NDA Definitions and Terms

Cumulative Data: A dataset that includes all data collected from the beginning of the study to a designated time point; each submission replaces previously submitted datasets in order to avoid the challenges of tracking interim changes or corrections in the database. Data containing references to large files (e.g., -omic, imaging, and other rich data types), may be provided incrementally for efficiency reasons.

Data: Data include all original data elements (variables) obtained from research and clinical assessments and information obtained via interviews, direct observations, laboratory tasks and procedures, records reviews, genetic and genomic data, neuroimaging data, psychophysiological assessments, data from physical examinations, etc. collected at the individual, human-subject level. Data also include any additional data elements derived or calculated from the original data elements. The following are not included as data: laboratory notebooks, preliminary analyses, drafts of scientific papers, plans for future research, peer review reports, communications with colleagues, or physical objects, such as gels or laboratory specimens.

Data Expected: The list of all data structures in which data will be collected and submitted for a given collection as well as targeted enrollment numbers, initial submission, and initial sharing dates for each structure.

Data Submission Agreement: The Data Submission Agreement is a policy document required to be submitted prior to providing permission for the submission of data. This document must be signed by the Principal Investigator as well as an authorized business official with signature authority (SO) as defined in the eRA Commons system from the PIs institution which must also be covered by a Federal Wide Assurance (FWA).

Data Structure – A table in the NDA Data Dictionary that represents a single measure, data collection instrument, or assessment. These are updated regularly as new projects add variables, create aliases, and update descriptions; all changes are recorded in the change history record. Users can download data collection templates to simplify data collection and submission to NDA.

Experiment Definition Tool: An online tool that allows the Principal Investigator to specify important meta-data about the experimental procedure that would to allow other researchers to replicate the experiment. For -omics data, this meta-data includes the experimental molecule, the technology and experimental platform, protocols used for molecule and experiment preparation and kits used for these purposes, as well as names of analysis software, experimental equipment, and description of analysis protocols. For neurosignal recordings, meta-data includes timing sequences, event definition, and acquisition hardware/software specification.

Global Unique Identifier (GUID) – A computer generated alphanumeric code that serves as a common subject identifier across all NIMH Data Archive studies and is unique to each individual participant.

Human Subjects Research – Research conducted on a living individual about whom an investigator (whether professional or student) conducting research obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

NDA Collection: A virtual container and organization structure for data and associated documentation from one grant or one large project/consortium. It contains tools for tracking data submission and allows investigators to define a wide array of other elements that provide context for the data, including all general information regarding the data and source project, experimental parameters used to collect any event-based data contained in the Collection, methods, and other supporting documentation. They also allow investigators to link underlying data to an NDA Study, defining populations and subpopulations specific to research aims.

NDA Study: A virtual container for data, by paper or other public disclosure. An NDA Study allows cohorts, measures and methods from a publication to be defined and associated with the underlying data in NDA. Researchers are expected to create an NDA Study for each publication/presentation resulting from data submitted to NDA.

NCT# – A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.

NDA Data Dictionary – A database of over 2,000 tables, each of which is a single data structure that has been harmonized to a measure, instrument, or assessment. All data submitted to NDA is submitted to one of these structures and allows researchers to easily query across the entire NDA database.

NDA Data Submission Agreement (DSA) – A document that outlines the NDA Data Submission Terms and Conditions and must be signed by the Principal Investigator and their authorized institutional business official prior to providing access to their collection.
Neuro-signal Recordings: Currently defined and accepted types of data broadly referred to in NDA materials as Neuro-signal Recordings data include EEG, EGG, and Eye-Tracking.

NIAAA Guide Notice (NOT-AA-19-020) – a Federal Guide Notice issued July 31, 2019 describing NIAAA’s policy whereby investigators and their institutions are expected to submit grant-related human subjects data to the NIAAA Data Archive.

NIAAA Data Archive (NIAAADA) – NIAAA data repository housed in the NIMH Data Archive.

NIAAADA Data Sharing Plan (DSP) – A template-based amendment to the grant application, completed by the PI and approved by the PO, that contains standard language for how the PI plans to share data with the NIAAA Data Archive and thus comply with the NIAAA’s data sharing policy (NOT-AA-019-020).

NIAAADA Data Sharing Terms & Conditions – A document that outlines the NIAAADA data submission and sharing policies and procedures, include key milestones throughout the grant lifecycle.

NIMH Data Archive (NDA) – NIMH Data repository system which houses the NIAAA Data Archive.

Omics data: NIAAADA accepts electronic -omics (genomics, proteomics, metabolomics, etc.) Projects submitting -omics data should use the summary data structure Genomics Subject, rather than the standard Research Subject structure mentioned in the section on clinical/phenotypic data. Originally created for genomics data, this structure also accommodates all other types of -omics data.

Processed Images: Derived data generated as the final result of image analysis applications in any standard medical research format (e.g. NIFTI, AFNI, etc.). If applicable, supporting de- identified video and imaging materials that define the experiment (e.g., timing sequences in fMRI) should accompany processed images. Intermediate image datasets should not be submitted unless the investigator feels that they are pertinent.

Program Officers and Grants Management Officials (PGMO) collections dashboard – a website portal used by PGMO to view grant-related, summary compliance information of data submitted to the NIAAA Data Archive and to access all individual collection pages.

Raw Unprocessed Images: Data acquired from a scanner in a standard medical imaging format. DICOM format is preferred.

Research Subject Data Structure: Research subjects are expected to be characterized using the Research Subject data structure or, if genomics data are collected, the Genomics Subject data structure which allows for demographic, pedigree, sample location, and diagnostic information to be reported for subjects.

Subject-level data – the information collected and maintained on individual human research subjects.
Supporting Documentation: Researchers are expected to provide clear documentation to enable other investigators, who are unfamiliar with the dataset, to understand and use the data. Supporting documentation may include non-copyrighted data collection forms, study procedures and protocols, variable coding algorithms and statistical analyses, data dictionary rationale, exclusion criteria, website references, a listing of major study publications, and the definition of a genomic experiment using the NDA Experiment Definition Tool. Definition related to a specific finding or publication is to be defined and documented through the NDA Study feature. NIAAA expects some specific supporting documents be provided for all Clinical Trials:

  • Clinical Trial Protocol

  • Assessment schedule of visits (if not already in the protocol)

  • Operating procedures (e.g., Manual of Operations or Standard Operating Procedures), if available

  • Case Report Forms (CRFs) and/or assessment instruments