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

Useful site addresses

Getting help

Separation of the Person and the Subject

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.