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Separation of the Person and the Subject

Entering new subjects into Labmatrix

Because of the above distinction between Person and Subject records, when it's time for you to enter a new subject into Labmatrix, that subject might already have an existing Person record in our instance – they might be participating in another study, or have had tissue procured in the operating room, for example. As a result, there's a wizard which helps us avoid the duplication that results from not checking for the existing Person record first; this wizard is the primary mechanism by which new subjects are entered into the NCI instance of Labmatrix.

In order to enter a new subject, use the "New Subject" link at the top left of either the Subjects or Contacts module. This will launch the wizard.

Since your subjects are all NIH patients, you proceed with the first step of the wizard by entering the NIH Clinical Center MRN, choosing your study ("GI Cancer Tissue"), and then clicking "Search" to allow Labmatrix to search for an existing record for that MRN on the study. Since there isn't likely to be one, the list will come up empty; 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.

Please enter MRNs into Labmatrix without dashes; this consistency helps us make sure that when we do our regular QA checks for duplicate records, we don't miss any.

If there is an existing Person record: 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-referenced to the correct Person record.

If there is not an existing Person record: If there isn't an existing Person record, then 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 correct demographics 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 it over to make sure it's correct! Finally, click the "Save" button; this will then bring up a New Subject pane which is pre-referenced to the correct (new) Person record.

Finishing the New Subject record

In the New Subject record, you will want to choose the correct study (again, "GI Cancer Tissue") in the "Enrolled Studies" field. If you have a custom ID for the subject (e.g., an ID assigned by the enrollment group or your data management team), then enter it into the "Custom ID" field.

Entering protocol-related information

If you are going to record on-study and off-study dates for your subjects on the study, the relevant IRB Protocol record exists for you to associate with your Subject records. When you're in the New Subject pane, you'll notice that there's an IRB Protocols tab – this is where this information is recorded. First, you have to choose the correct study (as described above), and then clicking on the IRB Protocols tab will bring up a drop-down menu from which you can choose the 11-C-0112 protocol. This will add a row for the protocol, and you can enter the start and end dates here.

After entering this, click "Save" at the bottom of the record, and the subject will be fully entered into Labmatrix.

Entering the subject's visit information

For each visit, you are recording H&P information, as well as prior therapies, current medications, and lab data.

H&P, prior therapies, and current medications

All data but the lab test data is contained in a custom data form designed for your study; it is named "11C0112 Clinical Data", and you enter a new record for a subject by using the "My Workflows" menu on the Subject record.

  1. Open the Subject record so that it's visible in the lower-right Workspace pane.
  2. From the record, click the "My Workflows" menu in the top line.
  3. From this menu, choose "11C0112 Clinical Data".
  4. This will open a new "11C0112 Clinical Data" record in your Workspace pane; enter the data, and then click "Save".

Once saved, the new "11C0112 Clinical Data" record will now appear in the "Custom Data" tab of the Subject's record.

Lab data

Lab data is imported from CRIS into Labmatrix via the Labmatrix Lab Loader.

Editing your custom data

Editing the visit data is as easy as editing the records that were entered above. We include this section in the primer, though, because there is one minor bit of the interface that might prove confusing – choosing which "Edit" button to use to edit the visit data (vs. editing the entire subject record).

In Labmatrix, when a subject has a single record for a given custom data form (e.g., "11C0112 Clinical Data"), viewing that form in the "Custom Data" tab will display the single record in its full-view format. In this format, the way to edit the record is to click the "Edit 11C0112 Clinical Data Record" button at the bottom right of the record's display. This is as opposed to the "Edit" button that's at the top right of the Subject record display – this button edits the entire Subject record (e.g., the protocol enrollment date, etc.).

Once a subject gets more than one record for the custom data form, though, they will then be displayed in tabular format, and it's much easier to edit a single record – you just right-click on the record and choose the "Edit" option from the pop-up menu that's displayed.