Submitting Inclusion Enrollment Reports for Clinical Research
You can enter cumulative enrollment of subjects to-date and their distribution by sex/gender, race, and ethnicity directly into RPPR. Two different report forms of the Inclusion Enrollment report are available, and the RPPR 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 Inclusion Enrollment Report presumes that data on sex/gender, race, and ethnicity 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 of the enrollment report presumes that data on sex/gender, race, and ethnicity 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. Very few studies should still be using these standards.
If you have questions about what enrollment format to use, please contact your program officer.
Please review the instructions in RPPR if you have further questions about inclusion enrollment.
- Open the RPPR Menu page for the desired grant (see Querying Progress Reports for details).
- Select Edit | G Special Reporting Req, question G.4.b Inclusion Enrollment Data to review your inclusion enrollment obligations. Hyperlinks are provided to the required reports.
- Click the hyperlink to open the Inclusion Enrollment Report Table page.
- Complete the required information and click Submit to update your information.
The table below describes the fields that are available for you to view or edit in both versions of the inclusion table.
Inclusion Enrollment Report Table Fields |
Field Name |
Description |
|
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:
- Explaining why there is either no enrollment or limited progress in enrollment.
- Explaining any problems encountered when subjects are asked to provide information on sex/gender or race/ethnicity.
- Describing sub-populations that have implications for the research questions you are studying.
- Describing if the study is closed for further enrollment.
Also for NIH-defined Phase III studies, use the Enrollment Comment to indicate if data analysis has begun and, if so, if progress has been made in conducting analyses for sex/gender, racial, and/or ethnic differences.
This field can be edited, with a maximum of 2000 characters. |
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