Determining the appropriate time to close a study can be trickier than you might think. If you’ve completed your study and all that’s left is writing manuscripts and disseminating your findings, can you close the study in CLARA? How about if you’ve completed all your subject interaction and data collection, but have not finished analyzing your data?
The answer to the first example is yes, you can close the study. You’ve completed all activities involving human subjects or human subject data and you’ve answered your initial research question. All that’s left is to tell the world about what you’ve found. Your project no longer meets the definition of research involving human subjects and you can submit a closure form.
The second example regarding studies still analyzing data is a little more nuanced. If the data being analyzed include any direct identifiers, or any code allowing relinkage to identifiers, your project still meets the definition of research involving human subjects. It’s still research because you’re still figuring out the answer to your research question, and it still involves human subjects because you’re still using private identifiable information. That type of study needs to stay open in CLARA. If the data you’re analyzing have been completely anonymized and there is no way to relink it to individuals, then the study no longer involves human subjects and can be closed in CLARA. It has been our experience that the first scenario happens more often than the latter, because people want to be able to relink data in the event there’s a question about the validity of a particular data point.
Note that once your study activities, including data analysis, are complete, you will likely still retain some identifiable data, in case someone has a question about your publications. You do NOT have to keep a study open for as long as you hang on to these records. You’ve answered your research question and are no longer doing anything involving human subjects.