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

Answer

How do I check whether my RWE protocol is ready?

Paste the outline into a checker that reads the text against named checks, then work the findings in order: contradictions first, then what is absent, then what is only partly evidenced. A heading is not evidence. If the outline cannot be quoted for the element a check names, the check is not met. The cheapest sequence is to fix the contradictions (a plan deferred to after lock, an agreement in

Paste the outline into a checker that reads the text against named checks, then work the findings in order: contradictions first, then what is absent, then what is only partly evidenced. A heading is not evidence. If the outline cannot be quoted for the element a check names, the check is not met.

The cheapest sequence is to fix the contradictions (a plan deferred to after lock, an agreement in negotiation), then the absences (no sensitivity analyses, no source verification), then the partly evidenced checks (an external control matched on two variables but not on endpoints or confounding). Each finding should name the rule and the line it read, or it is not checkable.

Where this comes from

The checks behind this answer are on the rule set, each with the timestamp in the recorded source. The legal basis is on the basis page. Run the free check on your own outline.