Some CLARA form questions have been revised with the intent of making them clearer about the information requested.
In the “Subjects” section of the new submission form, questions about enrollment have been revised to read as follows:
How many subjects/charts/specimens do you need to include to be able to complete your study? See help text for guidance.
How many subjects do you need to consent OR charts or specimens do you need to review to find the number of participants in the previous response? See help text for guidance.
The related help text has been revised to provide specific guidance as to how to count the people/records/specimens involved to provide accurate numbers. Remember, these numbers should be updated if your enrollment goal changes during the study.
In the Modification form, the question about whether any subjects are affected by the change has been rewritten to:
Describe how current subjects will be informed of this change. If you will not inform subjects, explain why not. If the response to this question is “n/a,” please explain why it is not applicable.