These questions are designed to tell whether your study is research-based (requiring IRB approval) or a Program Evaluation/Quality Improvement.
NOTE: After the Project Evaluation (PE) project is complete, the investigators may observe patterns and trends that might contribute to generalizable knowledge. If it is decided at this point to expand the scope of this project by, for example, generating testable hypotheses, then the new project would be research. The investigators could still analyze their PE data as described in the original PE protocol and submit for publication, but any new or additional analyses, with research goals as described in the questions above would be considered research. The investigators would then need to submit an IRB protocol to conduct a research study.