How do you define a “study” for the purposes of providing information on the PHS Human Subject and Clinical Trial form and registering in ClinicalTrials.gov?
Our application instructions provide guidance to submit a study record for each protocol. When in doubt, NIH supports lumping several aims or hypotheses into a single study record, to the extent that makes sense for your research.
Have other questions related to the new PHS Human Subject and Clinical Trial form or NIH clinical trial policies? Find more FAQs and their answers at grants.nih.gov.