Reporting of Accrual and Demographics

It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. For more information, refer to the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.

Demographic information of participants in clinical research studies should be reported in the Targeted/Planned Enrollment Table, which must be submitted prior to grant award if it was not included in the application. If there are changes in the targeted enrollment, this Table should be updated and the information must be submitted to the NINDS.

To aid the NINDS in fulfilling reporting requirements, the Awardee must complete the Inclusion Enrollment Report Table and the Targeted/Planned Enrollment Table showing cumulative accrual information for each study or clinical trial protocol on an annual basis. In addition, the date for the accrual information should be reported by adding it to this form. This submission should be made as part of the non-competing renewal or annual report. If there are multiple institutions participating in the study (i.e., a multicenter study), the aggregate data should be reported in the table. In multicenter studies that involve domestic and foreign clinical sites, the inclusion data should be reported separately, i.e. as a U.S. total and a foreign total. If the award involves multiple studies (e.g., distinct phase I and phase II components), the table should be completed for each component study. Each time the table is submitted, the Awardee should indicate whether the study is open or closed to participant accrual (and if open, the anticipated accrual closure date), and whether the participant follow-up is ongoing or completed (and if ongoing, the anticipated completion date).