Overview	Top

A Study is a concept that uniquely groups a collection of Samples under a specific experimental premise or clinical Protocol. Generally studies are a set of Samples collected loosely from different sources that are to be used for a common purpose such as general discovery science. Each Sample is permanently associated with one Study.

LabVantage provides two types of Studies:

Study design can include any of the following:

Create a New Study	Top

Before adding a new Study you may need to define Study Template(s).

Note: Whether or not a Template must be referenced when adding a new Study is determined in Biobanking Policy.

Study Templates allow you to pre-define a typical Study, then reference the Template to default all the information defined here to a new Study. To add a Study Template navigate to Lab Admin → Templates → Study Templates. The Study Template List page displays. Click "Add".

All the details of a Study can be pre-defined in the Template, you can make changes to the defaulted information at the Study level. See Design the Study for detailed information about the fields on the Add Study Template page. Define general information about the Study including whether or not the Study is a Protocol or Non-Protocol driven Study. "Save" the information, a prompt for the Study Template Identifier is provided. Enter the Template ID and click "OK".

After saving, the detail tabs display:

Once Templates are defined you can Add a new Study by navigating to LIMS → Biobanking → New Studies. The Study List page displays. Click "Add". If prompted, select a Study Template and/or enter the Study Id for the new Study.

If you are not prompted for these initial values the Study Id must be entered on the Study Maintenance page.

Click "OK" to continue to the Study Maintenance page.

Whether designing a Study as a Template or adding a new Study directly you are presented with the Study Maintenance page.

The detail tabs that display are determined by whether you are defining a Protocol or Non-Protocol Study.

Protocol Studies

Non-Protocol Studies

All detail tabs are described in the following sections.

As part of the Study definition, you can specify both internal and external Contacts that are related to the Study. This is purely informational (tells who can be contacted about the Study), and has no functional behavior associated with these Contacts.

The list of Contacts is shown as a separate tab on the Study maintenance page. For each Contact you specify, you must indicate the function of that Contact person.

When Samples are collected as part of clinical Studies, registries, or license, there is typically a "consent" agreement that applies to the use of each Sample. Restriction Classes (RC) are used to represent these various "consent restrictions" and track them for every Sample. Tracking of the consent that applies to the Sample, and the chain of custody for the Sample, helps fulfill the legal responsibility to the patient who donated the materials.

Any Sample with a Restriction Class having the "COC Required" flag set must follow all COC procedures and record such procedures in order to preserve the Sample's exact location at all times.

Note: Depending on the configured BioBanking policies, no Sample can be received or approved for a Study unless the Sample is associated with at least one active Restriction Class. The system does not automatically create a Restriction Class for each Study.

There are several "basic" categories of restrictions that can apply to a Sample:

To represent these various restrictions, each Sample maintains a "Restriction Class" field that indicates the Restriction Class to which it belongs. Each Study defines one or more Study-specific Restriction Classes to model the restrictions on the Study's Samples. Each Restriction Class describes the limitations that must be followed for Samples assigned to it. Restriction Classes are recorded purely as a human decision support advisory. Human operators will read the Restriction Class for a Sample and ultimately make the decision as to how to enforce the requirements set forth in the Restriction Class. During Sample data entry, a Restriction Class from the Sample's Study is assigned to the Sample. When an aliquot or derivative of a Sample is created, the Restriction Class of the child Sample is the same as that of the parent.

From the Study Maintenance page, Restriction Classes Tab, the "Add Restriction Class" button opens the add Restriction Class maintenance page shown below:

After saving the Restriction Class you can optionally add another Restriction Class by clicking "Add Another" or "Close and Refresh". Restriction Classes display in the Restriction Classes tab on the Study maintenance page:

From this tab, you can choose any Restriction Class to edit or delete. When editing the Restriction Class, the previous Maintenance page is shown.

When creating a Protocol Study the Protocol detail tab displays. See Biobanking Protocols for detailed information about defining a Protocol Study.

Depending on the requirements of a Study, it may require an approval process before it can become active. The necessary steps for approval can be added or modified from the Approvals tab on the Study Maintenance page:

When full Protocol Studies are either not required or not available, Clinical Sites allows the definition of sites that apply to a particular Study. Each site is simply identified by a name. Operations are available to create, edit or remove sites. Sites that have been linked to existing Samples can be deactivated (by un checking the Active checkbox) if they are no longer applicable to the Study. This will remove the Clinical Site from any lists associated with the Study. Clinical Sites linked to Samples cannot be deleted.

As part of the Study Maintenance page, there is a tab for managing Clinical Sites:

The system supports the ability to manage a set of collection Sites that apply to a particular Study. Each site is identified by a name and can be associated with an existing Custodial Department or Shipping Location (Department field). Operations are available to create, edit or remove Sites. Sites that have been linked to existing Samples can be deactivated, by un checking the Active checkbox, if they are no longer collecting Samples. This will remove the Site from any lists associated with the Study. Sites linked to Samples cannot be deleted.

As part of the Study Maintenance page, there is a tab for managing Sites:

Editing a Site opens the Study Site Maintenance page and allows you to specify further attributes for the Site as well as define Contacts and Users for the Site. Site Contacts and Users function the same way and are managed the same way as Study Contacts and Users. From the Study Site Maintenance page it is also possible to list the Study Participants currently assigned to the Site.

The Site tab allows selected Kits to be shipped to specific Sites. Upon clicking the "Ship Kits" button, a Kits lookup dialog opens allowing you to select the Kits and how many to be shipped to the Site. This creates a Package ready for shipment to the Site with the destination already set to the selected Site. Only those Kits defined for the current Study from Generate Kits, or valid generic Kits that have not yet been shipped, can be selected for shipment to a Site.

For Protocol Studies only, each Site must also specify which Protocol revision is being used for the Site. This allows different Sites to be using variations of the Protocol within the same Study. A Site's current Protocol revision can be updated using the "Update Revision" button. A Grace Period for Sample receipt may also be defined for Protocol Studies if there is a requirement for Samples to be received within a strict time period after collection.

If new Documents are required for a specific Site, or existing Documents need to be edited, reviewed or submitted, use the "Manage Documents" button to open the Documents management page for the selected Site.

Identify Study Users (LabVantage Users) that are assigned particular access capabilities to the Documents in the Study. These capabilities include document viewing, editing, approval and management. The User Document Access tab is used to manage these Users and their document capabilities:

Defined in the BioBanking Policy are a series of rules that specify the minimum information required for a Sample before it can be used in the laboratory. This policy definition is used as the default rules for Sample approval in each Study, but can also be modified to suit the specific requirements of a Study. This editing is done in the Approval Rules tab:

Add or remove Approval Rules and specify at which approval level (Full or Conditional Approval) each is required to approve the Sample.

Once a Sample is Approved it can be used and processed in the laboratory. Aliquots and Derivatives can be created, and the Sample can be shipped to different locations.

The only difference between Conditional Approved and Full Approved Samples is that Conditional Approved Samples are indicated by an icon in the Sample list pages to tell the User that further information is still required for the Sample before it can be fully Approved.

All of the required data values can be entered during Accessioning Data Entry, submission and processing of Sample Collection Forms, or possibly on the TISM page during Sample receipt.

When full Protocol Studies are either not required or not available, Clinical Events still allows the definition of specific collection timepoints during the course Study, albeit as only very simple timepoint names. From the Clinical Events tab it is possible to define multiple events and provide a name for each event:

During the accessioning data entry process for Samples it is possible to select a specific collection Clinical Event for the Sample from the Study's Clinical Event list, or even provide a new user defined timepoint name (although this will not be added to the Study's Clinical Events list). This is a much simplified and flexible definition of Clinical Events than that provided in Protocol Studies.

During the course of a Study certain documents are completed by persons involved in the Study. Examples of such documents are Subject enrollment details, Subject consent information, Site material transfer agreements (MTA), details of Samples collected, etc. LabVantage has the capability to define templates of these documents as online Forms (See Forms) that can be completed to create Documents associated with particular SDIs. In the Study Maintenance page, in the Forms tab, it is possible to specify the Forms used by a particular Study:

Once a Form is added, you can specify to which SDC Documents from this Form, will be associated as well as when such Documents are created. Selecting "on Allocation/Creation" for a Sample means that when a Sample is created for this Study, a blank Document based on the appropriate Form will be generated and attached to the new Sample. Selecting "on Association of 1st Sample" for a Subject means that when the first Sample from this Study is linked to a particular Subject, a blank Document based on the appropriate Form will be generated and attached to the Subject. Subsequent links of Samples to the same Subject for this Study will not generate new Documents, whereas Samples linked to the same Subject for a different Study will generate new Documents as the when rule is Study specific. Any blank Documents can then be completed by the user and saved. Documents can also be created "on Demand" by the user from from the Documents tab of various maintenance pages (the Forms lookup when the "Add" button is clicked is filtered by the list provided here as well as the relevant SDC), or from the Documents management page. When automatically creating blank Documents, if the Version field is left blank, then the latest active version of the specified Form will be used, otherwise any version of the specified Form can be used when created on demand.

If the SDC field is left blank, then this indicates that the Form is to be made available within the context of the Study Documents management page, accessed from the "Manage Documents" button on the Study List or Maintenance pages. This allows the definition of a short list of Forms specific to the Study.

Biobanking Services represent any action, process or testing that needs to be done to a biospecimen. Use Services to define Laboratory operations that may be performed on incoming samples.

When a Sample is created for a particular Study, these Services are automatically applied to the Samples as defined in the Services tab. These Services are not only applied to initially collected Samples but are also applied to child derivative Samples created for the Study.

Protocol Studies

When adding Services to Protocol Studies, in addition to the Services defined here, you can define Services within the Protocol, for each collected biospecimen individually. The Services are only applied to collected Samples for that Protocol. Specify a Sample Type so that only Samples created of that Sample Type will have the specified Service applied. See Services for detailed information about defining a Service.

Consent Questions allows Biobanking to determine consent, granted or denied, by Study Participants regarding the current and future use of donated Samples. Consent Questions can be defined at the following levels:

Non-Protocol Studies

When defining Non-Protocol Studies, the Consent Questions tab displays in the detail tabs of the Study.

Click "Add" to add new questions.

Require Reconsent

The Require Reconsent button adds the new or modified question to any Participant records containing this question (who are Enrolled this Study). Whenever an existing question requires Reconsent or a new question is added, all the exisiting Participants consent records need to be updated. Select the relevant questions and click "Require Reconsent". A dialog displays confirming the update.

The status of any previously answered questions for the associated Participants are set to "Pending". The status of new questions are also set to "Pending". The over all Consent status is updated as well.

Protocol Studies

When defining Protocol Studies Consent Questions are defined in the Protocol Revision.

Click "Add" to add new questions.

Answering Consent Questions

Consent Questions are answered from the Subject or Participant List, or Maintenance pages. See Enter Consent for more information.

Viewing Consent Questions Outside of the Study

Throughout Sample Management you have the opportunity to review answers to Consent Questions associated with a Subject Sample. In the various Sample list pages a column identifies the Consent Status of the Sample. Icons provide a visual cue as to the availability of the Samples. Consent is Granted or Restricted. Consent is Pending until all questions are answered. If at any point a question is answered negatively (even if all questions have not yet been answered) Consent is Restricted.

Clicking the icon opens the Participant Consent dialog.

Here you can view the answers to the specific questions asked, and determine whether or not the Restriction applies to your need.

As questions are added or changed on a Study, and a Reconsent is requested, the Subject is updated to include the changes. All previous versions of the Consent Questions display.

Study Maintenance	Top

Once a Study is added its Status determines on which List page it appears. From the List Pages you can perform additional functions or maintenance.

Study functionality is distributed across multiple Study List pages, accessed from the LIMS → BioBanking menu and based on the state of the Studies as described below:

Following is a description of each operation:

Study Approval	Top

In order for Approvals to be completed, the Study must first be "Submitted for Approval" from the Study Maintenance page. Once submitted for approval the Study is no longer available for editing from the New Studies list page, but must be accessed from the Studies for Approval list page for review and approval. Upon review of a Study it can be approved or rejected using the Approvals dialog and a subsequent e-signature:

When a Study is approved it is then made active and accessible from the Active Studies list page. If a Study is rejected it returns to an editable state and is accessible from the New Studies list page.

If a Study is created from a template that does not contain any Approval Types, then the Study is immediately marked as Active and accessible from the Active Studies list page. Such Studies are not submitted for approval and bypass any approval step.

Generate Kits	Top

From both the Study list and maintenance pages it is possible to create the Kits required for the Study. This is available for both protocol and non-protocol Studies.

The "Generate Kits" button, on the Study list and maintenance pages, opens a Kit Type lookup page to select the type of Kits to generate. By default this lookup displays the Kit Types used for the different events defined in a protocol Study, but the search bar and queries can be used to list other Kit Types.

From the Kit Type lookup page it is possible to create a new Kit Lot containing the specified number of Kits. Kits generated in this way are associated directly with the Study and the Kit Ids typically contain the Study Code. Using the "Generate Kits" button, on the Kit Type lookup page, you will be prompted for the number of Kits to generate and then be shown a Kit Lot Maintenance page:

On this page further details of the Kit Lot can be entered and saved. Once the Kit Lot is created, pressing the "Create Shipment" button will initiate a Package containing the selected Kits that can then be shipped to any of the Sites defined for the Study: