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This is the primer on data entry for the POB Psychology ACT study.

General Information

Useful site addresses

Labmatrix is a web-based application, and is accessible at the URL https://labmatrix.nci.nih.gov/labmatrix/. Your login credentials are your central NIH username and password.

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.

Getting help

All assistance with Labmatrix and related tasks should be emailed to: ncilabmatrixhelp@mail.nih.gov.

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 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).

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 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 (ACT), 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 (ACT), and click "Create Subject".

Once you're entering the new Subject record, you will want 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). Once you're done entering the subject info, click the "Save" button at the top of the record to save it.

ACT survey data

All ACT study survey data will be entered and viewed in the "Forms" tab within a subject's record, and entry of new data takes place by clicking the "Edit" button at the top of the record, then selecting a form from the left-hand column, and then clicking the "Add <form name>..." link near the top of the record.

Entering new ACT survey data

In order to enter new information, just use the relevant form from the left-hand column of the "Forms" tab for the correct subject.

  1. Search for and retrieve the relevant subject record so that it's open.
  2. Click the "Forms" tab at the top of the record.
  3. From the left-hand column listing of all the relevant custom data forms, choose the one for which you're entering data.
  4. Click the "Add <form name>..." link at the top of the record, below the tab bar, and enter the data.
  5. Repeat steps 3 and 4 for any other forms for which you need to enter data for this same subject.
  6. Click the "Save" button at the top of the record when data entry is complete.

Viewing existing ACT data

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

Using Scribe to collect ACT survey data

Scribe is the web-based tool that allows study subjects to provide answers to the PROM surveys online.

Creating a survey session for a subject

A survey session is a batch of individual surveys which a subject needs to fill out at a single timepoint. A member of the study team configures the session, and then either sends a link to the subject via email, or has the subject fill out the surveys on a tablet (e.g., while in clinic). To configure the session, follow these steps:

  1. Go to the Scribe website (https://scribe.cancer.gov/) and log in.
  2. From the Realms menu, choose "ACT"; this will bring up your study dashboard.
  3. On the dashboard, fill in the subject and timepoint information in the "Create new survey session" section on the right, and click the "generate new survey session" button.
  4. The next page will show you a link that you can cut and paste into an email to the study subject; it also has a large green button which you can use to start the survey session immediately (e.g., if you are following these steps on a tablet in clinic, and want to hand the tablet directly to the subject so they can fill out the surveys at that time).

Once a survey session is created, it will be listed in the Survey Sessions table on the study dashboard. Each session has a small blue "i" icon next to it; clicking this icon will show you details about the session (e.g., the timepoint), and also contains the unique link to the session. (If you find you need to copy this link, for example to re-send to a subject, you can right-click it and copy it.)

Moving Scribe data into Labmatrix

So long as there's an ACT subject in Labmatrix with the subject code used to configure a survey session, the session will be automatically imported into Labmatrix within 30 minutes of the subject confirming its completion.

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