Glossary

Coordinating center that manages the operational activities of the Aeras Biorepository. It also provides a single web-based user interface to give interested researchers an access point to resources.

A process wherein a specimen is divided into separate parts which are typically stored in separate containers as individual samples. The term aliquot may also be used as a noun to denote a single sample (ISBER 2008 Best Practices for Repositories)

An additional or secondary trial that was not part of the original study design.

Anonymized data and samples are initially single or double coded but the link between the subjects' identifiers and the unique code(s) is subsequently deleted. Once the link has been deleted, it is no longer possible to trace the data and samples back to individual subjects through the coding key(s). Anonymization is intended to prevent subject re-identification. (Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. FDA April 2008).

All individuals specifically identified in the Research Plan, including the PI. Only individuals listed in the Research Plan may have access to the Research Materials.

Someone in a senior position who is authorized to commit to procurements or the allocation of resources. The particular titles vary widely between institutions.

A computer system used to manage and maintain biospecimen inventories (Also see Biorepository informatics system)

Standard operating procedures that are considered state-of-the-science consistent with all applicable ethical, legal, and policy statutes, regulations, and guidelines. (NCI Best Practices working definition)

An organization, place, room, or container (physical entity) where biospecimens are stored. In the context of the NCI Best Practices, only biorepositories containing human specimens collected with an intention to use them for research purposes (research biorepositories) are addressed. The physical structure, policies, and the biospecimens and data contained within it are defined collectively as a biospecimen resource, defined below (NCI Best Practices working definition).

The software, hardware, written documents, support, and training that are necessary to annotate, track, and distribute biospecimens within a biorepository or biorepositories.

A quantity of tissue, blood, urine, or other biologically derived material. Portions or aliquots of a biospecimen are referred to as samples (NCI Best Practices working definition).

A collection of human biological specimens and associated data for research purposes, the physical entity where the collection is stored, and all relevant processes and policies. Biospecimen resources vary considerably, ranging from formal organizations to informal collections of materials in an individual researcher's freezer (NCI Best Practices working definition).

Factual information (as measurements or statistics) or observations used as a basis for reasoning, discussion, or calculation pertaining to clinical trials, diagnosis, or treatment (NCI Best Practices working definition).

Patient-oriented research, including epidemiologic and behavioral studies, outcomes research, and health services research. Patient-oriented research is research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) in which a researcher directly interacts with human subjects. It includes research on mechanisms of human disease, therapeutic interventions, clinical trials, and development of new technologies, but does not include in vitro studies using human tissues not linked to a living individual. Studies falling under 45 CFR 46.101(a) (4) are not considered clinical research for purposes of this definition. (NIH grants glossary, http://grants.nih.gov/grants/glossary.htm#ClinicalResearch)

The clinical study under which Research Material was collected.

A biomedical or behavioral research study of human subjects designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. (NIH grants glossary, http://grants.nih.gov/grants/glossary.htm#ClinicalTrial)

The codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the US Federal Government. (GPO Access, http://www.ecfr.gov). The Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. (GPO Access, http://www.ecfr.gov)

Means that (1) identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens. (Office for Human Research Protections, Guidance on Research Involving Coded Private Information or Biological Specimens, http://www.hhs.gov/ohrp/regulations-and-policy/guidance/research-involving-coded-private-information/) Coded biospecimens are labeled with at least one specific code and do not carry personal identifiers.

1. Single-coded biospecimens. Biospecimens are labeled with a single code and do not carry any personal information. It is possible to trace the biospecimens back to a given individual.
2. Double-coded. Biospecimens are initially labeled with a single specific code and do not carry any personal identifiers. They are then relabeled with a second code, which is linked to the first code via a second coding key. It is possible to trace the biospecimens back to an individual by use of both coding keys.

(Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. FDA April 2008).

The caretaking responsibility for a biospecimen collection, including management and documentation, as well as rights to determine the conditions under which the specimens are accessed and used. (NCI Best Practices working definition)

Factual information derived from scientific experiments or diagnostic procedures organized especially for scientific analysis in a numerical form suitable for digital transmission or processing by computer, digitally transmitted or processed and used as a basis for reasoning, discussion, or calculation. (NCI Best Practices working definition)

A data file or a collection of interrelated data records (also see Study Data Set)

Systematic destruction of medical waste and other biohazardous waste. (NCI Best Practices working definition)

A process that includes receipt of request for specimens, selection of appropriate specimens, and final inspection, in conjunction with subsequent shipment and delivery of specimens to another repository, specimen collection center, or laboratory. (ISBER 2008 Best Practices for Repositories).

A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. (45 CFR 46.102(f))

The legally effective consent of the human subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent. Whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence (45 CFR 46.116(a)).

Any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of the research and conduct periodic review of such research. (ISBER 2008 Best Practices for Repositories)

Any written, printed or graphic material on or affixed to a specimen container or package (ISBER 2008 Best Practices for Repositories)

A list that associates biological samples with the relevant clinical data. It is used to match the IDs that were used for the biospecimens to those that were used for the clinical records for all of the study subjects.

Generally is utilized when any proprietary material is exchanged, and when the receiving party intends to use it for his/her own research purposes. Neither rights in intellectual property nor rights for commercial purposes may be granted under this type of agreement. (NIH Office of Technology Transfer)

1. The clinical study collecting the data and/or biospecimens. 2. The principal or primary study (see ancillary study).

In the context of the biorespository, an individual judged by the Recipient to have the appropriate level of authority and responsibility to lead the scientific investigation proposed in the Research Plan using the Research Materials, oversee the supporting staff who are provided access to the Research Materials and contribute to the analytic effort and public disclosure of STUDY results, and assume responsibility for all team members' compliance with the terms and conditions of the MTA.

An individual judged by the Recipient to have the appropriate level of authority and responsibility to lead the scientific investigation proposed in the Research Plan using the Research Materials, oversee the supporting staff who are provided access to the Research Materials and contribute to the analytic effort and public disclosure of Study UDY results, and assume responsibility for all team members' compliance with the terms and conditions of the MTA.

Any procedure employed after specimen collection but prior to its distribution, including preparation, testing, and releasing the specimen to inventory and labeling. (ISBER 2008 Best Practices for Repositories)

Individually identifiable information transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium. (45 CFR 160.103) (See HHS Office for Civil Rights HIPAA, http://www.hhs.gov/ocr/hipaa/)

In the context of the biorepository and person or organization that is seeking access to the Study Research Materials.

An entity that receives, stores, processes and/or disseminates specimens, as needed. It encompasses the physical location as well as the full range of activities associated with its operation. It may also be referred to as a biorepository (ISBER 2008 Best Practices for Repositories)

Systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)).

The requested materials covered by the MTA and may include Clinical Study data, defined as clinical or epidemiologic subject data, and/or Clinical Study biospecimens. Study biospecimens may have associated characterization data. Characterization data serve to describe Study biospecimens only and are not considered to be Clinical Study data.

A description of the proposed research that includes the identities of the investigators participating in the research effort. The Research Plan must include the project title, the RECIPIENT's name, the PI's name, the name of other APPROVED USERS, and the proposed research protocol with the research objectives and design. For plans including biospecimens, the biospecimen material type, number, minimum volume, and required characteristics needed to meet the objectives of the protocol must also be included.

The removal, acquisition, recovery, harvesting, or collection of specimens (ISBER 2005).

1. Portions of biospecimens (NCI Best Practices working definition). 2. A single unit containing material derived from one specimen (ISBER 2008 Best Practices for Repositories).

See Biospecimen

The quantitative or qualitative information linked to the biospecimen which may include: type of specimen (i.e. plasma, urine), type of fixative or additives, some demographic data, and laboratory test results.

Established or prescribed methods to be followed routinely for the performance of designated operations or in designated situations (Merriam-Webster Dictionary)

The accumulated biospecimens collected by a clinical study. (NHLBI working definition)

The information collected and recorded from study participants through periodic examinations and follow-up contacts, not including original specimens or images.

The research investigator who conducted the Clinical Study.

An aggregate of cells with different specialized characteristics that are organized anatomically, usually in the fixed framework of an organic matrix. The architectural organization that is maintained contributes to the performance of the specific collective function. Tissues are parts of organs. The term tissue is most often referred to in the context of solid tissue, as originating from a solid organ; however, tissue also can be defined broadly to include collections of cells and the extracellular matrix and/or intercellular substances from bodily fluids such as blood (NCI Best Practices working definition).