Data Contribution

NDAR accepts human subjects research data related to autism. For those planning to contribute data the following prerequisites are required:

1. Obtain Informed Consent
2. Collect the PII data associated with the NDAR GUID
3. Estimate the cost of data sharing (see Cost Estimation)

Once the prerequisites are considered, follow these steps:

1. Read the NDAR Policy.
   All data in NDAR is de-identified and is typically shared with qualified investigators within 4 months from the date of submission. However, NDAR has an Ongoing Collaboration policy allowing restricted access to data for an investigator determined period of time.
2. Complete Data Submission Agreements
   To contribute data to NDAR, the principal investigator must complete the Data Submission Agreement and have it signed by a signing official at an NIH recognized institution. If you don't know your institution's signing official contact us at ndarhelp@mail.nih.gov for assistance.
3. Request an NDAR account
   Email the signed scanned submission agreement to ndarhelp@mail.nih.gov or complete the online account request form.

   Create an Account / Request Permissions [6:54]
   Last Updated: September 25, 2010

   For NIH funded projects, your account will be approved within two (2) business days. For non-NIH funded projects, please allow five (5) business days for approval. Other personnel who should be given access to your Collection should request accounts using the online account request form. They can then be given access to submit and query data in the Collection.

4. Review Your Collection
   NDAR staff will have created your Collection. The Collection in NDAR is a virtual container within the NDAR Portal accessed following login from "My Collections." Ensure that the title, investigators, description, and NIH grants are accurate as that information will be made available when your data is shared (see http://ndar.nih.gov/data_from_labs.html ). You or your staff are now ready to prepare and submit data.

   Setting up a Collection [3:11]
   Last Updated: September 25, 2010

5. Generate GUIDs
   Most data submitted to NDAR must have a 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 NDAR GUID.

   GUID Tool [7:04]
   Last Updated: August 29, 2011

6. Plan for Data Submission
   All data must have a corresponding data structure defined in the NDAR Data Dictionary. Most published measures are now defined. However, if the data you need to submit is not defined or will not meet your needs, contact us at ndarhelp@mail.nih.gov, and we will make the necessary changes to make data submission as simple as possible.

   For imaging data, NDAR provides an optional tool (see Imaging Tutorial) that extracts header information from your DICOM and NIFTI imaging files and prepopulates that data in the imaging data structure .

   For -OMICS data (e.g. Genomics, Proteomics), you must first create an experiment (see Defining a Genomics Experiment in NDAR), then include the experiment_id with the sample definition. Subject definition is also required.

7. Validate data.
   Data must be formatted as CSV files with two header records. The first record must contain the data structure name and version number of that data structure. 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 02. The next header record are the element_names. All ensuing rows contain your data. Here's an example template for abc_community. Templates (and definitions) exist for every data structure by going to the Data Dictionary and selecting the appropriate data structure.

   Preparing Clinical Data for Submission [5:37]
   Last Updated: September 25, 2010

   Now you are ready to validate your data. NDAR has developed a Validation Tool to check all data to ensure that it is harmonized to the NDAR data standard. The Validation Tool, which can be used independently of NDAR, ensures the following:

   1. NDAR data element names are used. An alias capability allows you to map your names to the NDAR name, or you can do this mapping within your system.
   2. An element that is designated as "Required" must be provided for your data to pass validation.
   3. If defined, value ranges must be met or the NDAR value ranges must be adjusted if your data falls outside of defined value ranges.
   4. "Conditional" fields ensure the entry of certain values based upon other fields (e.g. zygosity is conditionally required if twin_study = Yes).

   Using the Validation Tool [9:38]
   Last Updated: December 23, 2011

   Additionally, NDAR provides a fairly simple translate capability to translate some values that may exist globally within your data. For example 'Y' can be translated to 'Yes' and 'Male' to 'M' which may be useful for you when submitting data.

8. Submit Data.
   Once your data passes validation, you can then submit it to NDAR. To do this, we provide a simple tool that allows for the efficient transmission of data to a Collection where you are the owner or have submission privilege.
9. Share data.
   Unless a specific schedule for data sharing has been defined in advance, data submitted to NDAR is generally shared within 4 months of submission following QA by NDAR staff (see SOP-5 ). Previous submissions on the same data (relevant to clinical data which is usually submitted cumulatively) will be archived by NDAR staff. Additionally, any available documentation describing how the data was collected, methods, and/or software should be uploaded into the Collection.

   For data associated with publications, we encourage the creation of an NDAR Study, allowing cohorts to be defined and subjects to be associated to those cohorts. When shared, the Study will appear in Data by Papers with a link from the publication in Pubmed to NDAR and the underlying data. See defining an NDAR Study for more information.

Cost Estimation

There is a cost associated with contributing quality data to NDAR. 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. For NIH applications sharing data with NDAR, the results of this cost model should be included in the budget of your application.

NDAR Data Submission Cost Model

Informed Consent

As described in the NDAR data sharing policy for prospective studies, participants consent to sharing their de-identified data in NDAR. A plain language description of NDAR is available. Additionally, NDAR has developed a video and printable brochure explaining NDAR for research participants that may be of use in the informed consent process.

Certificate of Confidentiality

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

Data Sharing Regimen

NDAR has outlined a schedule that includes separate timelines for "descriptive data" and "analyzed/experimental data," as defined in the Data Sharing Policy. This policy is included in the terms and conditions of most autism-related grant awards. Please contact ndarhelp@mail.nih.gov if more specific guidance is needed.