Data Packaging Guidance

A data package consists of data and other files that make the data interpretable and reusable, providing additional context around what the study measured and how the data was collected. It typically includes data files, documentation (such as protocols and data collection instruments), metadata (such as codebooks), and code that documents data collection, organization, and analysis. HEAL studies submit their data packages to HEAL-compliant data repositories for long-term preservation.

As part of the HEAL Initiative, data packages must meet specific sharing requirements:

• De-identify identifiable human subject data prior to sharing
• Include variable-level metadata (VLMD), describing the shared data file(s)
• Provide links to publications generated using study data
• Submit all underlying primary data, making it broadly available in an appropriate data repository

Consult the Checklist for HEAL-Compliant Data and Checklist Tracker Tool to track study progress through HEAL-required data sharing steps. Note: an investigator’s chosen HEAL-compliant repository may have additional repository-specific data packaging requirements.

The HEAL Initiative expects funded studies to “make their HEAL data Findable, Accessible, Interoperable, and Reusable (FAIR) in line with the HEAL Data Sharing Policy and broader efforts across NIH, as outlined in the NIH Strategic Plan for Data Science.” Sharing a FAIR data package enables others to understand, verify, and build upon a team’s work, expanding its impact across the research community. It also allows researchers to combine one study’s findings with other studies or reanalyze the data to generate new insights. By promoting transparency and facilitating reuse, data sharing contributes to scientific progress and innovation.

To learn more about sharing data, please refer to the following HEAL FreshFair Webinars:

• When & What to Share: Understanding HEAL Data Sharing Requirements (Youtube)
• Getting Ready to Share Your Data (Youtube)