New Validations for HSS Form When Completing an RPPR

Scenario

RPPR Validation

Study’s inclusion Monitoring code is marked as Yes, but there is no planned enrollment data and the study is not an existing dataset or delayed onset.  

Warning message:

"Planned counts are required to be greater than zero for Inclusion Enrollment Reports <IER#, IER#> under Study<Study#>, Inclusion Enrollment Reports<IER#,IER#> under Study <Study #>. Please click on the Human Subjects link in G.4 to update the Inclusion Enrollment Report(s) in Section 2 of the Human Subjects and Clinical Trials Information form.

Enrollment of first participant was more than 21 days ago, but a Clinicaltrials.gov identifier (NCT) has not been provided.

Warning message:

"Enrollment for <study title> has begun but no Clinicaltrials.gov Identification Number (NCT) has been provided.  Please complete Clinicaltrials.gov registration and use the Human Subjects link in G.4 to add the NCT number in the Human Subjects and Clinical Trial Information Form item 1.5."

The actual Primary Completion Date is more than 12 months ago and results have not been reported to ClinicalTrials.gov.

Warning message:

"The study <study title> Primary Completion date is more than 12 months in the past and results have not been submitted to ClinicalTrials.gov. The responsible party should submit results to Clinicaltrials.gov."

Project level and study level clinical trial codes are discrepant

Warning messages:

When project-level CT code is No:

"One or more study records is listed as a clinical trial; however, this grant has a clinical trial indicator of No. Please contact your NIH Program Officer."

When project-level CT code is Yes:

"None of the study records are listed as clinical trials; however, the grant has a clinical trial indicator of Yes. Please contact your NIH Program Officer.”

Sec 6.  Study Primary Completion Date is missing on the form

Error Message:

Study Primary Completion Date is missing for Study<Study Title>. Please click on the Human Subjects link in G.4 to update the Study Primary Completion Date in section 6 of the Human Subjects and Clinical Trials Information form.

Sec 6.  Study Final Completion Date is missing on the form

Error Message:

Study Final Completion Date is missing for Study<Study Title>. Please click on the Human Subjects link in G.4 to update the Study Final Completion Date in section 6 of the Human Subjects and Clinical Trials Information form.

Sec 6.  Completion of primary endpoint date analyses is missing

Error Message:

Completion of primary endpoint data analyses date is missing for Study<Study Title>. Please click on the Human Subjects link in G.4 to update the Completion of primary endpoint data analyses date in section 6 of the Human Subjects and Clinical Trials Information form.

Sec 6.  Reporting of results in ClinicalTrials.gov is missing.

Error Message:

Reporting of results in ClinicalTrials.gov date is missing for Study<Study Title>. Please click on the Human Subjects link in G.4 to update the Reporting of results in ClinicalTrials.gov date in section 6 of the Human Subjects and Clinical Trials Information Form.

Sec 6.  Is this an applicable clinical trial under FDAAA answer is missing.

Error Message:

Is this an applicable clinical trial under FDAAA answer is missing for Study<Study Title>. Please click on the Human Subjects link in G.4 to update Is this an applicable clinical trial under FDAAA in section 6 of the Human Subjects and Clinical Trials Information Form.

Completion of primary endpoint data analyses date is more than 12 months after the Primary Completion Date

Warning Message:

Completion of Primary endpoint data analyses date cannot be later than 12 months from Primary Completion Date for Study <Study Title>. Please click on the Human Subjects link in G.4 to update the Primary endpoint data analyses date in section 6 of the Human Subjects and Clinical Trials Information Form.

Reporting results in Clinicaltrials.gov date is more than 12 months after the Primary Completion Date

Warning Message:

Reporting of results in Clinicaltrials.gov date cannot be later than 12 months from primary completion date for Study<Study Title>. Please click on the Human Subjects link in G.4 to update the Reporting of results in ClinicalTrials.gov in section 6 of the Human Subjects and Clinical Trials Information Form.