Prospective planning · high severity
The confirmatory study is underway, with milestones, not only on paper
A protocol on paper is not a trial underway. The statute lets FDA require the confirmatory study to be in motion, and failing to conduct it diligently is itself a compliance problem.
The check
Does the outline show the confirmatory study started, with enrolment and a completion date, rather than a protocol that exists?
What the outline has to carry
- a confirmatory study
- underway
- milestones and a date
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 first patient in date, the enrolment target and the target completion date, and name the milestones that will be reported. If the study has not started, say what is blocking it and when enrolment opens.
The source sentence
Simply just having a protocol on paper, it's not the same thing as having a trial underway.FDA Watch, 19:57 to 21:53
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.
Scope and principles
The standard sets the ethical and scientific quality requirements for designing, conducting, recording and reporting studies, applied in proportion to risk.
International · Read the framework
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.