A project is a container used to store a dataset. It can be comprised of various health or genomic data for one or many subjects. An account can have one or many projects, and projects can be used to separate datasets for access control or general data-organization purposes.
A Project may also be created within an Account to collect an informed consent from subjects and nothing else, as the PHC is FDA 21 CFR Part 11 compliant.
How to create a new Project:¶
Click the Project name in the upper left corner of the screen to open the drop down menu (it does not matter what project name is showing).
Click See All at the bottom of the Project drop down menu.
Create a Project by clicking Add Project in the top right corner of the screen.
In the dialog box that opens (see image below):
- Name the project. (In the example pictured below, we named our project "Consent Test".)
- Add a description (optional).
- Add a Project Owner email address to override email being sent to the account owner by default (optional). For example, you may want email from a specific project to go to a mailing list of people working on that project instead of the general PHC account owner.
- Check FDA Compliance if you are using the PHC Consent feature to manage 21 CFR Part 11 compliance. If you are using another method to manage consent or if you are using OCR to import medical records with an existing form of consent, you do not need to check this box.
- If you wish to enable Audit Trail click this checkbox. If Audit Trail is enabled, the PHC will begin tracking changes made to the FHIR data within your project.
- Select the appropriate reference build for your genomic data. If your project will not have any genomic data loaded, you can leave the Genome Research Build selection unchanged.
- Enter a Short Name (optional). This is only needed if the regular project name is auto-generated and too long and unwieldy for convenient use.
- Click Add.
To access your new Project, click on the newly created Project via the left-hand navigation or tile in the middle of the screen.
How to access the project configuration page:¶
Click the Project name in the upper left corner of the screen to open the drop down menu.
Hover over the name of the project you want to open the project configuration page for.
Click the gear icon that appears to the right of the project name.
Alternatively, you can click See All on the bottom of the drop down menu and click the gear icon under the name of the project you want to open the project configuration page for.
Audit Trails may be enabled when create a project, or enabled within the project configuration. Once enabled, the PHC will begin tracking changes made to the FHIR data within your project.
How to use the Audit Trail Search¶
The Audit Trail Search is a powerful search engine for finding Audit Events. The search engine supports the boolean operations (
NOT), exact string matching using quotations (
"), wildcard matching using the
Here are a few examples of how to use Audit Trail search:
Search for changes made to Patient FHIR resources
Search for changes made by my user
Search for changes NOT made by my user
Search for all deletions of Patient FHIR resources
delete AND patient
Search for all create or updates made by a user with a lifeomic.com email address.
(create OR update) AND *@lifeomic.com
How to use the Audit Trail Histogram:¶
The Audit Trail Histogram is a tool that allows visualization of when Audit Events have been created over the project's history. The histogram also provides a simple way to filter Audit Events by time. Clicking and dragging on the histogram applies a time filter across the Audit Event data. This filter can be removed by clicking the x on the filter information that appears above the search bar after a time filter has been applied.
How to view changed FHIR data:¶
The FHIR resource referenced by each Audit Event can be viewed in JSON format by clicking the link icon in the JSON Object column of the Audit Trail table. If the Audit Event refers to a resource that was updated, the two versions of the FHIR resource will be displayed side by side. The update can also be viewed in diff format by clicking the toggle in the upper right corner of the screen.