The Who, What, and How of Data Submission

Who should be submitting data and when?

• NDA has biannual submission deadlines

• NIMH Data Archive (NDA) Submission Deadlines: January 15^th & July 15^th

  • ^​NDA Collections in the NDA data repository

  • NDA Collection is linked with an NIH-funded granted
  • Data Expected list has an initial submission date set by January/July 15 or earlier
• NIAAA Data Archive (NIAAA_DA) Submission Deadlines: April 1^st & October 1^st

  • ^​NDA Collections in the NIAAA_DA data repository

  • NDA Collection is linked with an NIH-funded granted
  • Data Expected list has an initial submission date set by April/October 1^st or earlier

What do I need to have completed in order to start submitting data?

1. A signed and completed Data Submission Agreement (DSA)

2. Data Expected list

3. Permission to submit to your NDA Collection
4. Global Unique Identifiers (GUIDs)
   1. While the Data Expected list is being completed, researchers should start generating Global Unique Identifiers (GUIDs) for their research participants.
   2. To request GUID Tool access, please ensure you have at least submission permissions to an active NDA Collection, then email the NDA Help Desk at NDAHelp@mail.nih.gov.

What data should be submitted, and does it need to be submitted cumulatively?

• Any newly collected data is required to be submitted in this submission cycle.

• Clinical and phenotypic data types should be cumulative submissions.

• Imaging, EEG, and Omics data types are non-cumulative.

How do I submit data?

1. Download the corresponding Data Structure submission template from the NDA Data Dictionary

   1. NOTE: This is an important step, if you do not use the template provided by NDA your data will not pass Validation.

      1. For those that have aliases within their Data Structure, please use the custom scope in the Validation Tool in order to submit with aliases.
   2. Data Structures can also be downloaded via your Data Expected list.
      1. To view your data structure templates, click the information ("i") icon next to the data structure names in your Data Expected list.
2. Populate the submission templates with your collected data.
3. Submit your data via the Validation and Upload Tool either using:
   1. HTML web version is best used for cumulative data submissions
   2. Python command-line version is best used for large files (e.g. non-cumulative imaging files)
4. More information can be found in the HTML Validation and Upload Tool tutorial

Data Submission Agreement

The Data Submission Agreement (DSA) is used to request permission to submit data to NDA and outlines the terms and conditions associated with data submission.

• The DSA must be completed by the PI.
• The PI cannot delegate completing the DSA through the eDSA Tool to any other researcher.

Access to your NDA Collection is contingent on completing the Data Submission Agreement (DSA).

• The Data Expected list cannot be accessed until the DSA has been completed and processed by NDA.

How do I complete the DSA?

The Principle Investigator (PI) should submit their DSA through the eDSA Tool.

The PI should follow these steps in order to log into tool:

1. Create or link your existing NDA account with your eRA Commons account.
   • You must log into NDA using your eRA Commons account to log into the eDSA Tool.
2. Log in to the eDSA tool using your eRA Commons credentials.
3. Select the grant for which you will be submitting the DSA and then follow the wizard's instructions to complete and electronically sign your DSA.
4. Once you've signed the DSA, NDA will notify your selected Institutional Signing Official (SO) to access the eDSA tool to review and electronically sign the agreement. Your SO will not need to create an NDA account to access the tool.

I received an HTTP 403 error when trying to access the eDSA Tool. What do I do?

• Clear your browser's cache
• Use an incognito/private window to access to the eDSA Tool.

If the issue persists, please contact the NDA Help Desk at NDAHelp@mail.nih.gov for further assistance.

Data Expected List

Data Expected is a list of Data Structures, which have submission templates used to collect data, the accompanying targeted enrollment of human participants from which data will be collected, and the initial dates for data submission and data sharing for that collected data.

• You must have admin permissions to add/edit the Data Expected list.
  • The PI or any user with admin permissions can update/add a user with the appropriate permissions.

How do I know if my Data Structure is ready for submission?

• If you are not requesting any changes to your Data Structures: you can submit data now!
• The 'Requested' status in your Data Expected list does not hinder you from submitting data.
• To view your Data Structure submission templates and see if they are ready for submission, please click the information ("i") icon next to the Data Structure names in your Data Expected list.
  • If the pop-up says "Structure not yet defined": The data curation team is still working on your Data Structures and preparing your submission template.
  • If the pop-up provides the title and short name of your Data Structure, your Data Structure is ready for submission!
    • Click on the short name to visit the Data Structure's page and download the submission template by clicking "Submission Template" under the Downloads section.
• If you requested changes to your Data Structures and have not yet received a submission template: Please email NDAHelp@mail.nih.gov with your NDA Collection ID and the structure name for an update.

Should I submit any data if NDA is still working on data mapping/curation?

• Yes! You should submit data for the Data Structures that are approved on your NDA Collection!
• Your NDA Collection has a "Research Subject and Pedigree" Data Structure that is required for each researcher to submit data.
• Your NDA Collection could also have some Common Data Elements (CDE) that will require data submission by the end of your grant.
  • When your NDA Collection is created, NDA will populate your Data Expected list with the CDE structures that are correct for your NDA Collection.

When will my data structures be ready for submission?

• We advise you to complete your Data Expected list one month before the submission cycle begins.
  • For NIMH Data Archive NDA Collections
    • November 1^st for the January 15^th submission deadline
    • May 1^st for the July 15^th submission deadline
  • For NIAAA Data Archive NDA Collections
    • February 1^st for the April 1^st submission deadline
    • August 1^st for the October 1^st submission deadline
  • Submitting your requests at this time ensures your data structures will be approved in time for the submission deadline.
• If requests for new structures or structural changes are made after the above dates, your Data Structure(s) will likely be ready for the next submission deadline.
  • Data curators will do their best to get your Data Structures ready for submission.
  • Be on the lookout for any emails from our data curation team updating you on the status of your Data Structures!

How do I add existing data structures to Data Expected list?

1. Research which data structure best matches your data expected by searching the NDA Data Dictionary.
2. Visit your NDA Collection, and click "New Data Expected" under the Data Expected tab.
3. Use the "Search by Data structure Title" option
4. Enter the target enrollment, the initial submission date, and the initial share date.
5. Then search for the data structure name either by the long or short name and select the appropriate Data Structure.
6. Then click Add Data Expected.

How do I create new data structures?

1. Visit the NDA Collection, and click "New Data Expected" under the data expected tab.
2. Click Upload Definition, enter the information, add the data structure name, and select the data structure file.
3. Once you do this, a data curator will reach out to the PI regarding the mapping of your data structure and eventually provide the data structure's submission template.

How do I request changes to existing data structures?

1. Download the "Definitions" file from the Data Structure page that you wish to modify.
   • This should be a .csv formatted file and can be edited in Excel.
2. If there are additional Data Elements you wish to add:
   1. Append the new element as a new row in red text.
   2. Search to see if it already exists in the NDA Data Dictionary.
      • If that Data Element already exists in another Data Structure, use the exact same ElementName as it appears in the other Data Structure.
      • If no element in the NDA Data Dictionary is appropriate, request a new Data Element.
      • Make sure the ElementName you propose does not match any existing elements by searching the Data Dictionary with your proposed name.
3. If there are Data Elements you wish to change,
   1. Highlight them in yellow (e.g., if you want to change 'my_raw_score' from 'Integer' type to 'Float' type, highlight the corresponding cell that says 'Integer' in yellow).
   2. Be sure to save this file in a spreadsheet format (e.g., xlsx) so that your red text and yellow highlights are saved.
4. Email the NDA Help Desk with the following:
   1. An outline of the changes/additions you wish to make.
   2. A justification for the change.
   3. The modified "Definitions" file as .xlsx attachment.
   4. Your NDA Collection ID.

Validation and Upload Tool

The Validation and Upload Tool can be used at any time during your data submission process to validate your data against the NDA Data Dictionary.

• NDA strongly encourages all submitters to use this tool as frequently as possible to ensure your data is harmonized correctly.
• The Validation and Upload Tool is accessible to users with at least submission permissions to an NDA Collection.

What should I do if I receive an error when submitting data via the Validation and Upload tool and do not know how to fix it?

• Users can submit data through the Validation and Upload Tool even if warnings are present.
• If you receive an error in the HTML Validation and Upload Tool and are unsure of how to move forward:
  • Scroll down to the bottom and click Request Help while you are already in the tool.
  • That will send the NDA Help Desk more information to help troubleshoot the issue.
  • Please include all the information including the: Error message and NDA Collection number.
• If you receive an error in the Python version, please email the NDA Help Desk and include:
  • A screenshot of the error, that shows as much of the screen as possible.
  • Your NDA Collection ID.
  • The Data Structure(s) you are submitting .

If QA errors were identified from a previous submission cycle, do I still submit data?

• Please correct the QA errors before doing a new submission!
• Users cannot submit new data with the resubmissions.
• Please email the NDA Help Desk at NDAHelpDesk@mail.nih.gov once you've submitted your corrected files along with your NDA Collection ID.

Submission Exemptions

Submission exemptions notify NDA that data may not be submitted during the upcoming/current submission cycle.

• These can be submitted at any time before or during the submission cycle.
• Submission exemptions can be submitted via the Data Expected tab of your NDA Collection.
  • Users must have submission or admin permissions to submit a submission exemption.

Types of Exemptions