NCI Intramural Investigators Submitting Genomic Data

The following steps are general requirements; please work with your Program Officer, who is responsible to ensure the accuracy of the institutional certification and your designated Genomic Program Administrator (GPA). For general questions, please contact the NCI Office of Data Sharing.

Submission Request Workflow

1. Prepare and Submit a Data Sharing Plan

NCI intramural investigators: Submit your data sharing plan (DSP) with your project proposal.

2. Submit Institutional Certification with Appropriate Signatures to Chief or your division, office, or center (DOC) Genomic Program Administrator (GPA)

The Institutional Certification is the document institutions use to attest that the plans for submitting large-scale human genomic data to NIH meets the expectations of the Genomic Data Sharing (GDS) Policy. Submit your Institutional Certification with the Principal Investigator and the NCI Scientific Director signatures* to the DOC’s GPA.

For a multi-site project (with samples collected at several institutions), either:

• submit a single-site Institutional Certification from each site contributing samples, or
• submit a multi-site Institutional Certification. NIH understands that the submitting institution may not be the local institution or Institutional Review Board of record for all sites. If the submitting institution chooses to submit a multi-site Institutional Certification, the submitting institution agrees to assure NIH that, based on either its own review or assurance from other institutions, the expectations and conditions of the Institutional Certification are met for the entire data set to be deposited.

If disease-specific data use or data-use modifiers are required, please contact the NCI Office of Data Sharing for clarification.

The Institutional Certification assures that projects planning to submit genomic data to NCI/NIH meet the expectations of the GDS Policy. The certification, provided by the submitting investigator and certified by the Institutional Signing Official (SO), must delineate any “data use limitations (DULs)” on the research use of the data, as agreed to in the informed consent documents signed by study participants and identified by the Institutional Review or Privacy Board reviewing the informed consent.

Note: Interpretation must be based on the Institutional Review Board's interpretation of this document:

• Human subjects research—submit research protocol to relevant Institutional GPA
• De-identified human specimens research—submit a request for Office of Human Subjects Research Protections (OHSRP) determination

If disease-specific data use or data-use modifiers are required, please contact the NCI Office of Data Sharing for clarification.

3. Generate Data 

Once data for the full genomic data set have been generated and cleaned, the investigators submit the Basic Study Information form describing the data set to the GPA.

4. Quality Assurance (QA)/Quality Control (QC) Data Before Submission

The submitting investigator performs appropriate QA/QC checks on the data and metadata, then the Principal Investigator Assistant/Submitter uploads appropriate files to the Database of Genotypes and Phenotypes (dbGaP) to obtain a phs accession (obtaining a phs accession number can take up to 4–8 weeks).

5. Complete Full Data and Metadata Submission

• If data are going to the Genomic Data Commons (GDC), then the Principal Investigator/Grantee will need to contact the GDC Help Desk for appropriate submission instructions.
• If data are going to National Center for Biotechnology Information (NCBI) and/or the Cancer Data Service (CDS), then the Principal Investigator/Grantee will follow dbGaP or CDS instructions.

NIH Repositories Data Set Release Expectations

dbGaP/NCI-approved repositories aim to release the data either six months from the date of submission of a full, cleaned, and quality-checked data set, or at the time of first publication (whichever comes first).

NIH/NCI Genomic Data Repositories Help Resources

If you encounter difficulty submitting data to a repository, please contact these help resources directly.

For additional questions about data sharing or submitting data to NCI and NIH Repositories, please contact the NCI Office of Data Sharing.