dbGaP

dbGaP Data Submission

This documentation is meant to summarize the procedure for the submission of data to the dbGaP repository. You are encouraged to review the dbGaP Study Submission Guide from NCBI, which covers all aspects of the submission process in detail. This dbGaP Flow Diagram provides a high-level overview of the submission process. The submission of study data into dbGaP is a two-step process: study registration and data submission.

Step 1 - Study Registration

NCBI provides a db GaP Registration Guide, which covers each step of the registration process in detail. A summary of this process is provided below. The study registration process should be initiated by the PI of the study.

1. Identify the appropriate GPA (Genomic Program Administrator) and send the required documentation to the GPA.

Each funding institute or center (IC) has designated staff, referred to as GPAs, who assist researchers with the process of registering a study and submitting genomic data. A list of current GPAs for each funding institute or center can be found here. A GPA is a required part of the registration process. Researchers cannot register a study without using a GPA.

These study registration steps provided here pertain to NIH-funded studies. For non-NIH funded studies, please refer to How to Submit A Non-NIH funded Study to dbGaP for step-by-step instructions.

2. Send the Required Documents and Information to the GPA

Before submitting any data, it is necessary to prepare and obtain an institutional review board (IRB) for a signed Institutional Certification for NIH funded studies. Additional information on completing an Institutional Certification can be found here. You should work on gathering basic study information that will later be entered into dbGaP during registration. A list of standard information gathered at this point in the process is provided below. Some funding institutes/centers (ICs) might require additional information at this stage. These details will be provided by the GPA.

• Target dates for data submission and data release
• Number of participants
• Data type
• Secondary contact information
• Consent groups
• Acknowledgement statement

3. The GPA Registers the Study in dbGaP

Once the basic study information has been received and the Institutional Certifications have been approved, the GPA will start the registration process in the dbGaP system using the PIs name, study name, and grant number (extramural) or protocol number (intramural).

4. The PI receives an "invite" from the dbGaP system

Once the GPA initiates the registration in dbGaP, the PI, or their designated subordinate, may receive an email with instructions for completing the study registration process.

5. PI completes the study registration in dbGaP

The PI, or their designated subordinate, will then enter the basic study information into dbGaP. This information can be updated as needed. The GPA will then upload the signed Institutional Certification and create a Data Use Certification in dbGaP

The Institutional Certification ensures that the study complies with the Genomic Data Sharing (GDS) policy and sets limitations, if any, on how other researchers can use the datasets.

NIH Funded Researches: Should already have completed a signed institutional certification submitted as part of Just In Time Process and prior to the award.

Non-NIH funded Researchers: will need to complete a signed institutional certification to accompany their study submission.

6. GPA verifies the study registration information

Once the GPA verifies the study registration in dbGaP, the PI, or their designated subordinate, will receive an email invitation to the dbGaP submission portal. The registration system then changes the study to "Complete" and locks the study to prevent further changes until the study is released.

Step 2 - Data Submission

Under the NIH GDS policy, large-scale human genomic studies must be registered with dbGaP, but the data can be submitted to dbGaP and/or another repository (e.g. AnVIL), in accordance with the approved GDS plan.

1. Data submission to dbGaP

For researchers who plan to submit data to dbGaP, there is a detailed study submission guide that covers all aspects of the data submission process and includes templates and instructions on how to format data files in preparation for submission

-After submission of metadata to dbGaP, the PI will receive a study accession number and a password-protected preview site to review and approve.

-The dbGaP team will then process and prepare the data.

-For data that will be submitted to a repository other than dbGaP, the study will have a public page on dbGaP with the metadata and provide access control to users, when necessary.

-After the PI approves the preview site, dbGaP will then publish a public display of summary-level data and controlled-access release of individual-level data.

-Studies that have been granted an alternate data sharing plan might not need to submit data to dbGaP, but are still required to register the study in dbGaP.

2. Data submission to a repository other than dbGaP For researchers who plan to submit data to a repository other than dbGaP

-It is still required to register the study with dbGaP.

-It is necessary to submit the associated metadata to dbGaP.