weave FDA preset runs · comment grading

Grader

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Filters Tick what to include. Counts are the comments each box adds.

Set

Review preset

FDA match

Whether an automated judge matched the comment to FDA's own review. Unmatched comments may still be right.

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Case

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Your grades, one row per comment.

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FDA preset runs

Comment to grade

One AI review comment on the sponsor's text. Click the quoted passage to see it in context on the right.

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Sponsor text

Weave's imported copy, the text the reviewer read. The quoted passage is highlighted.

Choose a document above.

What you are grading

Each case is one comment. Read the comment, open the quoted passage, and answer two questions; the note is optional. Answers save as you make them, and a case counts as complete once you press Save and next; the progress bar and Skip to next unfinished follow that. You can move on without answering and come back later.

Accuracy

Does the comment's claim hold against the sponsor's text, as written? Judge the claim, not the tone.

Holds: The quoted passage says what the comment says it says, and the problem the comment names is real.
Partly: Part of the claim is right, but the comment overstates it, misreads a number or a qualifier, or the sponsor answers the point elsewhere in the same document.
Does not hold: The passage does not support the claim, the comment misreads the text, or the point is answered in the quoted section itself.

Importance

Would an FDA reviewer of this discipline raise this point, and how much would it matter to the review? Score it on a 1 to 5 scale, independently of accuracy: a wrong comment on a central issue still scores high here, and a correct comment on a typo scores low.

5 · Review-defining. A deficiency that would appear in an information request or a review memo's key issues: an unsupported efficacy claim, a missing safety analysis, an exposure margin not addressed.

4 · A reviewer would raise it in writing and expect a response.

3 · Worth a reviewer's note; may be handled at a meeting or in the next round.

2 · Minor. A wording or consistency point a reviewer might mention in passing.

1 · No reviewer would raise it. Cosmetic, redundant, or outside what the review covers.

Notes

Optional, a sentence or two. Most useful when you mark Partly or Does not hold (what is wrong) or score 1 (why a reviewer would skip it). If the sponsor answers the point elsewhere, name the section.

Working through the set

The page opens on the Pre-test set: 20 clinical and 20 statistical comments chosen to spread across sections, dossiers and how much the point would matter if right. The Backup set holds every other comment; tick it in the sidebar filters if you have time for more.
Within a set, cases run document by document, in section order. The sidebar shows how many are complete.
Previous and Next are always free and change nothing. Save and next marks the case complete; Skip to next unfinished jumps past completed cases.
The Progress view lists every case with your answers and lets you jump back to any of them.
Export gives you your own grades as CSV or JSON; the AI team reads the saved grades directly from this page.