Study Registration and Data Submission to an NIH-Designated Controlled-Access Data Repository

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When planning to register a study in the NIH database of Genotypes and Phenotypes (dbGaP) and submit human genomic and associated phenotypic data to an NIH-designated controlled-access data repository, please consider the following steps:

  • Contact the appropriate NIH Institute or Center (IC) Genomic Program Administrator (GPA). This step is very important and should be first in the study registration and data submission process. It should occur as early in the process as possible, even during planning, as it helps the NIH IC to prepare for upcoming data submissions, facilitates communications with data repository staff, and identifies special situations that may need to be considered, such as studies with a complicated design or organizational structure.
  • Complete the registration and data submission process electronically in the dbGaP data submission system portal which involves:
    • Providing basic study information (e.g., data types, number of participants).
    • Uploading the Institutional Certification, an assurance that plans for the submission of large-scale human genomic data to the NIH to meet the expectations of the NIH GDS Policy.
    • Uploading the data to the dbGaP submission portal, once the registration is approved and complete.
    • Processing of the data by dbGaP staff.

Please note that the mechanism for data sharing should be consistent with the approved genomic data sharing plan in the funding application and Institutional Certification, which are submitted prior to award. NIH intramural investigators should follow the genomic data sharing plan approved by their IC. NIH Guidance for Investigators in Developing Genomic Data Sharing Plans for NIH-Funded Studies describes the type of information that should be included in a genomic data sharing plan and includes examples of plans.

Related Resources for dbGaP Study Registration and Data Submission