BIGR® Biospecimen and Biobanking Software Modules

The Registration module enables efficient barcoding and entry of samples, donors and collection events. Sample barcodes can be generated and printed on demand or pre-generated and pre-printed. Donor deidentification is supported through system-generated identifiers, associated with IRB-approved protocols and informed consent interviews, and donors can be tracked through collection events including diagnostic and surgical procedures. Registration Forms, using the same KnowledgeCapture™ technology that powers the Data Annotation module, can be associated with donors, collection events and samples to allow data collection at the time of registration. Customizable rules dictate the sample types that are available, assignment of samples to Inventory Groups, and the appropriate Registration Form for each sample, based on its sample type and the IRB protocol under which it is collected.  See our behind-the-scenes look at registering a sample in BIGR® to learn more.

The Label Printing module allows labels to be completely customized to contain 1D, 2D and Data Matrix barcodes along with the values of any set of data elements captured by a Registration Form or Annotation Form. Labels can be either preprinted or printed on demand to support any sample registration process, and labels can be reprinted if necessary. BIGR® integrates with the industry leading BarTender® label software to support an unlimited number of label templates along with an unlimited number of label printers.

Inventory Groups provide a way to partition your sample inventory, allowing access to individual samples to be restricted to those users authorized to access an Inventory Group containing the sample. Inventory Groups can also be used to permit samples to be reserved for any purpose.

The Sample Derivative Operations module enables the user to subdivide, aliquot, pool, and perform other derivative processes, while maintaining sample genealogy. Batch mode allows multiple derivative operations to be recorded at the same time, and allows for efficient specification of data values. Customizable rules allow specification of valid derivative sample types, data inheritance and default values. The volume or weight of parent samples is adjusted automatically and the parent is marked consumed if appropriate, in a fashion that allows the user to override the system if desired. Integration with the Label Printing module allows labels for all derivatives to be printed on demand at the time they are created in the system.  See our behind-the-scenes look at derivative operations in BIGR® to learn more.

The Data Annotation module provides tools for designing and deploying configurable and evolvable Data Annotation Forms, which can be used to extensively annotate samples and donors. These forms can be constructed from a pre-built library of over 3000 structured data elements organized by disease relevance and built around standards such as SNOMED-CT, CAP Synoptic Reports, AJCC6, HUGO and LOINC. New biomedical content is easily incorporated into the data annotation library, enabling the rapid deployment of new or updated Data Annotation Forms. All data elements in the library can be queried using the Sample Search and Request module, enabling a complete solution for data capture and querying. The Data Annotation module is powered by KnowledgeCapture™, which was developed under a research grant from the U.S. National Institute of Standards and Technology Advanced Technology Program. For more on this technology, see our Overview of KnowledgeCapture™.  Also see our behind-the-scenes look at a data annotation form to learn more.

The Sample Search and Request module, designed by scientists and researchers from diverse disciplines, is a powerful query tool used to locate, evaluate and compare samples. Search criteria can include any data element captured in BIGR®, including elements from Registration Forms and Data Annotation Forms. The tabular results format, which can be customized by each user to also include any data element captured in BIGR®, allows for quick inspection and comparison of results. Drilldown pages are accessible for each sample to allow all relevant Registration Forms and Data Annotation Forms to be viewed, and a configurable URL linking mechanism allows visual integration with any web-based system on a per sample basis. Once samples of interest are identified a request can be made to deliver them to a researcher’s lab, whether that lab is local to the biorepository or remote.  See our behind-the-scenes look at a sample query page and a sample results page to learn more.

The Request Management module provides for comprehensive management and fulfillment of requests. A repository manager can view open requests along with all request details, and either accept and fulfill or reject the request. Email alerts keep both the requestor and repository manager informed of the creation and progress of a request. A sortable picklist can be displayed and printed to allow the repository manager to locate samples in inventory in an optimal manner. A wizard-like interface guides the repository manager through the request fulfillment process, performing numerous validations to ensure each request is fulfilled accurately. Integration with the Inventory and Logistics module enables a request to be shipped to a remote location if necessary.

The Inventory and Logistics module supports the biospecimen banking and distribution process. Samples may be added to inventory immediately to preserve their quality by simply scanning their barcode, or they may be registered first through the Registration module. Multiple storage types and container layouts are supported, and system validations ensure that samples are stored in appropriate storage units. The status and location of each individual sample is precisely tracked. Sophisticated inventory management suggests a suitable location for newly introduced samples, allows a user to override locations suggested by the system, and allows relocation and consolidation of samples for optimal utilization of storage units. Shipping and receiving functions allow requested samples to be shipped from a biorepository to a requesting institution, with each step in the process tracked by the system.

The Inventory Control Panel (ICP), based on the Audit History module, records and displays the audit history of BIGR® elements including samples, donors, collection events, requests, manifests, boxes, and Inventory Groups. All BIGR® transactions that change the state of the system are recorded in the audit history and are viewable through ICP. A high degree of hyperlinking within ICP allows the user to quickly navigate among related elements, and this hyperlinking extends to other appropriate BIGR® modules to allow easy entry into ICP for appropriately privileged users. This provides the research/study coordinator, repository manager, researcher, and laboratory technician valuable context and history, including a chain-of-custody report with specific details on each of the tracked activities. See our behind-the-scenes look at ICP to learn more about how ICP allows audit history to be viewed.

The System Administration module supports general administration and configuration of the system through the same web-based interface used by all BIGR® users. A system administrator can create and manage users and their privileges, indicate which sample types are to be collected, define new IRB protocols and consents, design Registration Forms and Data Annotation Forms and specify the contexts for their use, create and manage Inventory Groups, and set up storage units and box layouts.

The Reporting module comprises a set of read-only database views that enable a wide range of reporting options. Virtually any reporting client, including Crystal Reports, BusinessObjects and even Microsoft Access can be used to connect to the reporting views and create a wide variety of reports.

Regarding Security, BIGR® incorporates a variety of measures to control access to the system and fulfill regulatory guidelines, including individual user accounts, recording of unauthorized login attempts, locking user accounts after an administrator-defined number of failed login attempts, password expiration after an administrator-defined number of days, strong passwords consisting of a combination of numbers and letters, a forgotten password question, an explicit logoff mechanism and expiration of a user’s session with automatic logoff after an administrator defined period of inactivity. Inventory Groups allow only authorized users to access samples and their data. The Audit History module provides a full audit trail to meet regulatory guidelines.

To meet Integration needs, BIGR® provides a suite of Application Programming Interfaces (APIs) to enable access to and modification of data annotations. These APIs are designed to fit within application architectures in common usage. BIGR® can also interoperate with any third party system with published integration interfaces. For one such example, see our behind-the-scenes look at BIGR®’s integration with the Aperio digital pathology system.