No Inclusion Enrollment Records Provided
When inclusion monitoring is required and no IERs exist, the RPPR system will not allow the submission of the progress report without an IER. An error message will be displayed when you check errors:
"NIH policy requires inclusion to be monitored on Study#<Study#, Study#>, but no Inclusion Enrollment Report(s) have been provided for this study. Please navigate to G.4.b of the RPPR to update this study and provide an Inclusion Enrollment Report"
Warning messages may also display when additional data is expected or when actuals have not been updated in over one year. Those situations and the resulting warning messages are below:
- When the study level inclusion code is Yes, and IERs exist without Cumulative totals (only Planned totals), you should receive a warning message.
- When the study level inclusion code is Yes, and IERs exist with Cumulative totals, but the dataset and actuals have not been updated in the past year (365 days) you should receive a warning message.
“No Cumulative inclusion enrollment data has been provided for the Study#<study#, study#>. Is this correct? If enrollment has not begun, you may proceed and submit the RPPR. If participants have been enrolled, navigate to section G.4.b of the RPPR to update inclusion enrollment report(s) cumulative enrollment data for these studies.”
“Updates to Inclusion enrollment report(s) have not been made for study#<study #, study#>. If updates are needed, navigate to G.4.b of the RPPR to access this study and update inclusion enrollment reports.”