Please review carefully the dbGaP Study Submission Guide (https://www.ncbi.nlm.nih.gov/gap/docs/submissionguide/). Briefly, submission of study data into dbGaP is comprised of two steps: study registration and data submission. Data access occurs only after the data is successfully submitted to dbGaP.
Step 1 - Study Registration. A study must be registered before any study data can be submitted to the dbGaP. Follow these steps to register the study:
- Complete and sign the Institutional Certification appropriate for your project. Forms and instructions can be found here.
- Complete the Data Sharing Plan. See template here.If indicated in (1) or (2) above, obtain proper IRB approval.
- Obtain signature from the Institutional Signing Official (IOS) on the Institutional Certification (in #1 above). For UConn Health, IOS is Dr. Greg Gallo (email@example.com).
- This step will depend on the project. For some, the PI will send the institutional certification and study intake forms directly to the Genomic Program Administrator (GPA). For others, the PI will submit these documents to the the NIH Program Officer (PO), who completes the Data Use Certification (DUC) for each study to reflect the specific study name and desired Acknowledgement Statements. The NIH PO will then provide the PI with a copy of the final “model DUC” to help the PI and the submitting institution’s officials better understand the agreements that secondary users and their institutions must make with NIH to have access to study information through dbGaP. Finally, the NIH PO sends a copy of the DUC to the GPA, who submits these forms to dbGaP.
Step 2 - Data Submission. After the Genomic Program Administrator has verified the Institutional Certification and uploaded the Basic Study Information and DUC into dbGaP, staff from the National Center for Biotechnology Information (NCBI) will contact the PI to discuss the next steps in data deposition.