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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. 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.

You proceed with the first step of the wizard by entering either the patient's NIH Clinical Center MRN or the MD number (including the "MD" prefix, e.g., MD-11-123) choosing your study ("Molecular Diagnostics"), and then clicking "Search" to allow Labmatrix to search for an existing record on the study with that same identifier. If one doesn't exist, the list below the search fields 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 identifier (CC MRN or SoftPath ID).

NIH Clinical Center MRNs are entered without dashes, whereas SoftPath IDs are entered with dashes. If you make a mistake with this, the wizard should handle it appropriately, but the ideal is to respect these guidelines.

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; the next step will involve pulling the demographic information in from the CDR (our blanket term for the various clinical data registries that contain demographics, such as CRIS and SoftPath). In the "Sync With Registry" field, choose "SoftPath Patient Registry", and in the "Organization" field, choose "Lab of Pathology, NCI", and then click the "Search CDR" button at the bottom. This should 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.

Finally, in the New Subject record, you will want to choose the correct study (again, "Molecular Diagnostics") in the "Enrolled Studies" field. To complete the record, click the "Save" button at the bottom of the window.

Entering Biomaterials for Subjects

The last remaining step is to enter information about the biomaterial. This is done from the Subject record, using the "Create" menu (with the small green plus icon) at the top of the record.

Labmatrix has four biomaterial types, two of which – "Body Fluid" and "Tissue Sample" – are of relevance for the primary biomaterial entry. Pieces of tissue are should be entered with the type "Tissue Sample", whereas fluids should be entered with the type "Body Fluid". And note that bone marrow biopsies are considered tissue samples, and bone marrow aspirates are considered body fluids!

With the Subject window open, click on the "Create" menu, choose the "Biomaterial" option, and then choose either "Body Fluid" or "Tissue Sample" from the submenu. This will bring up a new Biomaterial window, with the source subject pre-entered as the subject from which you created the new specimen.

In the New Biomaterial window, fill in the following fields:

Then click "Save" at the bottom of the window; this saves your primary data, and leaves you with a pane open showing you the new biomaterial. In this pane, again click the "Create" menu (with the small green plus icon), choose the "Custom Data Record(s)" option, and then choose "LMD Case Data" from the submenu – this brings up a new custom data entry window, and is where you enter your lab-specific data about the specimen. In this window, fill in all the relevant fields:

When finished, click "Save" and the data will be attached to the biomaterial record.

Editing the biomaterial's custom data

Editing the custom 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 custom data (vs. editing the entire biomaterial record).

In Labmatrix, when a biomaterial has a single record for a given custom data form (e.g., "LMD Case 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 LMD Case 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 Biomaterial record display – this button edits the entire Biomaterial record (e.g., the biomaterial type, etc.).

Once a biomaterial 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.