This is the primer on data entry for the Natural History of Lung Cancer protocol (PI: Guha, protocol number: 14-C-0105). In Labmatrix, the study is generally named Thoracic Malignancy Tissue & NatHx.

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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 "Thoracic Malignancy Tissue & NatHx"), 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 "Thoracic Malignancy Tissue & NatHx" study, which will also populate the "Primary Study" field with this study;
  2. If your subjects will have protocol-specific custom IDs, enter this subject's ID in the "Custom ID" field;
  3. Click on the "IRB Protocols" tab, and in the "Select IRB Protocol to Assign" pulldown, choose the "14-C-0105" protocol;
  4. Fill in the protocol-specific information for 14-C-0105 (protocol start date, consent sign date, etc.) as needed.

Once you're done entering the subject info, click the "Save" button at the bottom of the record to save it.

Natural history & tobacco use data

This protocol has two primary data recording forms, the Thoracic Malignancy Patient Info form (for most of the natural history data) and the Tobacco Use Hx form (for the tobacco use data). Both forms are 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 the "My Workflows" menu at the top of the record.

Entry of new natural history or tobacco use 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, choose either "Thoracic Malignancy Patient Info" or "Thoracic Malignancy Tobacco Use", whichever you are entering;
  4. Enter the data, and click "Save" when complete.

Once saved, the new record will appear in the "Custom Data" tab of the subject's record.

Viewing existing natural history or tobacco use data

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

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