List of available reports in iRIS
| Available reports | Description | Format |
| Accrual per IC - (CSV) | This report pulls "Total Enrollment" and "Aggregate Total Accrued" from latest Continuing Review Submission. | CSV |
| Adverse Event Report (NIH Problem Form) - PDF | This report lists most recently submitted Adverse Events from NIH problem form for the selected protocol | |
| Adverse Event Report per IC (NIH Problem Form) - (CSV) | This report lists most recently submitted Adverse Event(s) from NIH problem form. (Either Board or Team select "SAE" in the form). It displays results per IC, which is taken in as a parameter, along with submission date ranges. | CSV |
| Approved Amendment(s), CR(s) and Study Status Change(s) per Study - (CSV) | This report includes selected Study's approved Amendment(s), Continuing Review(s) and Study Status Change(s) type requests. | CSV |
| Deviation Report (Reportable Events Submission Form) - PDF | This report lists most recently submitted deviations, Unanticipated, and compliances from NIH problem form. Excludes any records indicated as Adverse Events | |
| Expedited Actions by Approval Category (CSV) | This Report lists all Expedited Actions by Approval Category | CSV |
| Expedited Actions Report - (PDF) | This report pulls all the forms that are listed on the IRB Agenda under the Expedited Action category and Investigation Brochure category. Risk assessments are pulled from the reviewer's checklist. | |
| GDS - Reporting | This report pulls the GDS policy apply information and category from latest created/revised study application. | CSV |
| Initial and Amendment Submissions Per IC (CSV) | This report brings initial and amendment submissions submitted between selected date range for selected IC | CSV |
| Initial and Amendment Submissions Per Protocol (CSV) | This report brings initial and amendment submissions submitted between selected date range for selected protocol | CSV |
| KSP Training - Study Institute (CSV) | This report lists the KSP Training Records for the Studies which have a Default Branch that belongs to the Selected Institute. Note that it only includes the KSP from section 3 of the Study Application. Studies with Status Closed, Terminated or Withdrawn are excluded. | CSV |
| KSP Training - Select Study (CSV) | This report lists the KSP Training Records for the Selected Study. Note that it only includes the KSP from section 3 of the Study Application. Studies with Status Closed, Terminated or Withdrawn are excluded. | CSV |
| List of Deviation(s), UP(s) and Non-compliance(s) per IC - (CSV) | This report pulls non-AE problem form submissions by selected IC and for a selected date range to improve query speed | CSV |
| List of Deviation(s), UP(s) and Non-compliance(s) per Protocol - (PDF) | This report lists all the deviations (combined both forms),Unanticipated, and Non-compliance in selected protocol | |
| List of Studies by Institute (CSV) | Lists all studies for a chosen institute including IRB #,short title, PI name, PI institute/branch, the responsible IRB panel, and the current protocol status. | CSV |
| Multicenter Trials and Site information - Study Application (CSV) | This report includes studies only if Multiple Sites is selected for Enrollment Site in the latest created/revised study application. It runs at the protocol level | CSV |
| NHLBI Study List - (CSV) | NHLBI protocols list for Clinical Directors. | CSV |
| Outside IRB's per IC (CSV) | This report pulls the IRB of record for protocols marked as having a non-NIH reviewing IRB | CSV |
| Outstanding Internal Submission Routing (CSV) | This report gives list of outstanding Internal Submission Routing. | CSV |
| Outstanding Submissions Per PI/IC (CSV) | This report lists the outstanding submissions for studies using IC and PI as parameters | CSV |
| Participating Sites per IC (CSV) | For the IC selected, this report lists participating site information if multiple sites is specified on the study application, along with the latest reviewed submissions for that site from the form "Outside IRB Documents for Multi-Institutional Trials" | CSV |
| Project Number Study Information | This report includes P Number protocols only (Draft Status and Pending). The data fields are pulled from latest created/revised study application. | CSV |
| Protocol/IND Info per IC (CSV) | This report pulls general protocol info along with IND info for the chosen institute | CSV |
| Reportable Events per IC (NIH Problem Form) - (CSV) | This report lists all the problems that are submitted within the selected date range per Institute. | CSV |
| SMC Review Protocols per IC (CSV) | This report pulls DSMB/SMC info, taking in IC as a parameter. It uses continuing review form for date of last SMC Review field. | CSV |
| Studies by PI | This report pulls protocol info for studies of the chosen PI | CSV |
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