of the Sample with limited accessioning data entry required by the Repository receiving the Samples.

Should you need to change the Study on an existing Sample (after the Sample has been Allocated or Received) you can do so using the Change Sample Study operation in the Sidebar. This operation is available on the following List pages:

To change the Study on a Sample(s), select one or more samples from the list page and click "Change Sample Study" in the Sidebar.

Auxiliary Studies allow you to run additional Tests on a BioBanking Sample under a different Study. The Study under which the Sample is Collected and Accessioned is the Primary Study, any other additional Studies become the Auxiliary Study. A sample can only have one Primary Study but can have multiple Auxiliary Studies.

The Add Auxiliary Study operation can be performed from the following List pages:

To add an Auxiliary study, select one or more Samples and click "Add Auxiliary Study" (More tasks, Other Tasks). The following window opens displaying the selected sample(s).

Enter the Auxiliary Study you want to add to the selected samples and include a reason.

LabVantage checks that the Study is not already a Primary or Auxiliary Study on any of the Samples.

If the new Study has Tests defined LabVantage displays those tests for each sample based on Sample Type and the Study Test definition.

If the Sample already has a test defined, the status of the Test is shown and the following options are given:

If Tests are not defined on the Sample the following options are given:

Once you have determined which Testing should be done for the new Study enter a reason and click "Add Study". The study is added as an Auxiliary Study on the Samples, any Tests are ordered and the Sample List is refreshed. The list page now shows an icon to indicate that the samples have an Auxiliary Study.

Clicking the icon displays a dialog that details the Auxiliary Study.

The Sample Maintenance page displays any Auxiliary Studies for the Sample in the Auxiliary Studies tab.

Typically Samples are Received and Accessioned using the Receive and Accession Samples task. Accessioning Data Entry allows Data Managers to enter data for a Sample that was not Accessioned at the time of receipt or requires editing. Changes made during the Accessioning Data Entry process, as well as subsequent editing, require users to provide a reason for change.

From a Sample List page, users search for Samples requiring Accessioning Data Entry. They can then choose all (or a subset of) the Samples and click the "Accessioning Data Entry" button. This directs the user to the Accessioning Data Entry page.

Some Studies require that another party perform additional verification or authorization on a Sample prior to its release to circulation. In some cases, Samples may also travel to a separate group or entity to verify or enter additional information about the Sample.

To require additional verification for a Sample navigate to the Accession Samples page (the "Accession Samples" button is available on most Sample list pages).

Click the "Request Verification" button. The Sample status becomes "Verification Needed" and the Sample moves to the Data Entry list page where you (or others) can "Perform Additional Verification".

Samples that have a status of "Verification Needed" must undergo this verification step before the Sample can be released to inventory, and its status changed to "In Circulation".

Perform Additional Verification

From the Data Entry List page, select a set of Samples having "Verification Needed" status. Click Lifecycle → Perform Additional Verification to review the Sample data to be verified. For the selected Samples, the user must be either the Data Manager and/or have the role assigned to the "Verification Role" field for the Study attributes of the selected Samples, or (when using Restriction Classes) the user assigned to the "Verification By" field for the Study attribute of the selected Samples.

From the Lifecycle menu, upon clicking "Perform Additional Verification", you are taken to the Accessioning Data Entry page as described in the Accessioning Data Entry section. You can view and modify the data:

The page contains two relevant operations:

"Save" saves edits to the data.

"Verification Complete" completes the verification process, the status changes to "In Circulation".

These operations are accessible from the Data Entry Sample List, Accessioning Data Entry Grid and Accessioning Data Entry Form pages (see Accessioning Data Entry).

The "Approve" operation changes Sample status to "In Circulation" after the system verifies that all information entered for the Sample has met the approval requirements defined in the Sample's Study.

The "Conditional Approve" operation approves Samples (putting them into circulation) for the user with the Conditional Approval flag set, thereby allowing full approval (through use of the "Approve" operation) when all required information has been supplied.

This adds Treatments to a Sample, either independently or after preparation/derivation. Treatments that can be applied after derivation also depend on the Sample's Sample Type. Treatments can only be added to Samples with the same Sample Type.

This is done from a Sample List Page ("Add Treatment"):

Define a plan that creates Aliquots and Derivatives from new or existing Samples. See Child Sample Plans for information.

This places items in temporary storage locations while they are being used or awaiting a function (such as unpacking or shipping).

You can place these items in temporary storage:

On the relevant List page (Sample, Plate, Box, or Package), operations exist for assigning items to temporary storage. Using the standard search capabilities of List pages, search for Samples to place into temporary storage. By selecting all or a subset, you can click the appropriate operation to assign storage.

During assignment of storage, all previous temporary storage locations are cleared.

Check In returns Samples from a user's custody (you must be a member of the Sample's Custodial Department) back to the storage system.

From a Sample List page, query Samples to check in. Select the Samples and click "Check In". The File Samples page displays.

Take Custody lets Users take (or force) custody of a Sample.

From the Sample List page, select the Samples you need to Take Custody of and click "Take Custody". The Take Custody Dialog displays.

See Move Samples → Take Custody for more information.

Custodial Department Transfer lets you move Samples between internal departments that are in close proximity and do not require shipping.

From the Sample List page, select the Samples you need to transfer and click "Transfer". The Transfer Dialog displays.

See Move Samples → Transfer for more information.

From a Sample List page, create Sample Aliquots by selecting the desired parent Sample(s) and clicking "Create Aliquot". This opens the Aliquot page:

This information is shown for the parent Samples:

Enter the following information for the aliquots. Aliquots using different templates can be created by clicking the "Add" button to add rows to the Aliquots tab:

Add Child Samples to a Different Study

Optionally, choose to add Child Samples to a Study different from the Parent Sample. When enabled (the "Allow Selection" option in the Child Sample Study Selection property on the Multi Sample Child Page Type is checked), the Study lookup displays on the Child Sample Creation page. Choose the Study with which you want to associate the Child Sample.

Child Samples associated with a different Study will have their own Sample Family with the new Study.

If no previous relationship exists between the Study and the Sample's Subject a new Participant record is created for the Child Sample. The Sample Family will reference the new ParticipantID, and the SubjectID as well as the Clinical Site and Clinical Event from the prior Sample Family. The Participant will have a status of "Associated", indicating that the Participant is not enrolled in the second Study only that their Sample is used in the second Study.
Associated Participants will have limited operations available and will not appear in Participant Lists during Enrollment.

The Sample status is set to "Received". Once the Child Samples are added, you are taken to the SMS Data Entry page (default) to enter Sample related data under the new Study.

Tests defined in the new Study, matching the Sample Type of the Child Sample, are also added to the Child Samples. Documents from the new Study that are to be added "on Allocation/Creation" are also added to the Child Samples.

If the Study is left blank the Child Sample is added with the Parent Sample's Study.

From a Sample List page, create Sample Derivatives by selecting the desired parent Samples, all with the same Sample Type, and clicking "Create Derivative". This opens the Add Sample Derivatives page:

This information is shown for the parent Samples:

Enter the following information for the derivatives. Derivative Samples using different templates, or of different Sample Types, can be created by clicking the "Add" button to add rows to the Derivatives tab:

Pooling is the act of combining multiple Samples into a single, composite Sample. Users can select any number of Samples of the same Sample Type and pool them together to create a new Sample.

From a Sample List page, choose the Samples to pool together, then click "Pool Samples". This opens the Create Pooled Samples page:

This information is shown for each parent Sample:

Enter the following information:

From a Sample List page, this operation opens the Accession Samples page for daily data entry.

Available on the Sample Admin List page, opens the Fix Sample Accession Data page. This lets you correct any errors made during Accessioning.

A warning message is displayed to remind you that changes made here may have a significant impact on other data within the application.

The following example shows the Fix Sample Accession Data page:

This adds and applies Services to a Sample(s). This allows Laboratory testing results to be recorded against the selected Sample(s).

This is done from a Sample List Page after selecting one or more Samples ("Add Services"):

This allows you to add or remove Services associated with a Sample. From the Sample List page select one or more Samples and click "Manage Services". The many to many dialog displays. Choose which Services to include on each Sample.

From a Sample List page, this operation loads the selected Sample into an Array.

From a Sample List page, this operation opens a Data Entry page for Sample Test Results data entry.

From a Sample List page, this operation opens a Test Approval Data Entry page for Sample Test data approval.

This allows entry of a negative condition assessment to the Sample via the Lab Investigations module.

Deviations can be recorded either from the package-unpacking TISM page, or from the Laboratory Operations Sample List page. From the Sample List page, select a set of Samples against which you want to record a deviation, then click "Record Deviation (Lab Investigations)". Select the CAPA Incident template from the dropdown:

For Samples on the TISM page, select the Sample and then click "Add Deviation" to open the same Lab Investigations Incident template selection window.

Upon clicking "Save" a Lab Investigations Incident is created and associated with the selected Samples. The Lab Investigations Incidents can be accessed and processed from the Incident List pages.

This allows entry of a negative condition assessment to the Sample.

Discrepancies can be recorded either from the package-unpacking TISM page, or from the Laboratory Operations Sample List page. From the Sample List page, select a set of Samples against which you want to record a discrepancy, then click "Record Discrepancy". For Samples on the TISM page, select the Sample and then click "Add Discrepancy". The Enter Discrepancy dialog displays.

You can record the same discrepancy multiple times for a single Sample. Each discrepancy is associated with the person recording the discrepancy and the date it was recorded.

You can view discrepancies by clicking the Sample identifier (shows a Sample detail view).

Procedures are a list of processes that can be recorded against a Sample to meet the Sample"s COC and GLP requirements.

This is done from a Sample List page ("Record Procedure").

This prompts for an electronic signature and reason for change.

This takes an item out of temporary storage (reverses the Assign Storage operation).

On the relevant List page (Sample, Plate, Box, or Package), operations will exist for removing items from temporary storage. Using the standard search capabilities of List pages, search for Samples to remove from temporary storage. By selecting all or a subset, users can then click the appropriate operation to clear storage.

3rd Party Transfer refers to the transfer of the material beyond the control of the facility.

Users perform a 3rd Party Transfer from a Sample List page ("3rd Party Transfer" button).

This operation prompts for an electronic signature and reason for change.

This adds general comments about a Sample. This is done from a Sample List page ("Add Comment"). A dialog prompts for the comment in a text field:

A running list of comments is maintained for the Sample and viewed as a separate tab in the Edit Sample or View Sample pages.

Archiving is the permanent storage of a Sample for an indefinite period of time.

Users perform archiving from a Sample List page (the "Archive Sample" button).

This operation prompts for an electronic signature and reason for change.

When Aliquots, Derivatives and Pooled Samples are created, they are assigned a status of "In Prep". This is similar to "Allocated", except that Accessioning Data Entry is not required (because the Sample has a relationship to a parent Sample). The Sample exists in the laboratory only after it is physically confirmed as having been prepared (meaning physically aliquoted, derived or pooled).

From a Sample List page, select the Aliquots, Derivatives, or Pooled Samples that have a status of "In Prep". Then, click "Confirm Sample".

Sample Disposition broadly refers to the concept of recording the "final state" of a Sample. The "Disposed" Sample status is used for any state in which the Sample is not readily retrievable or accounted for. Disposed Samples cannot be moved, transferred, or acted upon in any way... unless they are moved back to "In Circulation" status.

Samples can undergo a disposition at any point in their lifecycle.

Users record Sample dispositions from a Sample List page (the "Dispose Sample" button). This prompts for an electronic signature, a reason for change, and to select a disposition from the DisposalStatus reference type.

This removes a disposition from a Sample, or places archived or 3rd party transferred Samples back into circulation.

This is done from a Sample List page ("Make Available" button).

This operation prompts for an electronic signature, a reason for change, and selection of a Custodial Department in which to place the Sample.

The user must select a Custodial Department of which he is a member.

This opens a page showing the Documents associated with the selected Sample:

This reverses the "Dispose" operation.

This is done from a Sample List page ("Remove Disposition" button).

This operation prompts for an electronic signature and reason for change.

This removes the GLP status of a Sample (sets the GLP flag to "No").

This is done from a Sample List page (the "Remove GLP" button).

This operation prompts for a reason for change.