Submission Planning
NDAR is interested in human subject research data relevant to ASD. Currently, NDAR accepts phenotypic, genetic, and imaging data.
While it is important to consider all of the elements for submission of data to NDAR prior to the commencement of a study,
NDAR can also accept data that have already been collected as part of a completed or ongoing study.
An investigator should consider the following when planning to contribute data to NDAR.
Step 1: NDAR Policy Review
First review NDAR
Policy and Procedures. The policies applicable to NDAR are:
- NDAR Policy – The NDAR Policy is the primary, overarching policy of NDAR addressing considerations for providing data to NDAR,
outlining the requirements for data submission, and the protection of research subjects.
- NDAR Ongoing Study Policy Addendum – This addendum to the NDAR Policy specifies the use of NDAR to share data with
specified collaborators during ongoing research, with no expectation that the data will be broadly shared until after
primary objectives are met or at the time of publication.
Please note: Any data that are contributed to the NDAR Central Repository are subject to the laws and
regulations of the United States Federal Government. Please review
FAQ #22: Are data within NDAR subject to a Freedom of Information Act (FOIA) request?
Additionally, While NDAR has obtained a Certificate of Confidentiality (which helps to protect the privacy of human research participants)
for the data contained in NDAR, investigators are encouraged to obtain their own Certificate of Confidentiality for data contained at
their research site(s) or made available to NDAR through data federation.
More information is provided in the section on Informed Consent below.
Step 2: NDAR Submission Agreement
Prior to planning a data submission to NDAR, an investigator will need to complete the NDAR Data Submission Agreement. This document must be signed by both the investigator responsible for collecting data and an NIH-recognized institutional business official. Multiple Data Submission Agreements may be required for different projects so it is possible for an investigator to have a few NDAR Submission Agreements uploaded to their profile. Once completed, the Data Submission Agreement should be saved electronically and included in the request for an NDAR account. The Submission Agreement will then be associated with the NDAR Collection.
An association of at least one Data Submission Agreement to an NDAR Collection is needed.
However, if multiple institutions are responsible for acquiring research data, and there is no
institution responsible for data coordination, each institution may choose to complete the NDAR Data Submission Agreement
and associate it with the NDAR Collection. See NDAR FAQ #23 for more information on this issue.
Step 3: Informed Consent and the GUID
It is important for investigators to ensure that they have obtained appropriate informed consent when considering sharing human subject research
data with NDAR. To generate a GUID, a research subject’s legal name at birth, date of birth, gender, and city/municipality of birth is needed.
This information is not available to NDAR but will need to be collected and entered into software at the investigator site to generate a valid GUID.
The GUID and the data in NDAR is de-identified. However, NDAR has sample informed consent language that an institution may consider using.
- For institutions with a certificate of confidentiality, see this sample language (Microsoft Word format)
- For institutions without a certificate of confidentiality, see this sample language (Microsoft Word format)
For an overview on certificate of confidentiality refer to
http://grants.nih.gov/grants/policy/coc/index.htm for more information or
contact NDAR staff.
Refer to Retrospective Studies below if the informed consent or data is insufficient to generate a GUID.
Step 4: Data Sharing Considerations
The following are considerations for how to best share data with NDAR:
Prospective Studies
Generally, NDAR would like to receive non-proprietary behavioral and diagnostic data as early as possible. Making this information available early
in the research process allows other investigators to understand general characteristics of the subjects enrolled. These data are usually provided biannually,
but any appropriate time schedule can and will be supported. NDAR expects all prospective studies to include a GUID in all prospective studies/projects/cohorts.
Data contributed to NDAR are expected to be shared within 9 months as defined by the NDAR policy. Data is generally shared broadly with researchers
who have completed the Data Access Agreement and have been approved by the NDAR Data Access Committee. NDAR also supports sharing of data with specific individuals
for the purpose of scientific collaboration through NDAR’s Ongoing Study capability. Proprietary or incomplete data should not be provided to NDAR until it is ready to be shared,
either broadly or through NDAR's Ongoing Study capability.
Although NDAR has developed tools (e.g. Validation Tool, Query Tool, and coming soon the Data Dictionary Tool) that make it simpler for a researcher to contribute data to NDAR, we recognize that there is a cost associated with contributing quality data to NDAR. Costs will vary based upon the type of data contributed, the number of submissions performed and the number of subjects enrolled.
For example, a five year research project containing 8 standard assessments contributed semi-annually and 10 custom assessments, imaging data,
and genetic data contributed in year 5 of the grant for 100 enrolled subjects is estimated to require 60 hours of an investigator’s time and
240 hours of a Data Manager’s time over five years. Contact NDAR at ndar@mail.nih.gov
to discuss the specific tasks and associated hours that a researcher should consider when estimating costs to contribute research data to NDAR.
Scientific Collaboration using NDAR’s Ongoing Study Capability
Through NDAR’s Ongoing Study capability, an investigator may choose to collaborate with specific individuals, allowing for the limited sharing of data until publication or primary objectives are met. Defined as an addendum to the NDAR Policy, the Ongoing Study Policy allows for scientific and/or data collaboration with individuals determined by the investigator while research is ongoing.
Refer to the NDAR Ongoing Study Addendum in Policy and Procedures for more information.
Retrospective Studies
NDAR supports the submission of research data from completed studies. For all research data submissions, the NDAR
Data Submission Agreement is required.
However, for retrospective studies, the data needed to generate a GUID may not be available or the informed consents may be inadequate for an investigator to provide data
accompanied by a valid GUID. To account for this, NDAR provides the capability to generate pseudo-GUIDs, which are random identifiers that, unlike GUIDs, are not derived
from data associated with the research subject. Not having a valid GUID associated has limitations in NDAR. However, NDAR will accept data without a valid GUID for retrospective studies.
Data Federation
The NIH is interested in allowing researchers to more easily access relevant research data resources that may exist elsewhere. This is possible using the data
federation capabilities available in NDAR. This capability has two distinct advantages:
- It allows the owner of the data to remain in control of the federated data and their data access policies.
- Once established, operationally, federated data resources are much simpler to maintain.
Generally, NDAR encourages federated data resources to allow some data to be made broadly available. To support the sharing of proprietary data, often subject to specific
access policies, NDAR supports the use of separate Data Access Committees, established outside of the NIH, allowing a federated data resource to
grant access to more restricted views of their data through NDAR.
Refer to NDAR Policy and Procedures for more information.
Step 5: Data Submission
Once an investigator is ready to submit data to NDAR, the following general steps are followed. These are defined in detail in the
Procedures section of Policies and Procedures:
- Request an NDAR Portal Account.
- Upload a signed Submission Agreement when requesting an account. Refer to Accessing NDAR for more information
- When the account has been approved:
- Login to the NDAR Portal
- Create an NDAR Collection
- Associate the approved Submission Agreement to the NDAR Collection
- Provide appropriate descriptive information.
- Grant appropriate individual accounts (e.g. Data Manager) access to the NDAR Collection(s)
- Format research data in preparation for submission to NDAR (see Data Definition)
- Validate the data using the NDAR Validation Tool, which is also used to create an NDAR submission package.
- Navigate to the NDAR Collection, select manage submission, and upload the submission package. A confirmation email will be provided and the data will be loaded into the NDAR Central Repository.
- Once in NDAR, the data will become available only to the investigator and investigator/NDAR staff to allow for QA/QC procedures to be completed. Data will remain private to these groups until the investigator initiates the workflow to share NDAR data as defined in Data Sharing.
