Data Sharing and Management

Photo Credit: UCLA Broad Stem Cell Research Center

CIRM Data Explorer

Data Explorer was established to maximize the value of CIRM-funded stem cell and genetic research by making datasets findable and accessible, thereby enabling reuse of data by other researchers. 

Data Explorer is:

  • A public dashboard of CIRM-funded datasets and where they can be found
  • A platform for CIRM awardees to submit a Data Sharing and Management Plan (DSMP)
Launch Data Explorer

Discovery, Preclinical, and Clinical Program Requirements

The sharing of data and knowledge produced from CIRM-funded projects is key to advancing the field of regenerative medicine and accelerating the discovery, validation and development of treatments for patients. CIRM requires awardees to manage and preserve raw data, processed data, and metadata, and make Applicable Data and metadata available to the broader scientific community. CIRM also requires applicants to allocate funds in their proposed budget for personnel and/or activities related to managing and sharing data produced from the funded project. To ensure data processing steps can be replicated and data can be reused by other researchers, CIRM requires sharing of data in accordance with FAIR and CARE data principles, using established repositories where possible. CIRM requires that applicants provide a Data Sharing Overview in their proposal, and awardees develop and execute a detailed Data Sharing and Management Plan (DSMP). The data repositories selected and other information about deposited data must be reported to CIRM during and after the project period. To promote FAIR data sharing and open science, CIRM will publicly share information about CIRM-funded data, in the Data Explorer dashboard, including what types of data were generated and where data are deposited. All application, awarded project, and active award requirements described here are incorporated by reference in Program Announcements and Requests for Applications which reference this resource. These requirements apply to all DISC awards made after December 31, 2022 and all Discovery, Preclinical, and Clinical awards made after January 1, 2026.
As part of a Proposal, applicants must provide a general, high-level plan for sharing data produced in the proposed project, the Data Sharing Overview. Applicants must allocate funds in their proposed budget for personnel and/or activities related to managing and sharing data produced from the funded project. For guidelines, please refer to the Data Sharing Budget Justification Guidelines. Instructions for completing the Data Sharing Overview are provided in the application.
If a project is awarded, a DSMP must be submitted to CIRM as Just in Time (JIT) material during Pre-Funding Administrative Review (PFAR). CIRM will review DSMPs and work with awardees to optimize the DSMP, including negotiation of milestones and budget. Awardees must agree with CIRM on a DSMP and associated milestones and budget prior to CIRM issuing a Notice of Award. Please consult CIRM Data Sharing and Management Plan (DSMP) Guidelines for the purpose and scope of the CIRM DSMP, data terminology, and instructions for submitting a DSMP to CIRM and updating it throughout the duration of the award.

Grantees will report on their data sharing and management activities during regularly scheduled progress reporting and will work with CIRM staff to adjust the DSMP and other data-related milestones as necessary and align data sharing processes with other initiatives at CIRM.

In addition to data sharing, CIRM expects that knowledge resulting from PDEV awards will be shared within the CIRM network to drive efficiency and reduce potential roadblocks by leveraging proven processes, study designs, and regulatory pathways to optimize development and eliminate redundant efforts. Sharing learnings with other CIRM awardees will improve product development progression and support a risk-based approach to both planned and unexpected changes throughout the preclinical drug development process while retaining IP and patient/donor privacy. PDEV awardees are asked in the Data Sharing Overview section of the application to certify to work with CIRM to align with knowledge sharing processes as they are implemented.

CIRM recognizes the balance between protecting intellectual property prior to commercialization and CIRM’s commitment to open science and innovation, and as such there may be Applicable Data generated as part of PDEV awards which could be treated as confidential until filing for patent protection, as trade secrets with requisite enhanced company protection, or in advance of regulatory approval. Data and knowledge sharing will be maximized to the extent that is possible.

CIRM stipulates that clinical trials funded by CIRM in whole or in part are required to share completed study results with the scientific community. In addition to submitting a DSMP and submitting Applicable Data to repositories (see CIRM Data Sharing and Management Plan (DSMP) Guidelines, the following requirements apply to Clinical awardees to facilitate clinical trial data sharing:
  • The trial must be registered at ClinicalTrials.gov no later than 21 calendar days after the enrollment of the first participant.
  • The informed consent documents for the trial must include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov
  • The responsible entity must update the clinical trial record at least once every 12 months
  • The trial results must be submitted to ClinicalTrials.gov 12 months from the Primary Completion Date.

Data Sharing Expectations Per Program and Award Stage

This table outlines the different data sharing steps at Application, Just-in-Time, Active Award, Award End, and Post Award stages for Discovery, Preclinical Development, and Clinical Development Programs. Resources are provided for each step:

Stage
Requirement
Resource
Discovery
Preclinical Development
Clinical Development
Application

Data Sharing Overview
CIRM DSMP Guidelines
X
X
X
Budget Justification
Budget Justification Guidelines
X
X
X
JIT/PFAR
Data Sharing and Management Plan (DSMP)
Instructions in CIRM Data Explorer
X
X
X
Register data sharing statement on ClinicalTrials.gov
clinicaltrials.gov
X
Award
Update DSMP
Instructions in CIRM Data Explorer
X
X
X
Informed consent documents include data sharing language, if necessary
CIRM Guidance for Data Repositories and other Resources
X
X
X
Clinical trial record is updated at least every 12 months
clinicaltrials.gov
X
Award End

Deposit data in appropriate repository
CIRM Guidance for Data Repositories and other Resources
X
X
X
Submit final DSMP
Instructions in CIRM Data Explorer
X
X
X
Post Award
Results submitted to ClinicalTrials.gov 12 months from Primary Completion Date
clinicaltrials.gov
X

CIRM Data Sharing and Management Plan (DSMP) Guidelines

Funded awards only

Purpose of the DSMP

To leverage CIRM-funded data and enable reuse of data by other researchers, CIRM awardees are expected to share their data consistent with FAIR (Findable, Accessible, Interoperable, and Reusable) and CARE (Collective Benefit, Authority to Control, Responsibility, and Ethics) data principles and reflective of practices within specific research communities. Development and execution of the CIRM Data Sharing and Management Plan (DSMP) is intended to facilitate:

  • Findability of data through a public dashboard, the CIRM Data Explorer
  • Accessibility of data by deposition in data repositories accessible to other researchers
  • Interoperability, and
  • Reusability of data by associating deposited data with necessary and sufficient metadata.

Scope of the DSMP

CIRM requires DISC, PDEV, and CLIN2 awardees to manage and preserve raw data, processed data and metadata, and share Applicable Data and metadata, i.e. make Applicable Data and metadata available to the broader scientific community through data repositories accessible to other researchers. CIRM expects all Applicable Data generated under CIRM DISC and PDEV awards to be shared no later than the time of publication or by the end of the award period, whichever comes first. CIRM expects clinical trial data and results generated under a CLIN2 award to be shared no later than 12 months after the study’s Primary Completion Date. Even data not used to support a publication, including null or negative findings, are considered data.

For some programs and data types, CIRM has developed specific data sharing expectations (e.g., data types to share, relevant standards, repository selection, timelines) that should be reflected in a DSMP. When no specific CIRM data sharing expectations apply, researchers should propose their own approaches to data sharing and management.

CIRM requires that anyone deriving data from living humans must be prepared to ensure privacy and confidentiality protections (i.e., de-identification, Certificates of Confidentiality, and other protective measures), in accordance with applicable federal, Tribal, state, and local laws and regulations.

Instructions for Submitting and Updating DSMP

The CIRM DSMP has 3 components:

  • Metadata Catalog
  • Data Use Limitations (DUL) Institutional Certification
  • Questionnaire

Together, these components outline how the data for the funded project will be shared with the scientific community.

For all data you propose to generate, please prepare a Data Sharing and Management Plan (DSMP):

  1. Join/log into CIRM Data Explorer
  2. Complete the Metadata Catalog for expected data
  3. Complete, sign, and submit the Data Use Limitations (DUL) Institutional Certification form
  4. Complete the DSMP Questionnaire

The Metadata Catalog will be a living record:

  • Initial Metadata Catalog: Prior to CIRM issuing the Notice of Award (NoA), the initial Metadata Catalog is submitted to CIRM. It contains minimal information about the anticipated data types and experimental design of the project.
  • In progress Metadata Catalog: Throughout the project, the Metadata Catalog is continually updated as data are produced and metadata are collected. This ensures timely and progressive assembly of all information necessary for data deposition at the end of the project. The Metadata Catalog must be updated as part of each scientific progress report and is subject to CIRM review and approval.
  • Final Metadata Catalog: At the end of the award, the Metadata Catalog, as well as the DUL form are finalized and together these documents serve as a record of metadata that is shared with the corresponding raw and processed data.

Once data have been deposited by the awardee, the metadata provided in the Metadata Catalog and the DUL information will be made public and displayed in the CIRM Data Explorer, a dashboard that scientists can use to discover CIRM-funded data and determine where they are deposited.

Data Terminology

  • All data that are needed for another researcher to replicate results and to reuse data. Minimally this includes raw data, final processed data and metadata.
  • CIRM does not anticipate that researchers will preserve and share all data produced in a study. Researchers should decide which data to preserve and share based on ethical, legal, and technical factors that may affect the extent to which data are preserved and shared. The rationale for these decisions must be provided in the DSMP Questionnaire.
  • Data not used to support a publication, including null or negative findings, are also considered Applicable Data.

The Intellectual Property Policy for CIRM Awards defines “Data” as: Scientific, clinical, or technical recorded information derived during the Project Period of an Award, regardless of form or the media on which it may be recorded, but not any of the following: financial, administrative, management data, other information incidental to contract administration, preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. “Data” excludes physical objects (e.g., laboratory samples).

Generation of raw data

All data processing steps (dry lab) following generation of raw data

Overarching term, referring to both data generation and data processing

The result of each data generation step and each data processing step (Each data product should be listed in the DSMP Metadata Catalog)

Data produced by an instrument (e.g., raw sequence data) or by other methods, such as measurements and surveys, or obtained from a data repository

Data produced from raw data and from subsequent processing steps (e.g., quantification files, alignment files, etc.)

Data produced from last processing step (e.g., aggregated quantification, etc.), on which conclusions are based

Data that provide additional information needed to make shared raw and processed data findable, interpretable and reusable. Metadata information is requested in the DSMP.

Metadata categories in CIRM Data Explorer

  • Data Product Details: methods used for data generation (machine, instrument), data processing (software toolkits, pipelines) and data sharing (data repositories).
  • Biological Material Details: information about the source and modifications of the biospecimens and the final cell product used for data generation
  • Goal of Experiment: information about diseases studied and/or biological questions addressed
  • Sample Preparation: information about experimental approaches used to prepare the sample for data generation
  • Protocols and Publications

Guidelines or formal rules for producing, structuring, naming, and describing data. CIRM expects that an awardee will apply data standards that are common to their field of study in the production of data and to metadata that are deposited in a Data Repository. Examples of data standards can be found at CDISC or LOINC.

Making data available to the broader scientific community by depositing in a data repository accessible to other researchers

For clinical trials, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated

Another researcher uses shared data and same code/software as original researcher to obtain the same results

Another researcher uses shared data and different tools / software to obtain new results, or uses shared data in combination with their own data

Applicant and Awardee Resources

Data Sharing FAQ [Coming Soon]
CIRM Data Explorer Walkthrough Videos

CIRM Guidance for Data Repositories and other Resources

This document provides a non-comprehensive set of resources for identifying and selecting domain-specific or generalist data sharing repositories for discovery, preclinical, and clinical data. Researchers are advised to reference the repository policies.

Springer Nature Data Repository Guidance

This resource provides listing and guidance on specialized and generalist repositories. The specialized repositories are categorized by scientific discipline or data types and the notes include suggestions or recommendations for repository selection. The listing also includes links to the repository entry on FAIRsharing.org where researchers can obtain more information on the repositories.

  • Scientific Data mandates authors submit datasets to an appropriate public data repository. 

NIH Data Resources

The NIH maintains a non-comprehensive listing of NIH-supported domain-specific data repositories as well a list of external generalist repositories. The lists are organized as tables and include descriptions as well as links to data submission and data access policies.

Repository Search Tools

  • Fairsharing.org—A community driven resource that promotes FAIR principles by providing a searchable database of repository profiles, data standards, and journal and funding sharing policies.

External Resources Related to Sharing Protected Health Information (PHI)

CIRM Data Sharing and Management Budget Justification Guidelines

Applicants should consider and justify any resources needed to adhere to their plans for data sharing and management, as described in the Data Sharing Overview in the application, and as anticipated in their more detailed Data Sharing and Management Plans (DSMPs) which will be submitted to and negotiated with CIRM prior to issuance of a Notice of Award (NOA), if awarded. For more information on data sharing and management requirements, please see the Discovery, Preclinical, and Clinical Program Requirements section. Costs required for implementing the DSMP must be requested and justified in the submitted application as part of the overall Budget Justification for the project and incurred during the funded project period. Consistent with CIRM’s Grants Administration policy (GAP) for Discovery, Translation, and Education Projects and CIRM’s GAP for Clinical Stage Projects, budget requests must not include infrastructure costs that are included in institutional overhead (e.g., awardee’s facilities and indirect costs) or costs associated with the routine conduct of research. Costs associated with collecting or otherwise gaining access to research data (e.g., data access fees) are considered costs of doing research and should not be included in data management and sharing budgets. Costs may not be double charged or inconsistently charged as both direct and indirect costs. Reasonable, allowable costs for managing and sharing data may be included in CIRM budget requests. Resources to cover total cost of data sharing or adhering to the DSMP do not solely have to be funded by CIRM.
  • Curating data and developing supporting documentation, including formatting data according to accepted community standards; de-identifying data; preparing metadata to foster discoverability, interpretation, and reuse; and formatting data for transmission to and storage at a selected repository for long-term preservation and access
  • Local data management considerations, such as unique and specialized information infrastructure (only those not covered by awardee’s facilities and indirect costs), necessary to provide local management and preservation (e.g., before deposit into an established repository)
  • Preserving and sharing data through established repositories, such as data deposit fees necessary for making data available and accessible. For example, if a data sharing plan proposes preserving and sharing data for 10 years in an established repository with a deposition fee, the cost for the entire 10-year period must be paid prior to the end of the project period. If the data sharing plan proposes deposition to multiple repositories, costs associated with each proposed repository may be included.
  • Personnel costs required to perform data management and sharing activities. Provide effort, annual salary and personnel cost for this project.