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eRA Information: New Validations and Messages for RPPR

Upgrades to be deployed to the eRA Commons on Wednesday, February 27, 2019and will include new validations in the Human Subjects System (HSS) when submitting Research Performance Progress Reports (RPPR).

New HSS Validations

  • Enrollment and Randomization will be required when submitting an RPPR
  • PI/SOs submitting an RPPR with Studies that are still in Work In Progress status will receive a warning.

 

  Scenario RPPR Response

1.

When application has studies in WIP

Warning message:
The following study(s) <Study Title> have some updated information that have not yet been submitted to NIH. If you would like to provide the latest updated version to NIH, please click on Human subjects link in G.4 and submit the study(s) that are in Work in Progress status.

2.

If Sec 6.6 Enrollment of the First Subject is missing.
Note: This validation is valid only if the CT code of the study is set to 'Yes' and the application was received in FORMS-E format. Ignore Actual/Anticipated value and check if a date is provided

Error Message:
Enrollment of the First Subject date is missing for <Study Title>.Please click on the Human Subjects link in G.4 to update Enrollment of the First Subject date in section 6 of the Human Subjects and Clinical Trials Information form.

3.

If Sec 6.6, 25% of planned enrollment recruited by is missing.
Note: This validation is valid only if the CT code of the study is set to 'Yes' and the application was received in FORMS-E format. Ignore Actual/Anticipated value and check if a date is provided

Error Message:
25% of planned enrollment recruited by date is missing for <Study Title>. Please click on the Human Subjects link in G.4 to update the 25% of planned enrollment recruited by date in section 6 of the Human Subjects and Clinical Trials Information form.

4.

If Sec 6.6, 50% of planned enrollment recruited by is missing.
Note: This validation is valid only if the CT code of the study is set to 'Yes' and the application was received in FORMS-E format. Ignore Actual/Anticipated value and check if a date is provided

Error Message:
50% of planned enrollment recruited by date is missing for <Study Title>. Please click on the Human Subjects link in G.4 to update the 50% of planned enrollment recruited by date in section 6 of the Human Subjects and Clinical Trials Information form.

5.

If Sec 6.6, 75% of planned enrollment recruited by is missing.
Note: This validation is valid only if the CT code of the study is set to 'Yes' and the application was received in FORMS-E format. Ignore Actual/Anticipated value and check if a date is provided

Error Message:
75% of planned enrollment recruited by date is missing for <Study Title>. Please click on the Human Subjects link in G.4 to update the 75% of planned enrollment recruited by date in section 6 of the Human Subjects and Clinical Trials Information form.

6.

If Sec 6.6, 100% of planned enrollment recruited by is missing.
Note: This validation is valid only if the CT code of the study is set to 'Yes' and the application was received in FORMS-E format. Ignore Actual/Anticipated value and check if a date is provided

Error Message:
100% of planned enrollment recruited by date is missing for <Study Title>. Please click on the Human Subjects link in G.4 to update the 100% of planned enrollment recruited by date in section 6 of the Human Subjects and Clinical Trials Information form.