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This is the primer on data entry for the Neuro-Oncology Branch GBM Pembro HSPPC (17-C-0034) study.

Useful site addresses

Labmatrix is a web-based application, and is accessible at the URL https://labmatrix.nci.nih.gov/labmatrix/. Of note, you must use the Firefox web browser, specifically version 45 ESR, in order to access Labmatrix; if you don't have Firefox (or this version) on your computer, you can put in a help desk ticket to have it installed for you. Your login credentials are your central NIH username and password.

Manuals for Labmatrix can be found inside Labmatrix by using the Help link at the upper right, or on the Labmatrix Manuals page (http://go.usa.gov/YPW).

Accessing Labmatrix if you don't have the correct Firefox version on your computer

There are two ways you can access Labmatrix without having Firefox locally-installed on your computer, one if you're on a Windows machine and one if you're on a Mac.

Windows
  1. In a web browser, using Internet Explorer, navigate to https://myapps.nci.nih.gov/.
  2. Click on the "Labmatrix - Firefox" icon, which will launch a virtual instance of the supported version of Firefox and take you to the Labmatrix home page.
Mac
  1. Connect to the NCI Remote Apps server (if unfamiliar with this, navigate to http://remoteapps.nci.nih.gov/ to install the client and learn more).
  2. Once logged in, open Internet Explorer and navigate to https://myapps.nci.nih.gov/.
  3. Click on the "Labmatrix - Firefox" icon, which will launch a virtual instance of the supported version of Firefox and take you to the Labmatrix home page.

Labmatrix Lab Loader

If you are importing clinical labs or cultures, you'll also be using the Labmatrix Lab Loader web application, which lives at https://lmlabs.cancer.gov/; your account information is again the same as your NIH username and password.

Getting help

All assistance with Labmatrix and related tasks should be emailed to:

We have a centralized support system for NCI's Labmatrix installation. Emailing your request means that it is automatically entered into our work tracking system, and doesn't linger in a specific user's inbox; we can also track our responses to issues, and collaborate within our own group in solving problems as they come up. So please submit all requests for assistance via this email address! It's available as a link from Labmatrix's help page, on the login page of Labmatrix, and as a link at the bottom right of the Labmatrix home page.

Separation of the Person and the Subject

 

A critical distinction to understand in Labmatrix is the distinction between a Person and a Subject, a distinction that reflects the difference between a human being's properties (e.g., name, demographics) and the properties related to that human's participation in a study (e.g., the start date of the participation, their custom ID on the study). The distinction allows Labmatrix to enforce access limitations so that study data is only visible to that study's users, yet the general information about NIH patients is visible to the entire NIH community. Below is a simplified diagram showing the relationship of the two; the green area is the Person and associated data, and the yellow area is the Subject and associated data.

Person

The notion of a Person (also known in Labmatrix as a Contact) reflects the information which specifically describes a human being's properties – things such as name, date of birth, gender, race, ethnicity, and medical record numbers. This is the part of the above diagram in the green box; you'll note the small "Race" and "Medical Record Number" boxes, which indicate that a single Person might have more than one of these (e.g., multi-racial, or different MRNs at different institutions).

NIH Patients

The Person records for all NIH patients – e.g., those with NIH Clinical Center medical record numbers – must be placed into the "Patients" access group in Labmatrix! This is because they need to be accessible to all Labmatrix users. Don't worry – nearly 100% of the time, the wizard described below will handle this for you, but I document this just so that everyone knows why this is set up this way.

Subject

The notion of a Subject is what connects a Person to a study – e.g., the Person named "John Doe" is participating on a study named "Cancer Stem Cells", so that Person has a Subject record which links him to the Study. The easiest way to remember this distinction is by remembering that any one human being can participate in more than one study – for example, the person John Doe might be participating in a Derm Branch study, a Radiation Oncology Branch study, and a Surgery Branch study.

There is still only one human being, so there's only one Person record, but there are multiple Subject records linked to that Person which each represent the person enrolled on a specific study. The entire NCI can access that one Person record, but only those people with permissions to access each individual study can access each individual Subject record and the data that's linked to it. (So in the above diagram, each yellow box represents a separate access group, and the data within each is only accessible to those users with the proper permissions on that study.)

In Labmatrix, if you're viewing a Person record, there will be a "Subjects" tab on that record which will show you all the Subjects that you have permissions to see for that Person.

Entering new subjects into Labmatrix

Because of the above distinction, when it's time for you to enter a new subject into Labmatrix, that person might already be in Labmatrix (e.g., they're participating in another study), or a colleague might have already entered their subject info for this specific protocol into Labmatrix. As a result, there's a wizard which helps us avoid duplication that might result from not checking for existing records first, and this wizard is the primary mechanism by which you'll enter your subjects.

In order to enter a new subject, click on the "Subjects" module link in the top row, and then use the "New Subject" link at the top left below the modules bar; this will launch the wizard. The first step will ask you to enter an MRN and choose a study (you'd choose the GBM Pembro HSPPC study from the list of those available to you), and then you click "Search" to check to see if there's an existing record for that MRN on the study. The list will likely come up empty, meaning that nobody has entered this subject yet; there will then be a "Search Persons" button at the bottom of the wizard which will search to see if there is an existing Person record with that MRN (meaning that the person is already in Labmatrix).

If there is an existing Person record: it will come up in the list, and you just highlight the row and click "Create Subject From This Person", which will open a "New Subject" pane pre-populated with the link to the correct Person record.

If there is not an existing Person record: the list will be empty, and there will be a "Search CDR" button at the bottom which will then search the demographics registry for that MRN. So long as it's a valid and correct NIH Clinical Center MRN, clicking this button will bring up the demographics as they're recorded in CRIS for the person; you then just click "Use This Person" at the bottom, and a "New Person" pane will come up pre-populated with all the demographics from the registry. Look these over as a final validation, and then click the "Save" button; this will then bring up a New Subject pane which is pre-populated with the link to the correct (new) Person record.

Once you're entering the new Subject record, there are a few bits of info that you'll enter:

  1. In the "Enrolled Studies" field, choose the GBM Pembro HSPPC study, which will also populate the "Primary Study" field with this study;
  2. Enter the subject's custom ID in the "Custom ID" field (this is important for linking the Scribe data back into Labmatrix);
  3. Click on the "IRB Protocols" tab, and in the "Select IRB Protocol to Assign" pulldown, choose the 17-C-0034 protocol;
  4. Fill in the protocol start date.

Once you're done entering the subject info, click the "Save" button at the bottom of the record to save it.

MDASI-BT data

The GBM Pembro HSPPC study is recording just the MDASI-BT data in Labmatrix. This form is accessible within a subject's record; existing data is present in the "Custom Data" tab within that record, and entry of new data takes place via either Scribe or via the "My Workflows" menu at the top of the record.

Entering new MDASI data

In order to enter new information, you use the "My Workflows" menu that's part of a subject's record.

  1. Search for and retrieve the relevant subject record so that it's visible in the lower-right Workspace pane.
  2. Click the "My Workflows" menu at the top left of the pane.
  3. Within this menu, there's a "17C0034" entry, with the subentry "MDASI-BT". Choose this.
  4. Enter the data, and click "Save" when complete.
  5. Once saved, the new record will appear in the "Custom Data" tab of the subject's record.

Viewing existing MDASI data

All existing data for subjects is visible within the "Custom Data" tab of the subject's record.



Scribe

Scribe is the system used to generate and administer survey sessions for subjects to fill out the MDASI-BT survey online (vs. on paper).

Logging into Scribe

Using any web browser, go to https://scribe.cancer.gov/. Your login is your NIH credentials. Once logged in, you will see a pull-down menu for selection of a survey realm; for this study, the survey realm is 17-C-0034 (GBM Pembro HSPPC).

Creating a new survey session

On the right hand page of the dashboard is the "Create new survey session" dialog box. There, fill in the subject's study participant ID (this is the exact custom ID you entered for them in Labmatrix above) and choose a timepoint on the study. If needed, fill in a comment about the timepoint, and then click the "generate survey session" button.

Once the survey session is generated, you will see a confirmation page. In the middle of the page is a green "Start the surveys now!" button; this is intended to be used if you are sitting with the subject and using a tablet or other device you intend to hand the subject for them to fill the survey out immediately. If this is the case, tap the button and hand the device to the subject.

Otherwise, there is a field at the bottom of the page containing the unique link for this new survey session; copy that link, and then send it to the subject however you might normally communicate with them.

Viewing survey session information

The dashboard shows you all currently-configured survey sessions for the study. By default, the table is sorted by study ID ascending and session creation date descending; you can click (and shift-click) on any of the column headers to re-sort the table, and you can use the "Search" field to immediately filter the table.

Each survey session has a blue "i" icon in the ID column; clicking on this gives you more information about that specific session, and gives you the link to the session.