Creating verification and validation study plans
Start a study plan from the Legion Diagnostics verification or validation plan or your own PDF, choose the modules, collect signatures and print it.
A study plan records what you intend to test before the work starts: which analytes, which statistical modules and what design. You find plans under validation and verification.
Starting a plan
Click "New Plan" and pick a starting point:
- Choose "Legion Diagnostics - Verification" to confirm an assay performs to the manufacturer's claims.
- Choose "Legion Diagnostics - Validation" to establish performance for a laboratory-developed test or a new use of an assay.
- Choose "Upload a plan PDF" to use a plan your lab already wrote (PDF only, up to 10 MB).
Then name the plan, say whether the assay is quantitative or qualitative, and pick the analytes from your test directory. For a quantitative plan, you can also mark it as a multi-instrument method comparison.
Older plans written as custom text can still be viewed, printed and signed, but they can no longer be edited. To change one, start a new plan from a Legion Diagnostics plan or an uploaded PDF.
Choosing the modules
The Legion Diagnostics plans start with the usual modules for each kind of study, and you can add or remove any:
- Verification plans start with precision, method comparison, calibration verification and linearity, and reference interval.
- Validation plans start with those four plus limit of blank, limit of quantitation, interference, carryover, factor sensitivity, INR geometric mean and VRI, PT/INR method comparison and manual INR check.
- Qualitative assays start with precision and qualitative method comparison.
You can add multi-instrument method comparison and reagent lot comparison when you need them.
Filling in the design
The plan then asks for general information (operator, reagent, calibrator), a card of design values for each module, and references. Analyzer and analyte details are filled in from the test directory.
A plan with several analytes shows each module as a table, with one row of defaults for all analytes and one row per analyte, where any value can differ. Rows that differ are marked "Custom". Missing required values are counted on each tab, and you can still save and finish them later.
Uploaded plans
For an uploaded plan, Legion Diagnostics reads the study design out of the document and says which modules it found. Data entry then starts from those values. If it cannot find a design, data entry uses the standard design instead, and you can try again. Reading the document uses AI, so when AI is not available to you the design is left for you to fill in.
Signatures and PDFs
Click "Assign Signatures" to ask teammates to sign the plan. Each gets a task in my queue and signs with their own electronic signature.
A signature approves the plan as it stands, so once anyone has signed, the plan can no longer be changed. To change it, every signer must undo their signature, or archive the plan and create a new one.
You can generate a PDF of the plan at any time, and earlier PDFs are kept in its history. Plan PDFs follow your organization's report styling.
From plan to experiment
Click "Create Experiment" to start an experiment from the plan. Its modules' data entry forms then open with the plan's values filled in, for each analyte.