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Study closure form options explained

The CLARA closure form has three options for the status of a study that you’re trying to close. The study must fit into one of these three categories to qualify for closure.

“Study never initiated (sponsored studies only)” is appropriate for industry-sponsored trials that, for whatever reason, never got off the ground at this site. If, for example, a multi-site study reaches its overall enrollment goal before the study begins here, the sponsor will likely decide to not open the study at our site, and this option fits those occasions.

“No subjects have been enrolled, no risks have been identified” is for any study that was cleared to begin enrolling but never enrolled any subjects.

“The research is permanently closed to the enrollment of new subjects, all subjects have completed all research related interventions, and collection and analysis of private identifiable information is completed” is the option to select if you have enrolled any subjects at all, regardless of whether the study’s accrual goal was met. This option is appropriate even if all of your subjects were screen failures or the study was terminated early due to the end of funding, safety reasons, or any other reason. If analysis of private identifiable information has not been completed, even though subject interactions are done, the study should remain open.

Other questions elsewhere in the closure form provide additional opportunities to describe why the study is closed and to provide an update regarding study status.