4. Approving/Rejecting Data Files and Studies
After logging in to the COVID RADx Data Hub application, the Data Hub Data Administrator will land on the Search Studies page, where he will be able to view all the submitted studies.
The Data Hub Data Administrator can use the search bar or filters to identify a specific study or group of studies.
4.1. Reviewing a Submitted Study and its Data Files
On the Search Studies page, select a Submitted study.
You will be taken to the Study Overview tab, where you can review the study’s metadata.
Click on the Data Files tab to review the study’s data files.
Click on the Metadata Files tab to review the study’s data files.
Click on the file name to view the file content in the data file viewer window.
Note: Selecting the export icon will open the data file in a new tab.
The file will open in a pop-up window, where you will have the option to maximize/minimize the screen size so that you can review the contents of the file. For convenience, when viewing a data file in the viewer window, there is an option to adjust the number of rows of the file content.
Note: By default, the file viewer window will display 20 rows of data.
A warning text will appear at the header if the file does not meet PII/PHI or CDE requirements.
If there are multiple data files in a study, the “Previous File” and “Next File” buttons will be available in the footer, to allow easy navigation through the file list.
4.2. CDE and PII/PHI File Validation
The Data Hub will run two types of validations when data files are uploaded to the system: CDE and PII/PHI validation. CDE validation will be performed on harmonized files only (file names ending in …transformcopy.csv). PII validation will be performed on all data files uploaded to the Data Hub.
The CDE validation will check that the harmonized data file contains all the CDE column headers as defined in the global codebook for each program. CDE validation will also check that the data values for each of the Tier 1 CDEs match the predefined values in the global codebook. If the data file is missing any CDE column headers or if any of the data values do not match the expected values, the file will be flagged as non-CDE-compliant.
The Data Hub will also check that all files uploaded to the Data Hub do not contain PII/PHI. If the system detects that the file contains PII/PHI, the data file will be flagged as non-PII/PHI-compliant.
An hourglass icon will appear while the system is running the validation. For files where CDE validation is not applicable, a gray null icon will appear.
If data files are flagged, users can view the CDE and PII/PHI validation analysis by selecting the “View” buttons under the CDE Header, CDE Data, or PII/PHI columns.
CDE Header validation analysis
CDE Data validation analysis
PII/PHI validation analysis
Failed CDE or PII/PHI validations do not prevent the Data Hub Data Administrator from accepting or rejecting a study. They serve as warnings for the Data Hub Data Administrator to review the outputs and decide whether to accept or reject them.
Note: If the file passes all validations, the file automatically moves to the Approved status.
4.3. Accepting or Rejecting Data Files
Scroll to the end of the data files table. Click on the Accept or Reject icons under the “Action” column based on the condition of the file.
Note: Data Hub Data Administrator can also accept or reject a file directly in the file view pop-up window. To open the file viewer, select the file name.
If the Data Hub Data Administrator selects the reject icon, a pop-up window will appear. Select a Reject Code from the provided dropdown and provide additional details in the “Reason for Rejection” optional text field. Select “Save Changes” to confirm the action.
When an action is taken, the Data Hub Data Administrator will get a message confirming that action.
The data file statuses will update to “Approved - Pending Confirmation” or “Rejected - Pending Confirmation” until the Data Hub Data Administrator rejects or accepts the study. Once the study is accepted, the file statuses will change to “Approved” or “Rejected” respectively. If the study is rejected, all the files will change to “Rejected”.
The Data Hub Data Administrator can switch an “Approved - Pending Confirmation” to “Rejected - Pending Confirmation” and vice versa while the data files are in the pending confirmation statuses.
4.4. Confirm File Review
For Approved studies, users can add new Data and Metadata files. These files then can be either automatically moved (all CDE validation pass) to the Approved tab and will be in the Approved status, or users can manually move the files into the Rejected - Pending Confirmation/Approved - Pending Confirmation status. The files in a pending confirmation status will be moved to Rejected/Approved status when the Data Hub Data Administrator clicks the “Confirm File Review” button.
The “Confirm File Review” button doesn’t appear on studies where the study status is Pending Approval or Rejected.
4.5. Approving a Study
To accept a study, all the data files that have been submitted within the study must be reviewed and approved. If the study has been submitted without any data files, the Data Hub Data Administrator can still approve the study. To accept a study, perform the following steps:
Click on the “Approve” button next to the study name to confirm study acceptance.
Click on the “Approve” button in the confirmation pop-up.
Once the action is confirmed, all files will move to the “Approved” status and the Data Hub Data Administrator is no longer able to make any modifications.
4.6. Rejecting a Study
If any of the files are rejected, the entire study can only be rejected. To reject a study, click on the “Reject” button next to the study name.
When rejecting a study, a pop-up window will appear for the Data Hub Data Administrator to explain why the study was rejected. This information will be shared with the C(DCC) Administrator so they can address any issues.
Click on the “Reject Study” button. All the files within the study will be automatically rejected.
Note: When a Data Hub Data Administrator rejects a study, the system automatically updates the status of the study files to “Rejected”, but does not delete the files from the system.
Viewing Comments for Duplicate Files
The Data Hub Data Administrator can also view file version comments under the data files tab within a study
