Technical and Operational Best Practices

Driven by the scale of data in genomics and proteomics, informatics systems have become critical to the research enterprise. A minimum set of functional, operational, and legal requirements should be considered best practices (as outlined in this document) and should be incorporated when developing or selecting informatics systems to support biospecimen resources. These informatics systems should be robust and operationally reliable to sustain day-to-day operations of a biospecimen resource and offer the key requirements needed by those using the biospecimen resource. Informatics systems should be able to adapt and meet changing scientific needs. These needs may include ensuring the system can track new processing methods, new biospecimen protocols, new equipment technology, or new container types.

An informatics system should support all aspects of biospecimen resource operations, including, but not limited to, tracking of research participant enrollment and consent; biospecimen collection, processing, storage, and dissemination; QA/QC processes and documentation; collection of or electronic linkage to research participant (i.e., clinical) data; data security; and management reporting functions (e.g., generating reports on inventory, collection, utilization, QA, etc.) . In addition, the system should store a minimum, common set of clinical data.

Biospecimen resource informatics systems are a key tool in providing accountability of biospecimens (e.g., location) and related data uses to research participants. Biospecimen resources should implement and operate their informatics systems with security mechanisms such that this accountability demand is met (see Section B.6.7, Regulatory Issues Pertaining to Informatics Systems, and Section C.1, Principles for Responsible Custodianship) .

In addition, the informatics systems should ensure interoperability of systems (i.e., other biospecimen resources or different data systems) because this is key to exchanging data and biospecimens. This should include integrating with other systems where genomic, proteomic, radiology imaging, pathology imaging, and other relevant data are captured or shared.

To address this need, the NCI Center for Bioinformatics developed caBIG. caBIG is a voluntary network grid connecting individuals and institutions to enable the sharing of data and tools across the NCI-supported research continuum, especially for clinical and translational research. Biospecimen resources are encouraged to draw upon caBIG to implement the informatics recommendations in this section. The caBIG program and associated tools/resources enable interoperability for all aspects of cancer research and are continually evolving and growing in scope beyond cancer research. A subset of caBIG tools is available to support biospecimen management and biospecimen sharing.

B.6.1. Functionality—General

• B.6.1.1.
  At the biospecimen resource level, informatics systems should be focused on recording data types as described in Section B.5. This includes inventory functions, tracking all phases of biospecimen acquisition, processing, handling, QA/QC, and distribution from the collection site (research participant) to utilization (researcher) .
• B.6.1.2.
  The informatics system should have the capability of linking the labels on the physical biospecimen container (e.g., paper labels or barcodes) to other information regarding that biospecimen in the system.
• B.6.1.3.
  Informatics systems should track clinical data associated with a biospecimen and/or link biospecimen data with external sources of clinical data, where applicable.
• B.6.1.4.
  Biospecimen resource informatics systems should monitor and report on any recorded measures of biospecimen quality, such as RNA integrity number.
• B.6.1.5.
  Biospecimen resource informatics systems should provide vital system statistics and audit logs of all access to protected health information (PHI) in the database.