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Read the literature-search and screening record

Distinguish an issued search protocol, work in progress and the completed account.

Clinical evidence

Where to find it

My Cases → Your case → Clinical evidence

You need

  • A case whose clinical-evidence surface contains a literature record.

Issued search record

This is the plan for your literature review, and a record of the searches your expert has carried out. It is not a statement that the review is complete.

Anything your expert needs from you shows up with your other actions on this case.

Screening under way

Your expert's screening of the published literature for this evaluation is under way. The full account of what was found and screened will appear here once the review is complete.

Completed screening account

These figures are your expert's completed record of the literature screening for this evaluation. Each line is its own count — the lines are not a running total and do not sum.

Sealed conclusion

Once your expert has sealed a conclusion, a third block lists the literature it rests on in three groups, each headed as printed: "Literature included in the review", "Literature taken into the review, not recorded as included", and "Literature not taken into the review". Under the last, the block says plainly: "Your expert did not take these works into the review. What your report records about each of them is on its line." A work whose reference could not be read shows as "A published record (reference unavailable)". A work the report records as unresolved carries, on its own line, "— your report records this work as not fully resolved:" followed by the acquisition state — "the full text is on file", "the full text could not be obtained", "a copy of the full text is still being sought", or "no copy of the full text has been sought".

When a list is withheld

Two lines of the screening account can read as withheld rather than as a number: "No search total was attested for this account — this line is not zero." and "Withheld — your expert is still reconciling duplicate records." And the sealed block can show, instead of its lists, one whole-sentence explanation with a small code beside it — each begins "The literature list is not shown here because…" and ends "Nothing has been lost:" — either "the list reappears once the two agree" or "once your expert has screened that work again" — "and your report itself is unchanged." The code is for your expert; the sentence is for you, and it means the report and the case's current screening record do not yet describe the same review.

What happens next

  • Use the case's action rows for anything the expert needs from you.
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Official references

This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.

European Commission — Medical Devices: New regulationsRegulation (EU) 2017/745 — Medical Device RegulationRegulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices