If the applicable clinical trial has reached the primary completion date (ie, completed data collection for the primary endpoint/outcome measure) whatever the time frame, results of must be submitted by the Responsible Party no later than 12 months after the primary completion date. If the applicable clinical trial is investigating mortality over a long period of time (eg, 10 years) and the investigator chooses to analyze mortality trends over time during the course of the study, the outcome measures may be revised according to the desired analysis timeframe while the study is still ongoing. If, in this example, the only primary outcome measure is mortality at 10 years and the investigator does not choose to analyze the data prior to the primary completion date, the study will still be considered ongoing. The record, however, should be updated regularly to accommodate for enrollment status and protocol/amendment verification.
