Collection Creation | Permissions | Data Sharing Terms and Conditions | GUID Tool | Data Expected | NIAAA_DA Data Standards

NDA Collection Creation

Each project or grant contributing to NDA has an associated NDA Collection. This is the virtual container into which data are submitted, and it also contains tools to help guide your project through the submission process.

NDA Collections are created by NDA Staff automatically, shortly after a grant is awarded. This triggers a welcoming notification sent to the Principal Investigator of the project and responsible NIH Program Official introducing them to NDA and outlining the initial steps in the process. The first step is generally the completion of the Data Submission Agreement (DSA).

Once we have received the completed Data Submission Agreement (DSA), ownership of the NDA Collection will be assigned to the Principal Investigator's NDA user account. By default, only the Principal Investigator will have access to their NDA Collection.

Permissions

It is the responsibility of the Collection Owner (i.e., the Principal Investigator) to delegate privileges as needed to additional staff members - this can include delegating the ability to assign privileges to another project administrator, like a Data Manager. To do this, the NDA Collection owner will access the Permissions Tab in their NDA Collection. This provides a list of all users who have various levels of access to the NDA Collection. "Submission" privileges are needed to define Experiments and upload data. "Admin" privileges allow editing of other user privileges, including the ability to add new users to the NDA Collection, and edit the Data Expected list. All personnel who will be working with the NDA system will need their own user account, without exception.

Data Sharing Terms and Conditions

All NDA Collections are required to submit subject-level data biannually. The first data submission date is the second cycle after the grant is awarded. If there are no data available to submit for the first data submission cycle, investigators may delay the first data submission by one cycle by updating submission dates on the Data Expected Tab of their NDA Collection to the next submission cycle date. No approval is necessary.

To delay the first submission by more than one cycle, investigators must request a submission exemption and include justification language. The request is initiated from the NDA Collection page, in the Data Expected Tab. Program staff will be notified and must approve or deny the request.

To delay a submission that is not the first data submission, investigators must request a submission exemption, as described above. Program staff will be notified and must approve or deny the request.

Clinical and phenotypic data submissions are cumulative (i.e., submitted in full upon every submission), for QA purposes and to capture data updates over time. Cumulative submissions increase data quality and integrity. Neurosignal recording and non-genomics omics data submissions are not cumulative (i.e., they are submitted as they are collected and append together in the NDA database).

All data are shared automatically two years after the original end date of the grant. Any subject-level data and the associated analyzed data used in a journal publication will be shared at the time of publication, even if the publication occurs before the two-year automatic share date. PIs may request to share their data before the two-year automatic share date by updating the sharing dates in Data Expected.

Related Notices

• NOT-AA-23-002: Revised: Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)

GUID Tool

When data are uploaded to NDA, each study participant must be assigned a Global Unique ID, or GUID. This identifier is created using a no-cost tool maintained by NDA. To create a GUID, the PI needs to collect a specific set of information from the participant's birth certificate, and account for this in the informed consent documents and with their IRB. For information on what needs to be collected and how the tool is used, please visit our full page on the NDA GUID.

Anyone in the research lab who will be creating GUIDs can request access to the GUID Tool after they've created their account by first obtaining at least submission permissions to an active NDA account and then emailing the NDA Help Desk to request GUID Tool access.

Data Expected

The NDA Data Expected List is the primary tracking mechanism for your data submission project, and you, or a designated member of your staff, can set the Data Expected List up in your NDA Collection. The NDA Data Expected List in its completed state is a list of all measures/instruments you are collecting, along with final targeted enrollment numbers, and the initial submission and sharing dates for each item. The purpose of the Data Expected List is to track your submission progress, enable you to set flexible data submission and sharing dates in accordance with the Data Sharing Terms and Conditions, and to define new data structures, if needed, to upload all of your data. To get started creating your Data Expected List:

1. Add an item to the Data Expected List by clicking the "Add New Data Expected" button in the Data Expected Tab of your NDA Collection page. There will be two options available to you:

•Search by Data Structure Title: Use this option for data structures that are already defined in the NDA Data Dictionary. Begin by typing a data structure name in the search box and a list of options will be provided. Select the appropriate option.

•Upload Definition: Use this option for data structures that have not yet been defined in the NDA Data Dictionary. Enter a descriptive title and then upload a file using the “Choose File” button. Provide a PDF copy of the assessment or questionnaire, manuals/codebooks, and/or an existing definition from your own database to help NDA staff define the structure. Please provide anything that might be helpful in drafting this definition.

Once an item is added to the Data Expected List, NDA will be notified, and a Data Curator will be assigned to your NDA Collection. The Data Curator will serve as the NDA primary point of contact for the remainder of submission process, in charge of helping to create new data structures and harmonizing existing structures to meet the needs of the project. The Data Curator will reach out to project staff with questions, or once the draft structures are ready for review.

2. Set a Targeted Enrollment: Enter the number of unique participants targeted for the data structure over the course of the entire project.

3. Set an Initial Submission Date: Using the calendar, provide the initial date on which the data for the structure will be submitted. By default, this would be the deadline of the second biannual submission period after your award. If you have questions about submission dates, please contact the NDA Help Desk.

4. Set an Initial Share Date: Using the calendar, select the initial date on which the data will be shared with the general research community. By default, this will be two years after the end date of the project.

Please note that changes will not take effect until the "Save" button is clicked and a success notification is received. List changes are reviewed and approved by the NDA staff. Project staff can check the status of approval on the Data Expected Tab. If you have uploaded any documents for a new Data Structure, you will be contacted by the NDA staff to develop the data definition.

The Data Expected List can be changed to accommodate any unexpected deviations in the plans for enrollment or data collection as the project progresses, simply by visiting the Date Expected Tab of your NDA Collection, editing the desired field, and clicking “Save”.

NIAAA_DA Data Standards

All NDA Collections

All NDA Collections are expected to submit a Research Subject and Pedigree Data Structure. The NDA Data Dictionary contains two Research Subject and Pedigree Data Structures: Research Subject and Genomics Subject. Collections submitting omics data should use NDA's Genomics Subject structure. All other Collections should use NDA's Research Subject structure. The Research Subject and Pedigree Structure category of NDA structure contains core information about all study participants, including: diagnosis, phenotype, and family pedigree; information on biosamples that have been collected and/or analyzed, including sample type, description, and the subject ID in a given biorepository; and subject IDs in other information systems. Investigators should create a new entry in the Research Subject and Pedigree Structure every time a subject’s diagnosis or phenotype is updated or a new biosample is collected and/or analyzed.

Clinical/Phenotypic Data Standards

NDA supports an unlimited amount of clinical, demographic, and phenotypic data associated with human subjects research (see Data Dictionary). To ensure the harmonization of data across projects, all data submitted to NDA must conform to a standardized data structure as defined in the Data Dictionary.

Neuro-signal Recordings

NDA accepts evoked response/event-based data from EEG, fMRI, eye tracking, MEG, and EGG experiments. Each of these types of data has one standard structure in the Data Dictionary that can be used to upload the associated files. These are:

• EEG
• fMRI/DTI/PET
• Eye Tracking
• MEG
• EGG

These structures allow you to provide required information and contain a data file element that allows you to specify the path of associated data files for upload. To provide information on experimental parameters used to collect the data (e.g. event/task descriptions, acquisition hardware, postprocessing, etc.) on a participant-record level, these data types also require you to define an Experiment. This is done in your project's NDA Collection, and once it is completed you will receive an ID number that you will need to enter in associated subject records when uploading associated files. Each experiment type has a similar interface and pre-loaded options. When completing all required fields, keep in mind the purpose of the definition is to provide as much information as necessary to recreate the experiment.

Data requiring an experiment definition must be uploaded using its associated data type's subject file template, linked above. All of these have a data element named "experiment_ID". For imaging, this field is conditional and only required if the data is indicated as functional MRI. In all other experimental structures, it is required. The experiment ID number you received when creating the experiment definition should be entered in this column for subject records where the associated files were collected using those experimental parameters.

In this way, researchers accessing your data for secondary analysis can look up the experimental ID number and view important experiment information in your Collection in conjunction with the data files and the contents of the data template to understand its full context.

-Omics Definition

To submit "-omics" data to NDA (e.g. genomics, proteomics, metabolomics, etc.), you will first need to use the Experiments tab of your project's NDA Collection to create an Experiment that defines parameters like molecule, platform, software, etc. You can find a tutorial on using the Experiment definition tool here. Once the Experiment is created, it will be assigned an ID number. You can then use the standard -omics structure (genomics_sample structure) to provide the required sample information, and enter the Experiment ID in the field of the same name. This CSV file includes a field for specifying the path of the associated omics data files you will upload. Once your Experiment is defined, your CSV populated, and files specified, you can upload this data using the Validation and Upload Tool. Please contact us at the NDA Help Desk for more information.

Please note the following -omics standards that may differ from other NDA data types:

• NIAAA_DA expects to receive all electronic -omics data from NIAAA-funded grants. This includes human genomic data and represents a change from the previous policy under which these data were submitted to dbGaP. Awardees who are collecting human genomic data will register with dbGaP. After registration, all data (including but not limited to clinical, genomic, imaging, and phenotypic data) will be deposited in the NIAAA_DA. A link to the NIAAA_DA Collection will be added to the dbGaP registration. NIAAA expects that projects with GWAS data will also submit these data to the Psychiatric Genomics Consortium.
• 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.
• Physical biosamples will not be included in the NIAAA_DA, but reference numbers to biosamples will be included in the NIAAA_DA.

Data Dictionary

NDA has worked with the mental health research community to create a Data Dictionary containing standard structures for hundreds of assessments.

Here are a few notes about the Data Dictionary:

• You can browse structures by Type (e.g. Omics, Neurosignal Recordings, Clinical Assessments), Source (e.g. NDAR, PediatricMRI, AGRE, NDCT) or Category (e.g. Behavior, IQ) to identify available data structures, as well as refine the results displayed with a text search.
• By clicking on the name of a data structure, you can view a list of data elements and their attributes, download the detailed definition and a blank template for the submission of data, and see any related URLs.
• The column "Submission" indicates whether NDA currently accepts data uploads of this structure. If Submission is "Not Allowed" a more current measure usually exists.
• There is a link to a Change History on each structure page that shows all the changes to the structure made within the last six months.
• The Alias column in the structure displays other names that the Validation and Upload Tool will recognize for a specific data element.
• NDA supports translation for data values, allowing data to be converted from a lab-specific value to the NDA-recognized value (e.g. Male to M). While this may be helpful to projects that have already collected data using a different set of values, most projects that are not using the standard should consider performing this conversion prior to submission.
• A web service into our Data Dictionary is available with no authentication required. Please contact us with any questions or consult the documentation.
• Research Subject: This is a general summary structure that allows you to provide one record for each participant indicating the clinical diagnosis.
• Genomics Subject: This structure is required for Omics submission to NIAAA_DA in place of Research Subject. It is similar to Research Subject, but includes other data-/bio-repository identifiers that also allow us to match subjects across these repositories (see Resolve Identifiers).

Clinical Trials

Clinical Trials subject to data sharing expectations must provide certain information as part of their final dataset to ensure it has value to those seeking to use it. These must be provided before the dataset is shared for the NDA Collection to be considered complete.

• Research Subject and Pedigree: This summary structure is described in Standards for all Collections and is expected from all projects including Clinical Trials.
• A ‘Treatment Assignment’ data structure, which maps subjects to treatment groups/study arms over the course of the trial.
• Supporting Documentation: NIAAA expects that the following supporting documents will be uploaded to the NDA Collection before or when the dataset is to be shared, in addition to any other documentation that may be necessary to effectively use the data:

  • 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

• To upload Supporting Documentation, visit the General Tab of your NDA Collection page and click "Add New" next to the Supporting Documentation section. When uploading the file, please provide an informative name and description, and select the file type. Documents set to have an Audience of Qualified Researchers will be available to those with authorized access to the NIAAA_DA. Documents with Public Audience will be available to all.

Data Submission Agreement

Data Harmonization