I’m working with an observational time-and-motion study that evaluated process-related parameters (e.g., preparation time, administration time, and time spent in different clinic areas).
Because the study is observational and non-experimental, but does not involve real-world sources such as EMR, claims, registries, or routine practice data, I want to confirm how this type of evidence should be treated in PAAB-regulated materials.
Specifically:
Should this type of time-and-motion study be treated similarly to real-world evidence (RWE) for the purpose of required disclosures, limitations statements, and generalizability notes?
Are there any specific presentation expectations for non-experimental process-measurement studies (e.g., required descriptors of study design, limitations, or other context), distinct from those applied to RWE or retrospective observational research?
I’m not looking to make any clinical-outcome or efficacy/safety claims — just to ensure the correct classification and compliant presentation of this study type.