You can enter cumulative enrollment of subjects to-date and their distribution by sex/gender and ethnicity/race directly into eSNAP. Two different report forms of the Inclusion Enrollment report are available, and the eSNAP system uses your information to determine which report is viewed.
Note: If activities involving human subjects were performed at any time during the preceding budget period, the population data must be reported in the Inclusion Enrollment section. This applies whether or not the activities are exempt from the Federal regulations for the protection of human subjects and whether or not the activities were performed at either the applicant organization or at any other performance site or collaborating institution.
The 5/01 version presumes that data on sex/gender and ethnicity/race were collected from study subjects using the 1997 OMB standards. These standards require at a minimum that data collection involve two separate questions (one on ethnicity and one on race) and that the question on race must provide the option of selecting more than one race.
The 4/98 version presumes that data on sex/gender and ethnicity/race were collected from study subjects using the 1977 OMB standards. These standards require at a minimum that data collection involve one question on ethnicity and race.
Please review the instructions in PHS 2590 if you have further questions about inclusion enrollment.
The table below describes the fields that are available for you to view or edit in both the 4/98 and 5/01 versions of the inclusion table.
|Inclusion Enrollment Report Table Fields|
|NIH Study Title||The NIH protocol title. This field is display-only.|
|NIH Protocol Number||The NIH protocol number. This field is display-only.|
|Institution Study Title||The study title used by the grantee institution. This field can be edited, with a maximum of 100 characters.|
|Institution Study Number||The study number used by the grantee institution. This field can be edited, with a maximum of 30 characters.|
|Foreign/Domestic Enrollment||A line of text indicating whether the enrolled subjects are foreign or domestic. This field is display-only.|
|Total Enrollment||The total number of subjects in the protocol (the sum of males, females, and unknown for each of the ethnic categories). This field is display-only and changes whenever any of the racial/ethnic fields on the form are updated.|
|Enrollment Comment||Enter any comments and issues to the NIH about enrollment for this study. Issues may include, but are not limited to:
This field can be edited, with a maximum of 2000 characters.
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