Contribute

Data Contribution | Cost Estimation | Informed Consent | Certificate of Confidentiality | Data Sharing Regimen

Data Contribution

NDAR accepts human subjects research data related to autism. All individuals planning to contribute data must meet the following prerequisites:

  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.

  2. Complete Data Submission Agreement

    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 and scanned submission agreement to ndarhelp@mail.nih.gov.  You can also complete the online account request form and provide the name(s) on anyone who will be authorized to generate GUIDS or submit and query your data before it is shared. NDAR will then establish a Collection similar to those listed at http://ndar.nih.gov/data_from_labs.html.

  4. Define Data Expected for Submission

    NDAR staff will review the researcher's grant application and create a list of data expected to be submitted to NDAR. This list will include expected dates of submission as well as dates for sharing of the data. Researchers will review this information and provide feedback to both NDAR staff and their program officer. This list will be finalized and agreed upon between NDAR, the researcher and the program officer to permit adequate tracking of submissions.

Once you have access, you and your staff can prepare data for submission:

  1. Generate GUIDs

    Human subjects 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.

  2. 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 the Data Dictionary does 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.

  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 autism data definition, run the Validation and Upload tool (these are now combined) to submit data:

    Validation and Upload Tool
    Instructions

    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 they are 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. You can also 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 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.

  4. Share Data

    Unless a specific schedule for data sharing has been defined in advance, data submitted to NDAR 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 NDAR staff (see SOP-5 Quality Assurance and Quality Control). Datasets contributed to the NDAR Central Repository are then shared with those users with appropriate access.

  5. Create an NDAR Study

    Research results are expected. Send us a write-up of your results, data analysis methods, and subject GUIDs for each cohort. NDAR will then make your results available through our Data from Papers page  and link the publication listing in PubMed back to your raw data. This should be done prior to a publication to allow us time to share your results on the same day that it is published.


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



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. In addition, the grantee, program officer and NDAR will agree upon a timeline for data submission and data sharing (See Define Data Expected for Submission) Please contact ndarhelp@mail.nih.gov if more specific guidance is needed.