NIDDK Definitions

A request for specimens by a researcher who is collaborating with the network or a study investigator from which the specimens originated. Associated data for an ancillary study are provided by the study’s coordinating center.

A study that uses data, specimens, or other resources generated by an actively funded parent study, collects new data, or derives data for purposes that are separate from or beyond the original scope of the parent study.

The Authorized Organization Representative (AOR) is the individual, named by the Requesting Institution, who is authorized to act for Requestor and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards. The AOR is also referred to as the authorized signatory or Signing Official (SO). Please see the NIH Grants Glossary page for additional details. The authorized person fulfilling this role may have any number of titles in your organization (e.g., a Manager, Officer, Director, Vice President, or Chief of contracts, grants, licensing, research administration, or sponsored programs for the institution). Note: If registered with eRA Commons (not required), requestors should use the same authorized person (e.g., Grants Management Specialist) as listed in eRA Commons.

Data and specimens under the guardianship of NIDDK Central Repository that are available for request by the broader scientific community.

Organization contracted by NIDDK to receive, store, and manage biological specimens from NIDDK-sponsored studies.

A crosslink provided by the study’s coordinating center (or investigator) used to link (match) each specimen to a unique participant-visit.

Represents a group of investigators, oftentimes funded via a cooperative agreement, from multiple institutions who have agreed to participate in cooperative research efforts to address a common research objective. Please see “Network” definition for additional details.

An NIDDK-sponsored network, consortia, or study group that deposits resources generated by the conduct of clinical study protocol(s) into NIDDK Central Repository. Contributing Study is sometimes referred to as a parent study.

Organization or entity responsible for a study’s data management, monitoring, and analyses. Common names for these coordinating units include Data Coordinating Center (DCC), Biostatistics and Data Management Center/Core (BDMC), and Statistical Data Management Center (SDMC).

The act of organizing, formatting, editing, and compiling study data and associated documentation.

A legally binding agreement between NIDDK and the requesting institution that sets the terms and conditions to use Resources provided by the NIDDK Central Repository for secondary or confirmatory research.

Study data and associated documentation that are transferred from a study’s coordinating center to NIDDK Central Repository for secondary research use. Data packages should include at a minimum the study data, protocol, variable codebook/data dictionary, manual of operations, and other documentation related to the data collection or configuration of the study.

The process of verifying that the data transferred from a contributing study are complete and valid; the DSIC is performed by replicating select tables from publications based on the study data. The DSIC is performed by a Statistical Data Specialist.

The database of Genotypes and Phenotypes (dbGaP) that was developed by the National Center for Biotechnology Information (NCBI) to archive and distribute the results of studies that have carried out high density genotyping.

A DOI is a unique and permanent reference tied to the metadata about the digital object and is assigned to online resources, such as NIDDK-CR studies, to increase findability, accessibility, and reusability. Users should include the resource’s unique identifier, DOI, when citing use of NIDDK resources in publications and other research outputs.

A two-step process to request specimens and associated data stored under the guardianship of NIDDK Central Repository and which are available for request by the broader scientific community. External specimen requests begin with an “Availability Inquiry” to determine if the volume and quantity of specimens meeting desired research criteria are available and in sufficient volumes/quantities. Please see “Impact Report” definition for additional details. Based on the information contained in the “Impact Report,” requestors may gain access to the specimens by submitting an “Access Request.” Access Requests require the provision of a research plan, proof of funding, and other documentation, as applicable, for NIDDK review and approval prior to the specimens being processed and shipped.

A page on NIDDK Central Repository website that provides answers to frequently asked questions about the submission and request of resources.

Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, 45 CFR Parts 160, 162, and 164. Part 160.103 of the HIPAA law regulates individually identifiable health information that is related to a person’s past, present, or future health or treatment and is transmitted or maintained in any form or medium by a covered entity.

A report that provides an estimate of the available specimens and the impact a request would have on the remaining specimen collection based on a requestor’s requested study(ies), number of specimens, specimen type(s), amount of material (e.g., volume, mass), timepoint(s)/visit(s), and participant criteria. This report is generated during an Availability Inquiry as the first step of an external specimen request. The impact report can (and should) be included with a grant application that would support the use of the specimens.

A request for specimens by a researcher who is part of the actively funded network or study from which the specimens originated for purposes that are within the scope of the primary study aims.

A dataset from which direct personal identifiers have been excluded, but which may contain indirect personal identifiers. A DUA accompanies their distribution by the NIDDK Central Repository and stipulates the permitted uses and disclosures that can be made by the recipient of the data. The requirements for a limited data set are specified in the HIPAA regulations in 45 CFR Part 164.514 (e)(1)-(4).

A substitute unique participant identifier to replace an existing participant identifier used during the study conduct for additional confidentiality protection.

An agreement and attestation between NIDDK and the contributing study representative, such as the study’s coordinating center, to accept and distribute data and specimens at NIDDK Central Repository.

A term used to define items submitted to NIDDK Central Repository including but not limited to all data, specimens, products, analytes, metadata, documentation, code, analytic tools, methods, algorithms, workflows, results, summaries, analyses, or conclusions generated by a contributing study or directly resulting from the use of NIH/NIDDK provided Resources.

May represent a single study or a collection of studies conducted by a group of investigators from different institutions collaborating to address a common set of diseases or research objectives. Please see "Consortium” definition for additional details.

A component of NIDDK Central Repository (NIDDK-CR), outsourced under federal contract to receive, store, and manage biological specimens on behalf of NIDDK-CR.

A component of NIDDK Central Repository (NIDDK-CR), outsourced under federal contract to receive, archive, manage, and distribute study generated resources on behalf of NIDDK-CR. The Data Repository serves as the coordinating unit for NIDDK-CR.

NIDDK-sponsored clinical research studies that are currently collecting data and/or specimens.

A random alpha-numeric character generated as a means of connecting study participant records using a secure pseudonymization processes in a data set that refers to the same study participant across different data sources. PPRL, also known as Global Unique Identifier (GUID), maintains participant privacy, allowing researchers to aggregate and share a participant’s data without exposing personally identifiable information (PII).

Individually identifiable health information that is related to a person’s past, present, or future health or treatment and is transmitted or maintained in any form or medium by a covered entity. NIDDK Central Repository is not a covered entity serving as honest broker between covered entities (submitting and requesting organizations). PHI is defined in the HIPAA regulations in 45 CFR Part 160.103.

Report of findings of a study, protocol, or research project that is made public through inclusion in a recognized print or online outlet.

A written protocol-level onboarding request that aligns with NIH Data Management and Sharing (DMS) Policy and NIDDK DMS Guidance describing timelines for submitting and for publicly sharing the resources generated in the conduct of the study protocol in accordance with the NIDDK Central Repository Archival and Sharing Policy submission and sharing schedules.

A page on NIDDK Central Repository (NIDDK-CR) Resources for Research (R4R) website that a user fills out to apply to receive data and/or specimens and to provide information on the planned use and need for the resources. The web-based workflow system is used for communication between the requestor and the contracted repository support team, NIDDK’s review and management of the requests, and processing of approved requests for delivery to the requestor.

A term used to define items provided by NIDDK Central Repository including but not limited to data, specimens, products, analytes, metadata, documentation, code, methods, analytic tools, algorithms, workflows, results, summaries, analyses, or conclusions generated by a contributing study.

Data files containing specimen-level data from participants in a contributing study which can be downloaded by the originating study team for the purpose of reconciliation with internal data or documentation.

In the context of NIDDK Central Repository (NIDDK-CR), a study within the mission of NIDDK that has or will submit study-generated resources to NIDDK-CR, that is guided by a unique protocol which can include an additional protocol, referred to as a Sub-Study.

Unique combination of letters and/or numbers that identifies each study site that contributes resources to NIDDK Central Repository.

An additional protocol within a study, excluding ancillary or continuation protocols, undertaken to address an aim that may or may not be within the scope of the primary study aims.