Prospective planning · high severity
The protocol is pre-specified and shared with FDA before the study starts
A protocol written before the data exists is the difference between a study and a search for a result. Reviewers read a plan that arrives after the data as a plan shaped by what the data showed.
The check
Does the outline say the protocol was shared with the review division before the study was conducted?
What the outline has to carry
- a protocol
- prospective timing
- FDA engagement
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 date the protocol was shared, the meeting or submission it went through, and the review division. If it has not been shared, say when it will be and what is still open.
The source sentence
FDA recommends sharing your protocol and statistical analysis plan before the real-world study is conducted.FDA Watch, 29:46 to 30:36
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.
Protocol and study reporting
The protocol states the objectives, design, population, endpoints, analysis and reporting before the study begins.
International · Read the framework
Compliance with the protocol and good clinical practice
The sponsor and investigator conduct the trial in accordance with the protocol and with good clinical practice.
European Union · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.