Laboratory Concepts: BioBanking

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Fundamental Concepts

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Study Setup

Laboratory Concept

LabVantage Concept

Example

Design Study

A Study is a research project undertaken to assess the safety, efficacy and outcomes of a drug, regimen or procedure.

The definition of the Study includes information on:

•	Type of study such as clinical, observation, discovery etc.
•	Study contacts or individuals who can be contacted about a Study
•	Expected number of participants
•	Tests/Procedures to be carried out
•	Sample collection events
•	Approvals required before study can be initiated
•	Sample Approval Rules to specify the minimum information required for a Sample before it can be used in the laboratory.

I have designed a Study Protocol to determine the effectiveness of "Product A", at different dosing levels, in reducing Cholesterol in patients over 50. Study Participants can be male or female, over the age of 50 from various locations. At the initial visit "Product A" will be dispensed to all participants and an initial blood Sample taken. Randomly patients will receive 100 mg or 200 mg of "Product A". Participants are instructed to take "Product A" daily for 12 months. Blood Samples will be collected each Month until Study completion.

To set up the study I define the following within LabVantage:

Setup		Description
Site	BMA100 ANY100	Two collection Sites are defined.
Study Contacts	Susan Dave Mary	Susan is an external Contact coordinating the Study in Boston. Dave is an external contact coordinating the Study in New York. Mary is the LabVantage User responsible for managing the Study.
Study Type	Discovery	Samples will be collected from various locations based on a defined Protocol.
Consent Questions	For Testing	Use Sample for Testing.
	For Storage	Store Sample for 10 years.
Approvals	StudyAp1	The Approval rules state that in order for the Study to become Active the condition "No Approvals have Failed" must be met. "StudyAp1" also identifies John as the User assigned to Approve the study.
Events	Visit 1	Enroll Participants, dispense "Product A" and Collect initial Blood Sample. Perform test "LP1" to evaluate initial cholesterol levels.
	Collection	Collect Blood Sample monthly and perform test "LP1" to evaluate current cholesterol levels.
Protocol Revision 1	Cohort 1 Dose: 100 mg Product A	Events: Visit 1 Collection	Collection Plan: Collect Blood Sample in a Blue Vac Tube-4mlContainer and apply Test LP1
	Cohort 2 Dose: 200 mg Product A	Events: Visit 1 Collection	Collection Plan: Collect Blood Sample in a Purple Vac Tube-4mlContainer and apply Test LP1

The Study is defined and ready for Approval by John.

Enumerate Study Sites

Sites identify the location(s) from which Samples are collected for a particular Study such as hospitals or universities.

Describe Study Protocol

A Protocol describes, in detail, a plan for conducting a Study. The Protocol explains the purpose and function of the Study as well as how to carry it out.

A Protocol specifies a series of Specimen Collection Events. For each event, it is possible to define the Specimen Collection Plan that includes different types of Samples to collect , the containers in which the Samples are collected and any test to apply to the Samples. Each event can also be assigned to a specific Cohort in the Study. Event types allow the definition of Enrollment, Collection, Withdrawal and Completion events. Some events might require Documents to be filled out by the Participant or the appropriate Study Coordinator. The type of Collection Kits required for a specific event can also be defined.

Determine Cohorts

A Cohort is a group of individual enrolled in a Study according to specific criteria or having different dosing regimens.

Define Specimen Collection Events

Visit/Time point represents a specimen collection event associated with the protocol.

Determine the Specimen Collection Plan

A Collection Plan details the plan for collecting and testing Samples for each event. The plan identifies the different Types of Samples to collect and defines which Tests to apply to each Type.

The collection plan also specifies the container in which the specimen is collected.

Specify Specimen Collection Kit

Kits intended for the collection of samples can be specified for every event.

Often Kits are shipped out to various collection sites. The sites then collect the necessary Samples and send the Kit items back for processing and storage.

Specify how Specimens are Processed and Stored

Service specifies the procedure for processing, storing & shipping samples collected for a study.

Service can be used to:

•	Execute a test against a specified sample or against a child sample of the specified sample.
•	Create a child sample of the specified sample.
•	Indicate to store or ship a specified sample or a child sample of the specified sample.

A Child Sample Plan lets you predefine a plan for specimen processing by creating multiple Aliquots and Derivatives from new or existing Samples. It determines how many child Samples (Aliquots or Derivatives) to create and in what quantities.

Create Consent Questions

Study-specific, protocol-specific and cohort-specific Consent Questions can be defined for a Study or for a Protocol.

Specify Tests to be Performed

A Test provides a set of instructions for conducting an analytical test including any number of Parameter Lists. Adding Tests to a Study allows laboratory testing results to be recorded against the collected samples.

Specify forms to gather demographic information

Document resemble traditional paper forms and may be used to collect information about the specimen and its donor.

A Study User (LabVantage user) is someone who is granted access to a Document. Study Users are assigned particular access capabilities to the Documents in the Study. These capabilities include document viewing, editing, approval and management.

General BioBanking

Laboratory Concept

LabVantage Concept

Example

Use Controlled Vocabulary

Standard code sets such SNOMED, ICD-9, ICD-10 and local data dictionaries can be imported into LabVantage master data objects.

Enroll Participants into a Study

Subject represents an individual who participates in a study. Associated with a "Subject" is all the information obtained about the individual such as species, gender, age or medical history.

Participant is a subject enrolled into a study at a study site.

John Approved the Study and it is now an Active Study.

At the initial visits information is collected from each individual willing to participate in the study. This information is added in LabVantage as a Subject. Each subject found eligible to participate in the Study is then Enrolled as a Participant.

Gather Consents from Participants

As Participants enroll in the Study, the answers to the Consent Questions defined for a protocol can be gathered by the Study Coordinator.

As the questions on a Protocol Revision or Study change, Participants may be asked to Re-consent to all or part of the new questions.

Donors are asked to answer yes or no to the following consent questions:

I permit my Samples to be used for performing blood tests.

I permit by Samples to be stored for 10 years.

Generate Labels for Tubes

During Allocation, a sample ID can be created, printed onto a bar code, and the barcode can be shipped to a collecting facility.

Receive Specimens

Samples can be marked as Received to indicate that the physical samples are Received by the Biobank.

100 Samples are Allocated for this Study. 100 labels are printed, 50 are sent to the collection site "BMA100" and 50 to "ANY100".

As Samples are collected at each Site the labels are placed on the containers. The containers are packaged and shipped back to the Laboratory.

Upon receipt of the package the laboratory "unpacks" the package and the Samples are "Received" in LabVantage.

Annotate Specimens

Accessioning is the process of annotating samples with phenotypic information such as type of sample, the age and the disease state of the person the sample was taken from. Accessioning Data Entry is where you enter details about the Sample such as its donor, collection Site and collection details.

Some Studies may require that another party perform additional Verification or authorization on a Sample prior to its release to circulation. This request can be made during Accessioning.

Accessioning is the process of associating a received Sample with a Subject (or donor, and all associated information). Either search for, and directly associate, the Sample with an existing Subject or create a new Subject based on the attributes provided with the Sample. Accessioning Data Entry is where you enter details about the Sample such as its donor, collection Site and collection details.

Some Studies may require that another party perform additional Verification or authorization on a Sample prior to its release to circulation. This request can be made during Accessioning.

After the Samples are "Received" they are ready to be Accessioned. Since Subjects were created during Sample collection Mary can lookup the Subject and associate it with the Sample. The information collected about the donor, collection site, and collection details are entered.

Mary enters the following information for Sample "SS-001":

Setup	Description
Subject	SS-00023
Collection Site	BMA100
Gender	Male
Age	55
Consent Question 1	Yes
Consent Question 2	No

Process Specimen to create Aliquot, Derivative or Pooled Samples

When necessary Aliquot and/or Derivative Samples can be created from one or more parent Sample(s). Any Preparation or Treatments needed for Derivatives can be defined. Optionally, Aliquots or Derivatives can be associated with a Study different from its Parent�s Study.

Pool Samples allows you to select any number of Samples (of the same Sample Type) and pool them together to create a new Sample.

Aliquot and Derivatives are not necessary.

Perform Analysis on Specimen

When the Sample is Received, Accessioning is complete, and the Sample is Approved (if required), the Sample becomes available for testing. Using Results Data Entry record results for tests defined in the Study.

Once Accessioning is complete the Samples are ready for testing. Mary performs the test "LP1" and enters the results. The results are approved by John and the Sample is disposed. Consent was not given to store the Sample.

Store and Track Specimen

Advanced Storage and Logistics (ASL) provides centralized material tracking and includes the following capabilities:

•	Detailed location & shipment tracking
•	Aliquot, derivative & pooled sample tracking
•	Electronic signature capture on transfer & disposition of samples
•	Complete history of sample transfers, custodian and location changes
•	Freeze-Thaw cycle count

When the Samples were received they were placed into a specified Storage Location until needed. At that time a Trackable item was created and associated with the Sample to ensure the Sample location is known at all times.

In this example Chain of Custody is required. Freeze Thaw tracking is not required.

Retrieve Specimen from Storage

Check Out removes a Sample from Storage and puts the Sample in the User's personal custody.

Handle External Request to Ship Specimen

Request Management handles submission, review and fulfillment of samples request.

Another Laboratory is looking for 5 Samples from male subjects over 50 years old. Mary searches for Samples matching this criteria and whose consent allows the Sample to be used in another Study.

Track Chain of Custody

Chain of Custody (COC) establishes and documents ownership and location of a Sample. When performing any operation on the Sample you must conform to the Custodian's rights.

As Mary Checks Out the 5 Samples she is required to relinquish custody to a User in the receiving laboratory.

Ship and Track Specimens

Packages can be used to track incoming and outgoing shipments received from or shipped to a location inside or outside of your organization.

Mary creates a package for the 5 Samples. She specifies the destination location, herself as the sender, and enters details about the shipment. Using the TISM page she moves the Samples from their current location into the package.