Cost Estimation | Informed Consent | Certificate of Confidentiality | Submission Training

 

Welcome to the NIMH Data Archive (NDA)

This website is designed to help researchers receiving new grants for human subjects research from the National Institute of Mental Health (NIMH) become familiar with the expectations surrounding the sharing of their data and the process set up to deposit and share those data through the NIMH Data Archive (NDA). This section of the website will walk you through the process to prepare your Data Sharing Plan and submission project, make your data as consistent as possible with data from other laboratories, and report publications to NIMH. Please contact us at NDAHelp@mail.nih.gov with any questions or comments.

NDA accepts human subjects research data related to mental health. If you are expected to or planning to contribute data, you must meet the following prerequisites:

1. Obtain Informed Consent.
2. Collect from participants the PII needed to create an NDA GUID.
3. Estimate the cost of data sharing (see Cost Estimation).

Once the prerequisites are considered, follow these steps:

1. To understand NDA, read the NDA Policy.
2. Complete the Data Submission Agreement

   The principal investigator must complete the Data Submission Agreement and have it signed by a Signing Official at their NIH-recognized institution. If you don't know your institution's Signing Official, contact us at the NDA Help Desk for assistance. Once completed, this form should be emailed to the NDA Help Desk.

3. Request an NDA Account

   Create an account here to use in creating GUIDs, submitting data, and managing your project's Collection. All personnel working on the project including the PI will need to create their NDA account.

4. Define Data Expected for Submission

   Create a list of all the data that you plan to collect, as defined in NDA Data Dictionary structures along with the number of subjects, the initial submission date and the anticipated share date (based on the Data Sharing Regimen). This list must be created directly in the Data Expected tab of your Collection, once you have created your account and we have received your Data Submission Agreement, and is expected within 6 months of award.

   • Start by clicking the green plus icon next to 'Add New Data Expected' in a Collection. There will be two options available:
     • Search by Data Structure Title – Use this option for data structures that are already defined in the Data Dictionary. Start to type 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. Provide a new structure title and then upload a file using the Choose File button. Provide a scanned copy of the assessment and/or an electronic version of a data definition, if you have already created one. Multiple files can be zipped together and attached.
   • Then, complete the additional information for the Data Expected item:
     • Targeted Enrollment: Enter the number of subjects targeted for the data structure.
     • Initial Submission Date: Using the calendar, provide the initial date on which the data for the structure will be submitted. Refer to the Data Sharing Regimen for more information on submission dates for Raw and Analyzed Data.
     • Initial Share Date: Using the calendar, select the initial date on which the data will be shared. Refer to the Data Sharing Regimen for more information on share dates for Raw and Analyzed Data.

   List changes are reviewed and approved by NDA staff. You can check the status of the approval on the Data Expected tab. If you have uploaded a document for a new data structure, you will be contacted by staff members to develop the data definition.

After, or concurrent with, these steps you and your staff can prepare data for submission:

1. Generate GUIDs

   When submitting data to the NDA, each research participant needs to have an associated GUID. To generate GUIDs using the PII collected at the research site - or to create random identifiers for retrospective studies - review the section on the NDA GUID. Launch the GUID Tool here, from the home page, from the NDA GUID page, or use the command line tool.

   GUID Training

2. Plan for Data Submission

   All data must have a corresponding data structure defined in the NDA Data Dictionary. Many measures are defined. However, if the data you need to submit is not defined you can request a new definition via the creation of the Data Expected list, described above. If the exsiting definition in the Data Dictionary does not meet your needs, contact us at the NDA Help Desk and we will make the necessary changes to make data submission as simple as possible.

3. Validate Data

   Data must be formatted as CSV or txt (tab delimited) files with two header rows. The first row must contain the data structure name and version number. This is listed in the Data Dictionary under short_name. For example, a short_name of abc_community02 would have a submission template of abc_community and version 02. The next header record is the element name. All ensuing rows contain data. See the example template for abc_community. Templates (and definitions) are available to view and/or download by clicking the appropriate link within the data structure in the Data Dictionary section of the website. Once data is harmonized to the data definition, run the Validation and Upload tool to submit data:

   Using the Validation and Upload Tool Tutorial
4. Share Data

   Data submitted to NDA are shared based on the information provided in the Data Expected list, which should be set according to the standard Data Sharing Regimen. Unless a specific schedule for data sharing has been defined in advance, raw data submitted to NDA are generally shared within 4 months of submission. During this time period, data remain in a private state to allow time for the quality of the data to be reviewed by the Collection owner and NDA staff (see SOP-5 Quality Assurance and Quality Control). Datasets contributed to NDA are then shared with those users with appropriate access. Analyzed data is typically shared when published.

   Creating an NDA Study Tutorial

Cost Estimation

There is a cost associated with contributing quality data to NDA. Costs vary based on the type of data contributed, the number of submissions performed, and the number of subjects enrolled. Based upon these constraints, we have provided a cost model as a guideline to assist you in estimation. For NIH applications sharing data with NDA, the results of this cost model should be included in the budget of your application.

NDA Data Submission Cost Model

 

Crafting Informed Consent Language

Research participants consent to sharing their de-identified data in NDA. A plain language description of the NDA is available as an example to assist you in creating informed consent langauge. Please note that NDA does not review or provide feedback on informed consent documents, and the text provided here is only an example to assist you in crafting your own language.

 

Certificate of Confidentiality

NDA has obtained a Certificate of Confidentiality to help protect the data contained in NDA. Language describing NDA's certificate of confidentiality is available for those institutions that do and do not have one.

 

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