An entirely new study approved by NIDDK, collaborating with, and using data and specimens generated by an actively funded study. Ancillary studies attempt to answer questions not resolved through the parent study.
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.
Data and specimens under the guardianship of NIDDK Central Repository that are available for request by the broader scientific community.
The Authorized Organization Representative (AOR) as defined by NIH is the individual, named by the applicant organization, who is authorized to act for the applicant 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.
Organization contracted by NIDDK to receive, store, and manage biological specimens from NIDDK-sponsored studies.
A crosslink provided by the study’s coordinating center used to link (match) each biological specimen to a unique participant-visit.
Organization or entity responsible for study’s data management, monitoring, and analyses during clinical studies. 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.
Study Data and associated documentation that are transferred from a study’s coordinating center to NIDDK Central Repository for secondary research use. Data packets should include, at a minimum, the study data, protocol, variable codebook, manual of operations, and other documentation related to the data collection or configuration of the study.
Organization contracted by NIDDK to receive, archive, manage, and distribute study generated resources from NIDDK-sponsored studies.
A specific form of a Materials Transfer Agreement (MTA) between NIDDK and the requesting organization to use data provided by NIDDK Central Repository for secondary or confirmatory research.
The process of verifying that the data transferred from a study’s coordinating center 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 Genotype and Phenotype (dbGaP) that was developed by 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 resources' unique identifier, DOI, when citing use of NIDDK resources in publications and other research outputs.
A request for a study’s specimens and associated data under the guardianship of NIDDK Central Repository that are available for request by the broader scientific community, and are not being requested via collaboration with the parent study.
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 request for study specimens by a researcher who is part of the actively funded network or study from which the specimens originated.
A dataset from which direct personal identifiers have been excluded, but which may contain indirect personal identifiers. A DUA accompanies their distribution by 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)
Substitute unique participant identifier to replace an existing participant identifier used during study conduct for additional protection of confidentiality.
An agreement between NIDDK and the originating or submitting organization, such as the study’s coordinating center to accept and distribute data and biological specimens at NIDDK Central Repository.
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.
Centralized location for specimens and data from studies conducted as part of NIDDK mission. NIDDK Central Repository shares specimens and data with the research community through a web-based system, Resources for Research (R4R).
NIDDK-sponsored clinical research studies that are currently collecting data and/or specimens.
An NIDDK sponsored network or study that deposits resources generated by the conduct of clinical study protocol(s) into NIDDK Central Repository.
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. The 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 page on NIDDK Central Repository website that a user fills out to apply to receive data 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 applicant.
A specific form of a Materials Transfer Agreement (MTA) between NIDDK and the requesting organization to use specimens and associated data provided by NIDDK Central Repository for secondary or confirmatory research.
Data files containing biological specimen count information from participants in NIDDK-sponsored studies which can be downloaded by the originating study team for the purpose of reconciliation with internal documentation.
Unique combination of letters and numbers that identifies each study site that contributes resources to the NIDDK Central Repository.
An NIDDK sponsored study within the mission of NIDDK, that is guided by a unique protocol.
An additional protocol within a study, excluding ancillary or continuation protocols, undertaken to address a separate additional requirement from the goals within the scope of the primary study.