External control · medium severity
The sites and countries have a care standard comparable to the reference market
A study can be well run and still not travel. If patients outside the filing market were treated differently, the result may not describe the patients the agency is deciding for.
The check
Does the outline justify that patients at the chosen sites were treated to a standard comparable with the market you are filing in?
What the outline has to carry
- sites or countries
- comparability
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
Name the sites and countries, compare the treatment pathway at each with the reference market, and state how any difference is handled in the analysis or the interpretation.
The source sentence
The standard of care has to be similar to what the standard of care is in the U.S.FDA Watch, 35:10 to 36:02
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.
Sponsor, quality management, monitoring and vendors
The sponsor runs a quality management system, monitors the study in proportion to risk, and oversees any vendor or data partner.
International · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.