This is the primer on data entry for the Neuro Oncology Branch BTTC and CERN studies.
Useful site addresses
Manuals for Labmatrix can be found at the bottom of the home page once you've logged in.
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.
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
The notion of a Person 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).
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 Subject record, there will be a gray box near the top of the record with the information about the Person, and then a link within the record that lets you bring up the Person record itself. If you're viewing a Person record, then there's a tab that will list all the Subjects for that one 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.
In order to enter a new subject, click on the "Data Entry" menu at the top of the home page, and then use the "NIH Subject" menu item underneath "Create New". The first step will ask you to enter an MRN, and then you should click "Search" to check to see if there's an existing record for that MRN.
If there is an existing Person record: the record will be opened, with an alert message at the top reading "A single Person record has been found." You should click on the "Subjects" tab to make sure that there isn't already a subject record for this study. If there isn't, just use the "Create New Subject" link a the top right of the record, enter the study name (the correct BTTC or CERN study), and click "Create Subject".
If there is not an existing Person record: the NIH demographics database will be queried, and if the MRN matches a known patient, a new Person record will be created and opened (along with an alert that reads "A new Labmatrix Person record has been created from the NIH Registry"). Now, you can use the "Create New Subject" link at the top right of the record, enter the study name (the correct BTTC or CERN study), and click "Create Subject".
Once you're entering the new Subject record, you need to:
- Enter the subject's custom study ID into the Code field (note that this is critical, since Scribe uses the subject's code to tie Scribe survey responses back to Labmatrix subject records).
- Click on the Forms tab, then the Subject Protocols form in the left-hand column, and then the "Add Subject Protocols..." link near the top of the record; add a new record with the correct BTTC or CERN protocol (remember that those open at the NCI have NCI protocol numbers), along with the protocol start date.
Once you're done entering the subject info, click the "Save" button at the top of the record to save it.
MDASI-BT & MDASI-SP data
At this point, the BTTC and CERN studies are recording just the MDASI-BT and MDASI-SP data in Labmatrix. Both forms are accessible within a subject's record, in the "Forms" tab.
Entering new MDASI data
In order to enter new information, you choose the relevant form from the left-hand column of the "Forms" tab for the correct subject.
- Search for and open the relevant subject record.
Click the "Forms" tab at the top of the record.
From the left-hand column listing of all the relevant custom data forms, choose the correct form (e.g., "MDASI-BT").
Click the "Add <form name>..." link at the top of the record (below the tab bar), and enter the data.
- Repeat steps 3 and 4 for any additional forms that require data entry for this subject.
Click the "Save" button at the top of the record when data entry is complete.
Viewing existing MDASI data
All existing data for subjects is visible within the "Forms" tab of the subject's record.