If you are proposing a study that will include both an existing dataset and recruitment of new participants, you should provide separate inclusion forms for the existing dataset and the participants to be prospectively recruited. The existing dataset sample can be provided on the Cumulative Inclusion Enrollment Report. You should provide the sex/gender, race, and ethnicity information only for the data points you will use from the existing dataset or resource. You would provide information for the entire dataset or resource if you were analyzing data from all individuals in that dataset or resource.
The participants to be prospectively recruited should be accounted for on a Planned Enrollment Report with the competing application/proposal and actual recruitment numbers will be reported to the NIH at least annually on the Cumulative Inclusion Enrollment Report.
Have more questions about Inclusion on the basis of sex/gender and race ethnicity? We have more FAQs that can help.