4. Reviewing, Editing, and Submitting a Study

Once a Draft study becomes available for the C(DCC) Administrator to view, the C(DCC) Administrator should review the Draft study information, edit as needed, and submit the study to the Data Hub Data Administrator for review.

4.1. Reviewing a Draft Study

Select the study title from the study table to navigate to the Study Details page, where the C(DCC) Administrator can review and edit the study information.

On the Study Details page, most of the study details will be pre-filled from the dbGaP Registration Form. The C(DCC) Administrator is responsible for reviewing the pre-filled details and providing additional study information in the Study Basic Details section.

4.2. Editing a Draft Study

On the Study Details page, the C(DCC) Administrator must fill in the Study Start Date, Study End Date, Study Subject(s) and Data Collection Method under the Study Basic Details section. Placing the cursor over the question mark will generate a guidance text to help the user provide the appropriate information.

The remainder of the study information will be pre-filled from the dbGaP Registration Form that the Super User has submitted. The C(DCC) Administrator should review this information to ensure the accuracy of data. The C(DCC) Administrator can view the original dbGaP Registration Form by clicking on the “View Study Registration Form” button.

Although the study information will be pre-filled, the C(DCC) Administrator can override those pre-filled values. To edit the data, simply click on the data field to update the values. This direct study metadata edit feature only applies to Draft studies. For other study statuses, users will need to select the “Edit Metadata” button. Scroll down to read instructions on how to edit Submitted, Accepted, and Rejected studies. To save the changes, select the “Save and Continue” button at the bottom of the page or the “Save & Exit” button at the top of the page.

If the C(DCC) Administrator edits any pre-filled study information and saves the changes, an email will be sent to the dbGaP DAR approver, summarizing the changes. The DAR is responsible for updating the study information in dbGaP.

4.3. Adding Data Files to a Draft Study

Continue to the Add Study Data Files page. If you do not have study data files to upload at this time, proceed to the Review & Submit page by selecting the “Continue” button at the bottom of the page. A Draft study can be submitted without data files. When the data files become available, the C(DCC) Administrator can return to the submitted study to upload the data files.

If you have study data files to upload at this time, follow the instructions in the Add Data Files section of the user guide.

Note: The file goes through a CDE validation and PHI/PII validation. If the file passes all validations, the file automatically moves to the Approved status.

4.4. Submitting a Draft Study

On the Review and Submit page, carefully review all the study information on the screen.

If the information is correct, scroll to the confirmation statement, click on the “Agree” checkbox and provide your full name. Select the “Submit Study Data” button to submit your study to the Data Hub Data Administrator for review.

Note: If you have uploaded study data files, the data files will also be submitted with the study. The data files will update from Draft to Pending Approval.

You will be rerouted to the Successful Study Submission Confirmation page where you have the option to navigate back to the My Studies page or print the Confirmation page.

You will also receive a confirmation email in your inbox.

Back on the My Studies page, the status of this study should now appear as Submitted. The study will remain in this status until the Data Hub Data Administrator reviews the study and changes the study status to either Approved or Rejected.

4.5. Editing a Submitted or Accepted Study

The C(DCC) Administrator can edit a Submitted or Approved study. To edit, navigate to the Study Overview tab by selecting the study name from the Home page.

Select the “Edit Metadata” button.

The metadata fields will be unlocked for editing.

After editing the study metadata, select the “Save Changes” button. An email will be sent to the dbGaP DAR approver, summarizing the metadata changes. The DAR is responsible for updating the study metadata in dbGaP.

4.6. Editing a Rejected Study

A study can be rejected by the Data Hub Data Administrator if it contains invalid information or has rejected files.

From the My Studies page, select a rejected study name.

On the Study Overview tab, the C(DCC) Administrator can find the Data Hub Data Administrator’s study rejection comments.

Select the “Edit & Resubmit Study” button.

A pop-up window will appear warning the user that the study’s status will update to Draft, requiring resubmission. Select the “Yes, Continue” button.

Address the Data Hub Data Administrator’s rejection comments by updating the study metadata.

Follow the Draft study Submission process outlined previously to submit the study.

Note: A C(DCC) Administrator cannot submit a study if there are any rejected files. The rejected files must be either deleted or replaced by uploading a new data file with the same file name. The new file that replaces the deleted file will be uploaded as a draft file.