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Fill an MDR appraisal table

Fill a regulatory appraisal table from a clinical study paper.

Attach a clinical study and your EU MDR appraisal table template, and Anara fills one complete row using only what the paper reports, leaving unreported cells blank. Use it for clinical evaluations where every data point has to defend itself on review.

Prompt

A clinical research scientist at a device company appraises 40 included papers for a CER against a fixed template.

Prompt
I'm filling out a clinical evaluation appraisal table for our EU MDR submission. Attached: one clinical study paper (PDF) and a screenshot of my appraisal table with the column headers and one example row I already completed.

For this paper, fill one complete row of the table using only what this paper reports. Match the format of the example row exactly. If an outcome or data point isn't reported in the paper, leave that cell blank. Do not fill gaps from other sources, from similar studies, or from general clinical knowledge.

For the "Outcomes" column specifically: one bullet per primary outcome, each bullet stating the outcome measure and the reported result verbatim. Include the statistical significance as reported (p-value, 95% CI, or "NS" if stated).

At the bottom of your response, quote the three passages from the paper you used as the main source for the row.

What to add to your library

  • Required: the clinical study paper, attached or from your library.
  • Required: a screenshot or description of your table format, including column headers.
  • Optional: one or two rows you've already completed, so Anara matches your detail and phrasing.

What you get

  • One completed row formatted to match your template, with every cell traceable to the paper.
  • The quoted source passages below the row, so you can verify each data point.
  • Blank cells flagged with a short reason: "not reported" or "not applicable."

Follow-ups

Catch an inferred value.

Prompt
For the "adverse event rate" cell you filled: quote the exact passage from the paper where this is reported. If the paper doesn't report this explicitly and you calculated or inferred it, clear the cell.

Write the discussion paragraph for this paper.

Prompt
Write the discussion paragraph for this paper that pairs with the appraisal row you just filled. Cover what was studied, what was found, and how applicable it is to our device's clinical claim. No speculation beyond what the paper reports.

Tips

  • Restate "use only what this paper reports" every time. Without it, blanks get filled with plausible clinical knowledge, which EU MDR prohibits.
  • Asking for the three source passages makes every row self-auditing.
  • A filled cell that doesn't appear in the quoted passages is the failure mode to catch, most often in secondary outcomes and adverse event counts.