Data Freeze Approach
| Definitions | |
| “Data freeze” | A “data freeze” is defined here as a comprehensive database of all “locked datasets” that have been received or prepared by a study’s data management group prior to any associated publications being published. A “data freeze” encompasses data newly generated or updated since the previous repository submission. |
| “Locked datasets” | A “locked dataset” is defined as individual datasets (e.g., specific biomarker assay) or a group of related datasets (e.g., clinical event follow-up files, data files associated with a clinical exam) that have been prepared and are suitable for publication purposes. |
| High publication volume studies | Studies with an average of 25 or more publications per year |
Q: For NHLBI-funded clinical studies, is there an alternative to per-publication sharing for complying with the expectations and requirements of the NIH Data Management and Sharing Policy?
A: To maximize the value of data sharing with the biomedical research community and control study and repository costs, NHLBI allows Institute-supported studies to use a comprehensive data freeze approach to meet NIH Data Management and Sharing policy requirements. This approach requires sharing comprehensive data freezes of scientific data throughout the funded project periods in advance of publications rather than sharing small subsets of extensive data on a per-publication basis.
Q: What are the specific elements of the comprehensive data freeze approach?
A: The specific elements of the comprehensive data freeze approach include the following:
- Throughout the study’s project period, the comprehensive data freezes will incorporate existing datasets (as necessary) and any newly collected or updated versions of datasets that have been locked and made available to study investigators for within-study analyses for the purpose of peer-reviewed publication.
- Data being submitted must be complete and include all scientific data, for example, participant examination data, annual or biannual participant follow-up contact, adjudicated events of clinical significance and vital status, and ancillary study data finalized for analysis whether derived from existing biospecimens, data (genomics, images, clinical data, etc.) or participant contact (questionnaires, wearable devices, remote contact, etc.).
- Submitted data must be accompanied by sufficient documentation (data dictionary in electronic, searchable format; case report forms; protocols and/or procedure manuals) such that investigators unfamiliar with the study have the needed information resources to analyze the data contained within a data freeze release.
- A final, updated comprehensive data freeze will be submitted at or before the end of the project period.
- To meet the reproducibility goals of the NIH Data Management and Sharing Policy, meta-data material from study- and collaborator-initiated, peer-reviewed scientific publications should be submitted as part of an article’s supplemental material or described within the article with sufficient detail to allow for replication. Supplemental meta-data material should reference the study-assigned manuscript number, lead author, title, summary of inclusion and exclusion criteria, list of variables, and summary or code for derived variables.
Q: When should clinical studies using the comprehensive data freeze approach share their data freezes externally and internally?
A: The comprehensive data freeze should be submitted to the repository identified in the study’s approved Data Management and Sharing Plan before any associated publications are published. Consideration should be given to factors such as the timeline for closure of annual follow-up, surveillance for clinical events, and/or typical exam closure dates.
Q: What studies are eligible to propose the comprehensive data freeze approach to fulfill data sharing requirements?
A: NHLBI anticipates research investigative teams to follow the NIH Data Management and Sharing Policy, the NHLBI Supplement to the NIH Policy for Data Management and Sharing, and all other applicable policies and guidance, including requirements on the timing for sharing data.
The NHLBI is making the comprehensive data freeze approach available to all NHLBI-funded studies that have approved Data Sharing and Management Plans specifying comprehensive data freezes. The comprehensive data freeze approach is encouraged for studies anticipating high publication volume.
Q: How should principal investigators of eligible studies propose using the comprehensive data freeze approach to fulfill their data-sharing requirements?
A: Principal investigators of eligible studies who wish to propose using the comprehensive data freeze approach to fulfill their data-sharing requirements should include it in their Data Management and Sharing Plans.
Principal investigators are strongly encouraged to seek guidance from their NHLBI Program Official/Contracting Officer’s Representative in advance of submitting funding applications and new or revised Data Management and Sharing Plans.
Q: Is the comprehensive data freeze approach optional or required for ancillary study data collected from parent studies using the comprehensive data freeze approach?
A: Unless superseded by terms and conditions specified in contracts, Other Transactions (OT), or NIH notices of funding opportunities (NOFOs), ancillary study investigators should follow the data-sharing policies as determined by their parent studies. Therefore, if a parent study uses the comprehensive data freeze approach, so too should its ancillary studies.
Parent Studies: NHLBI expects parent study policies to abide by applicable aspects of the NIH Data Management and Sharing Policy, the NHLBI Supplement to the NIH Policy for Data Management and Sharing, and the NHLBI Comprehensive Data Freeze Approach.
Ancillary Studies: Principal investigators of solicited or unsolicited NIH grants ancillary to parent studies must submit Data Management and Sharing plans consistent with the parent study.
For the purpose of inclusion in each data freeze submission, principal investigators with studies ancillary to parent studies that are using the comprehensive data freeze approach are required to submit finalized data to the respective coordinating centers or the applicable data management groups once locked for analysis.
Each ancillary study Data Management and Sharing Plan must include a provision to submit the scientific data it generates directly to the repository approved for the parent study. This is required because the ancillary study principal investigators will be responsible for submitting data to the repository approved for the parent study in the event the coordinating center or data management group for the parent study is no longer funded and cannot submit the ancillary study data.
Refer to the NIH Data Management and Sharing Policy, NHLBI Supplement to the NIH Policy for Data Management and Sharing, and the NHLBI Ancillary Studies FAQ for more information.