Read from one recorded source, 19:57 to 39:36/ 29 checks, five families/ Free check, no sign-up
RWE Readiness CheckerA pasted protocol outline, read against the expectations recorded in one FDA Watch episode
C3

Robustness · medium severity

The result is shown to hold across methods, not to depend on one

One method producing one number is a single point. Showing the estimate under the reasonable alternatives is what tells the reviewer whether the conclusion survives a different, defensible choice.

Source: FDA Watch, 31:28 to 32:20. The episode and every citation.

The check

Does the outline show the result will be examined under more than one method or data cut?

What the outline has to carry

  • alternatives
  • consistency

A check is met only when every element above is present. One element on its own is a partly evidenced check, not a pass.

What resolves it

State the primary method, the alternatives that will be run, and the threshold at which the conclusion changes. Report the estimates side by side rather than only the preferred one.

The source sentence

The results are consistent when analyzed in different ways.FDA Watch, 31:28 to 32:20

The quotation is short and is used to show the sentence the rule is read from. The rule itself is our statement, not the speaker's words.

The legal basis

The held frameworks that bear on this check, with the control each one contributes. The link opens the framework page so the reader can check the source.

ICH E6(R3) / ICH-E6-DataMgmt-ExternalData-EHRs-RealWorldData-Coord-FDA-EMA

Data management and external data

A data management plan covers external data, including real-world data, its quality, its traceability and its coordination with the analysis.

International · Read the framework

Try it on your outline. The free check applies this rule and quotes the line it read.

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