favicon.ico

U.S. Geological Survey

Data standards are the guidelines by which data are described and recorded. In order to share, exchange, combine and understand data, we must standardize the format as well as the meaning.

HEAL Data Stewards

[HEAL Semantic Search (HSS) 2.0](https://www.healdatafair.org/resources/semantic-search) is now available, bringing a refreshed interface that makes it easier to explore related studies, variables, Common Data Elements (CDEs), and biomedical concepts from a single search; compare how concepts and variables are defined and measured across studies; and access insights from 20 newly added data dictionaries, over 1000 HEAL studies, and 233 CDEs. Get started today by [entering a search term](https://www.healdatafair.org/resources/semantic-search) relevant to your research.

Explore HEAL studies, variables, CDEs, and concepts in [HEAL Semantic Search (HSS) 2.1](https://www.healdatafair.org/resources/semantic-search)!

HEAL Data Checklist and Checklist Tracker

The HEAL-compliant data checklist and checklist tracker tool help investigators along their data sharing journey. While the Checklist offers a step-by-step guide for studies to maintain HEAL Public Access and Data Sharing Policy compliance, the Checklist Tracker Tool provides a more personalized look—showing investigators study-specific updates to indicate which checklist steps their study completed and which are outstanding.

\
Please note: Regardless of when an investigator received their HEAL award, these tools should serve as a vital guide to ensuring study teams complete all necessary steps toward HEAL compliance.

## Checklist Tracker Tool

Enter your study's unique project number, PI name, application number, CTN protocol number (as CTN[number] or CTN-[number]), or HEAL Data Platform ID (HDPID) in the search bar below to see your study's status for steps we can track.


## Guidance for HEAL Data Sharing

Click on each step to see instructions and resources for completing.


Congratulations on your HEAL award! This checklist will guide you through the steps to comply with the [HEAL Public Access and Data Sharing Policy](https://heal.nih.gov/data/public-access-data). 
\
\
**Related Links**
___

- [Guidance for complying with the HEAL Data Sharing Policy](https://heal.nih.gov/data/complying-heal-data-sharing-policy)
- [NIH Policy for Data Management and Sharing](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html), in effect January 2023

Award Received

Is your study a clinical trial? If so, you must register your HEAL study on [ClinicalTrials.gov](https://clinicaltrials.gov/). Indicate your participation in the NIH HEAL Initiative by including “the HEAL Initiative (https://heal.nih.gov/)” in the Study Description section.

\
If you are not conducting a clinical trial, skip this step!

\
**Recommended**
___
Review your data management and sharing plan (DMSP) to ensure it is up to date. If any changes have occurred during the award that affect how data is managed or shared, you should update the Plan to reflect the changes. For more information, [click here](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-185.html).

Register Your Study on ClinicalTrials.gov (if appropriate)

The [HEAL Data Platform](https://healdata.org/landing) supports the discovery, access, and analysis of data generated by HEAL-funded and related studies. Within one year of receiving the award, you must register your study with the HEAL Platform. **Even studies that cannot share data or are not ready to share data can register on the HEAL Platform.** To register your study, complete the following steps:

* [Request access to register your study](https://heal.github.io/platform-documentation/study-registration/requesting-access/)
* [Create a CEDAR account](https://auth.metadatacenter.org/auth/realms/CEDAR/login-actions/registration?client_id=cedar-angular-app&tab_id=FTAI3r6Z2qo), if you do not already have one

\
Once completed, you may [register your study with the HEAL Platform](https://heal.github.io/platform-documentation/study-registration/registering-your-study/). During registration, a study-level metadata input form will be created within your CEDAR account.


\
**Related Links**
___

- [HEAL Platform Study Registration Tutorial Videos](https://youtube.com/playlist?list=PLbQn1DuvP4ch2Z2rwf8sx7wC7zZqX-eoS)
- [Fresh FAIR Webinar: Increase Your Impact Factor: Study Registration On The HEAL Data Platform](https://www.healdatafair.org/events/AAMkAGJiYjdiMDk4LTI2NjktNDQ0Yy1iN2NkLTk0ODE5NTkwZGMwYwBGAAAAAADFCfsravpISIJULhJ6kUB2BwDT2LgfOzJeR4d6_-DuvpGaAAAAAAENAACStECWrhwlT6Ftc2zjZMptAADqm_1CAAA=)
- [*Fresh FAIR* Webinar: Increase Your Impact Factor Part 2: Study-Level Metadata Submission to the HEAL Data Platform](https://youtu.be/6VLbtjO4_wM?si=FUnwKAekjJe-n2Dz)

\
**For Assistance**
___

For assistance with this process, please [reach out to the HEAL Platform team](mailto:heal-support@gen3.org).

\
**Recommended**
___
Review your data management and sharing plan (DMSP) to ensure it is up to date. If any changes have occurred during the award that affect how data is managed or shared, you should update the Plan to reflect the changes. For more information, [click here](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-185.html).

Register Your Study with the HEAL Data Platform

The HEAL Platform uses study-level metadata to enhance search capabilities. In the process of registering your study with the HEAL Platform, a metadata input form will be generated in your CEDAR account. To find the form:
* Navigate to the [CEDAR homepage](https://auth.metadatacenter.org/realms/CEDAR/protocol/openid-connect/auth?client_id=cedar-angular-app&redirect_uri=https%3A%2F%2Fcedar.metadatacenter.org%2F&state=4f8c1f97-fb3c-4530-921d-fcb9321cf927&response_mode=fragment&response_type=code&scope=openid&nonce=05bc1833-908b-4cfb-9c3e-a7344247f715) and log in
* Click on **Shared with Me** on the left-hand side of the page and find your form, titled “HEAL Study Core Metadata”
* Fill out the CEDAR metadata form and be sure to SAVE often by clicking the save button at the bottom of the form
* For helpful tips and tricks for filling out the form, as well as additional information about each metadata field, [click here](https://norc-heal.github.io/cedar-form-docs/)

\
When it is time to submit your data to a repository, the study-level metadata entered in CEDAR will be available for download via the HEAL Platform.

\
**Please note, even studies that cannot share data or are not ready to share data can complete a study-level metadata form.**

\
**Related Links**
___

- [Metadata form tutorial](https://www.youtube.com/watch?v=W8tXLShto5s&list=PLbQn1DuvP4chZNd9gmQgfK0jFoQxjxnXM)
- [*Fresh FAIR* Webinar: Increase Your Impact Factor Part 2: Study-Level Metadata Submission to the HEAL Data Platform](https://youtu.be/6VLbtjO4_wM)
- [*Fresh FAIR* Webinar: Metadata 101](https://www.youtube.com/watch?v=dt1Yhw0cDOo)
- [*Fresh FAIR* Webinar: Metadata 102](https://www.youtube.com/watch?v=RY1_N0-QENY)
- [Metadata Resources](https://www.healdatafair.org/resources/metadata)


\
**For Assistance**
___

For assistance with this process, please [reach out to the HEAL Platform team](mailto:heal-support@gen3.org).

\
**Recommended**
___
Review your data management and sharing plan (DMSP) to ensure it is up to date. If any changes have occurred during the award that affect how data is managed or shared, you should update the Plan to reflect the changes. For more information, [click here](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-185.html).

Complete Your Study-Level Metadata (CEDAR) Form

HEAL Investigators should select a suitable data repository when writing their data management and sharing plan. Repository decisions should be confirmed as soon as possible upon award. Please review the [HEAL Data Repository Selection Guide](https://www.healdatafair.org/resources/guidance/selection) for a list of HEAL-compliant repositories. 

\
When you register your study with the HEAL Data Platform, enter your repository choice. If you already registered and skipped that field, have since changed your repository choice, or need to select multiple repositories, **please update that information in the Platform.** You can do this by contacting the [Platform Help Desk](mailto:heal-support@gen3.org).

\
**Related Links**
___

- [HEAL Repository Selection Tool](https://www.healdatafair.org/repository-decision-tree)
- [*Fresh FAIR* Webinar: Finding A Home for Your HEAL Data](https://www.youtube.com/watch?v=Z3T_ERHaGHw)
- [*Fresh FAIR* Webinar: Open House for HEAL Data](https://www.youtube.com/watch?v=ogfY3emV09Y)

\
**For Assistance**
___

For assistance selecting an appropriate repository, please [contact the HEAL Stewards](https://forms.fillout.com/t/gcVveGMswBus).

\
**Recommended**
___
Review your data management and sharing plan (DMSP) to ensure it is up to date. If any changes have occurred during the award that affect how data is managed or shared, you should update the Plan to reflect the changes. For more information, [click here](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-185.html).

Report Your Repository Selection via the HEAL Data Platform

Common Data Elements (CDEs) are precisely defined and standardized measures, paired with a set of allowable responses or acceptable data types, used systematically across different sites, studies, or clinical trials to ensure consistent data collection. CDEs are often collected using Case Report Forms (CRFs) or questionnaires. The HEAL CDE team has identified a set of core HEAL Common Data Elements (CDEs) that cover nine domains, which are available in the [HEAL CDE repository](https://heal.nih.gov/data/common-data-elements-repository). Additionally, REDCap data dictionaries for all of the core questionnaires within the HEAL CDE program are available in the HEAL CDE Box account. For access, please contact [heal_cde@hsc.utah.edu](mailto:heal_cde@hsc.utah.edu). Clinical pain research grantees collaborate and agree to use common data elements for patient-reported outcomes (PROs). 

\
All HEAL studies collecting data from human participants and planning to use CDEs (even studies outside the clinical pain research portfolio) are strongly encouraged to search for applicable CDEs within the HEAL CDE repository, and use questionnaires from this database if possible.

\
The HEAL CDE program also includes supplemental patient-reported outcome questionnaires across dozens of health domains being used by NIH HEAL Initiative studies. Supplemental CDEs of validated measures that have been reviewed and standardized by the HEAL CDE team can be found in the HEAL CDE Repository. Studies funded in calendar year 2023 and beyond must utilize questionnaires that are within HEAL’s CDE databases. Exceptions will be made on a case-by-case basis if your research is focusing on an area not covered within current questionnaire offerings. 

\
Additionally, all studies using CDEs, regardless of whether they are part of the HEAL repository, will be required to report which questionnaires are being used to the HEAL CDE team at [heal_cde@hsc.utah.edu](mailto:heal_cde@hsc.utah.edu).

\
HEAL Initiative clinical studies using copyrighted questionnaires must obtain use licenses, and share them with the HEAL CDE team and program officer prior to using copyrighted material or collecting data. For more information, please refer to the [HEAL CDE program website](https://heal.nih.gov/data/common-data-elements), review the [HEAL Stewards CDE FAQs](https://www.healdatafair.org/resources/faqs), or contact the HEAL CDE team at [heal_cde@hsc.utah.edu](mailto:heal_cde@hsc.utah.edu).

\
**Related Links**
___

- [NIH HEAL Common Data Elements Repository](https://heal.nih.gov/data/common-data-elements-repository)
- [*Fresh FAIR* Webinar: Common Data Elements (CDEs): Getting More Common All the Time](https://www.youtube.com/watch?v=l2oRKT07RFo)
- [NIH HEAL Common Data Elements Program](https://heal.nih.gov/data/common-data-elements)
- Request access to the shared Box folder with REDCap versions of HEAL Core CDEs by emailing [heal_cde@hsc.utah.edu](mailto:heal_cde@hsc.utah.edu). REDCap Core CDEs will also be available in the [new NIH HEAL CDEs repository](https://heal.nih.gov/data/common-data-elements-repository) soon. 

\
**For Assistance**
___

For assistance with this process, please reach out to the HEAL CDE Program team by contacting [HEAL_CDE@hsc.email.edu](mailto:HEAL_CDE@hsc.utah.edu).

\
**Recommended**
___
Review your data management and sharing plan (DMSP) to ensure it is up to date. If any changes have occurred during the award that affect how data is managed or shared, you should update the Plan to reflect the changes. For more information, [click here](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-185.html).


Use HEAL Common Data Elements to Collect Your Data

Variable-Level Metadata (VLMD), often documented in a study’s data dictionary, describes the variables that are collected as part of your HEAL study. Each piece of collected data is represented by a variable. Variable-level metadata includes:

* Variable name  
* Variable description (which may include variable collection information)  
* How the variable data is encoded  
* Information on common data elements (CDEs) or clinical research forms (CRFs) if used

Beginning in 2024, the NIH will require the submission of VLMD. Submitting your data dictionary ensures your research is Findable, Accessible, Interoperable, and Reusable (FAIR). Your contribution will unlock the full potential of the HEAL Initiative and HEAL Semantic Search by advancing research and promoting data reuse and collaboration.

We realize not all HEAL studies have data dictionaries. If you have a data dictionary, please upload it to the Platform through the [VLMD submission portal](https://heal.github.io/platform-documentation/vlmd/vlmd_submission/) or email it to us at HEALStewards@renci.org. Note that we can accept data dictionaries at any point in your study, even if incomplete\! Data dictionaries inherently should not contain sensitive information such as personal health information (PHI) or personally identifiable information (PII). Data dictionaries will be shared publicly via the HEAL Data Platform and HEAL Semantic Search tool.

**Related Links**
___
* [VLMD Submission Portal](https://heal.github.io/platform-documentation/vlmd/vlmd_submission/)  
* [VLMD Utilities GitHub](https://github.com/HEAL/healdata-utils)  
* [Fresh FAIR Webinar: Metadata 101](https://www.youtube.com/watch?v=dt1Yhw0cDOo)  
* [Fresh FAIR Webinar: Metadata 102](https://www.youtube.com/watch?v=RY1_N0-QENY)  
* [Metadata Resources](https://www.healdatafair.org/resources/metadata)


**Recommended**
___
Review your data management and sharing plan (DMSP) to ensure it is up to date. If any changes have occurred during the award that affect how data is managed or shared, you should update the Plan to reflect the changes. For more information, [click here](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-185.html).


Submit Variable-Level Metadata

When ready, submit your data to the repository (or, in some cases, *repositories*) of your choice. For guidance on submitting data to the repository you selected, follow the appropriate link in the “get started here” column on the [HEAL Data Repository Selection Guide](https://www.healdatafair.org/resources/guidance/selection) webpage.  
   
Be sure to include variable-level metadata (VLMD), often referred to as a data dictionary or codebook, with your submission. VLMD should also be uploaded to the Platform through the [VLMD submission portal](https://heal.github.io/platform-documentation/vlmd/vlmd_submission/) or sent via email to the HEAL Stewards at [HEALStewards@renci.org](mailto:HEALStewards@renci.org). Some repositories may have their own VLMD expectations and curation processes, with which the HEAL Data Ecosystem seeks to align. Helpful resources include guidance on [preparing your data package](https://norc-heal.github.io/heal-data-pkg-guide/) and the [VLMD utilities GitHub](https://github.com/HEAL/healdata-utils). 

Additionally, don’t forget to make sure that your repository choice is accurately represented in the HEAL Data Platform\! If you have not updated your repository choice, **please do so as soon as possible** by contacting the Platform Help Desk at [heal-support@gen3.org](mailto:heal-support@gen3.org).

**Related Links**
___
* [Fresh FAIR Webinar: Finding A Home for Your HEAL Data](https://www.youtube.com/watch?v=Z3T_ERHaGHw)  
* [HEAL Data Packaging Guidance](https://norc-heal.github.io/heal-data-pkg-guide/)  
* [VLMD Submission Portal](https://heal.github.io/platform-documentation/vlmd/vlmd_submission/)  
* [VLMD Utilities GitHub](https://github.com/HEAL/healdata-utils)

**For Assistance**
___
For assistance with data and metadata submission, please [contact the HEAL Stewards](https://forms.fillout.com/t/gcVveGMswBus).

**Recommended**
___

Review your data management and sharing plan (DMSP) to ensure it is up to date. If any changes have occurred during the award that affect how data is managed or shared, you should update the Plan to reflect the changes. For more information, [click here](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-185.html).


Submit Data and Metadata to a Repository

Once you have submitted your data and data dictionary to a HEAL-compliant repository, they will provide you with a DOI or other unique link to the data in the repository. You need to report that link to the HEAL Data Platform so it can be associated with your study record. If you are submitting multiple collections to a repository OR using multiple repositories, you may have multiple data links to share with us\! Submit your data links by emailing [heal-support@gen3.org](mailto:heal-support@gen3.org). Please include your HEAL Data Platform ID (HDP ID) in the email. To find your HDP ID, follow these [instructions](https://heal.github.io/platform-documentation/reporting-repo/#get-the-permalink-to-your-study). 

Please only share data links that will not change. Some repositories will provide one data link for embargoed data, and a different link after the data becomes public. In this case, please only submit the link that will be accessible after the embargo period ends. 

**Related Links**
___
* [Find and copy your HEAL Data Platform ID (HDP ID)](https://heal.github.io/platform-documentation/reporting-repo/#get-the-permalink-to-your-study)  
* [Reporting your data to the HEAL Platform](https://heal.github.io/platform-documentation/reporting-repo/#reporting-that-data-is-now-available)

**For Assistance**
___
For assistance with submitting a link to your data, please contact the Platform Help Desk at [heal-support@gen3.org](mailto:heal-support@gen3.org).

Report Your Shared Data to the HEAL Data Platform

NIH HEAL Initiative funded investigators are required to make any publications associated with their study publicly accessible immediately upon publication.  


- Manuscript authors must coordinate with journals in advance to pay for immediate open access if the manuscript is published in a journal that is not immediately open access
- Costs associated with ensuring immediate public access of manuscripts upon publication must be included in budget requests  
 
\
**Related Links**
___

- [Submitting to PubMed Central](https://sharing.nih.gov/public-access-policy/submitting-to-pubmed-central)

\
Investigators must alert their program officers of upcoming manuscripts prior to publication to coordinate communication and outreach efforts.



Ensure Public Access to HEAL-funded Publications

Be sure to report your research publication to [HEALquestion@od.nih.gov](mailto:HEALquestion@od.nih.gov) **upon publication** in a journal. Award recipients and their collaborators are required to acknowledge NIH HEAL Initiative support by referencing in the acknowledgement sections of any relevant publication:

\
*This research was supported by the National Institutes of Health through the NIH HEAL Initiative (/) under award number [include specific grant/contract/award number; with NIH grant number(s) in this format: R01GM987654].*

\
**Related Links**
___

- [HEAL-supported Research Publications](https://heal.nih.gov/research/publications)
- [Reporting Publications to NIH](https://sharing.nih.gov/public-access-policy/reporting-publications-to-nih)

\
**Recommended**
___
Review your data management and sharing plan (DMSP) to ensure it is up to date. If any changes have occurred during the award that affect how data is managed or shared, you should update the Plan to reflect the changes. For more information, [click here](https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-185.html).

HEAL Connections is available to support research teams with results dissemination and engagement planning. They offer one-hour consultations at any time in a project’s life cycle. Learn more about their [services and resources here](https://heal.nih.gov/data/connections).




Report Your Research Publication

Fill in this brief survey to provide feedback