2. Creating a Study

Every study loaded into the Data Hub must be registered in the dbGaP system first. The study registration process starts when the Principal Investigator (PI) emails the dbGaP Registration Form to the Data Access Request (DAR) approver and the appropriate C(DCC) Administrator. Using the information from the form, the DAR enters the study registration information into dbGaP. Once the study has been successfully registered in dbGaP, the DAR will send the dbGaP Registration Form (PDF file) to the Super User.

The Super User will log in to the Data Hub and upload the dbGaP Registration Form on the Add New Study page. Note that there are several requirements regarding the file’s name.

First, the file name must contain the phs ID. Second, the file name must also contain the C(DCC) program name if the program name was not specified in the “study title” field in the PDF form. For example, an acceptable file name would be “phs001111_covid_study.pdf”.

Once the file has been successfully uploaded, the Super User will select the “Create Study” button. The Data Hub will read the information from the dbGaP Registration Form and automatically create a Draft study.

When the C(DCC) Administrator logs in to the Data Hub, the Draft study will appear on the My Studies page. The Data Hub will also send an email notification to all the C(DCC) Administrators in the C(DCC) Program associated with the study stating the study has been created in the Data Hub and is ready for review.

The C(DCC) Administrator’s access to each study will be granted based on the information provided in the study registration form.

Below is an end-to-end study creation and edit workflow diagram.