Please note: A PDF version of this guide is available for download at the bottom of the article.

This manual takes you through the reports that are available through IRB Assistant. Reports are listed in this document, with a summary of what the report pulls. Reports are available within the IRB Assistant menu item, Reports. Reports can be built using the Report Builder, but the reports discussed here are the pre-canned Reports that come with the IRB Assistant module.

Running Reports

The Reports page lists the available reports grouped into a variety of categories. Clicking on a report link will allow you to set specific parameters and run the report. The parameters and filter options for each report will vary based on the requested information.

Within each report you will have the option to display the report in PDF, HTML, and Excel format.

When you click the Helpful Information button the Report Generation Help window will populate. The window displays notes that assist you in running the report and also displays the description of the report.  

IRB Reports

The following portion of this document lists out the different report groups and the reports within each group, explaining the report filters and what information the report pulls. Your list of reports may or may not contain the same list, depending on your configuration.

Amendments Given Expedited

Turn Around Time Submissions

This report runs a count on the number of submissions received, processed, and returned. The report analyzes the time in days it takes to turn the submissions around. You have the ability to modify the report filters by changing the start and end date.

Click the button to generate the results. The category description table is as follows:

The category description table gives information about the included elements for each category.

 “Category A” displays statistics about Change Requests & Amendments that were Processed Administratively in the Pre-Review Screening.

“Category B” displays statistics about Response Submissions to Change Requests and Amendments that were Processed Administratively.

“Category C” displays statistics about Change Requests & Amendments that were Expedited in the Pre-Review Screening process.

“Category D” displays Response Submissions to Change Requests & Amendments that were Expedited.

In addition, the report will break down each category into Submission, Mean, Standard, Median, Min, and Max columns.

General

Committee Roster

This report allows you to generate a roster of the members on a specific committee or all committees for the Institutional Review Board. The report can be filtered by committee. The “Select a committee” dropdown menu will populate with committees in the current review board. If all committees are selected for the filter option, the roster is categorized by committee. Within each committee the members in the roster list are categorized by the type of members (i.e. Board Member, Coordinator).

Coordinator/Protocol Analyst Workload

This report allows you to examine the workload of Assigned Analysts. It displays a listing and count of completed submissions that were assigned to Analysts. The report can be filtered by committee and start and end date. The submissions are categorized by Assigned Analyst and at the bottom of the listing there is a count for each Analyst. Each listing displays the Submission Form Name, Review Process, RB Number, PI Name, and Date Received.

Reviewer Workload (Completed/Incomplete)

This report allows you to examine the workload of assigned Reviewers. It displays a listing and count of submissions that had Reviewers assigned to them. It can be filtered by Committee and Date Range. The submissions are categorized by Reviewer and at the bottom of the listing there is a count for each Reviewer. Each listing displays the Submission Type, Review Process, RB Number, Reviewer Rank, Meeting Date (if applicable), and Outcome of the submission. You can select whether you want the report to show Completed or Incomplete reviewer assignments.

Search Studies by Keywords

This report allows you to search all studies based on certain keywords in the study title. One of the filters is the search keywords separated by commas. You can choose to search by “All words” or “Any word” when searching for key words in the study title. For example, if you want to find all studies with titles that have the words “test” and “demo” in them, you would enter “test, demo” in the first text box. Then, make sure that the radio button is selected. The studies with “test” and “demo” in the study title would populate in the report. If you wanted all studies with titles that had either “test” or “demo” in them, then you would click the radio button. The studies with either of the word’s “test” or “demo” in the study title would populate in the report. The studies can also be filtered by Study Status. Each listing includes the Study Title, RB Number, Continuing review due date, RB Expiration, Status, and PI.

Submission Turn Around
This report allows you to examine the turnaround time for submissions. Turnaround time is defined as the duration between the study submission date to the review board completion date if the submission is completed; or, if the submission is not completed, then the turnaround time is the duration between the study submission date and today’s date.

This report can be filtered by the Submission Date Range. It can also be filtered by the Turnaround Time in days and by a particular Submission Type. If a submission is completed, it will be included in the report if the turnaround time (duration between the date completed and date submitted) is greater than the number of days specified. If a submission is not completed, then it is included in the report if the amount of days between the time it was submitted, and today’s date is greater than the turnaround time specified. Details about each submission given in the report include IRB Number, Review Board, Date Submitted, whether it was completed, the Date Received, the Date Completed, and the number of days Pending. Additionally, the bottom of the report displays a calculation of the total number of overdue submissions, meaning the incomplete submissions included in the report are considered “overdue” based on your specified turnaround time.

Review Board User

Submission Review Assignment

This report allows you to see the submissions that have been assigned a reviewer. In order to see the results for the submission that have been assigned a reviewer, there must an IRB initial approval date for the study. The report is broken down by studies, where you can see each submission that had an assigned reviewer. You have the ability to filter the report by Start and End date and by Form Name. After you generate the report, you will be able to see the Study Title, Study Number, Submission Form Date, Received Date, PI First Name, PI Last Name, Review Process, Study Status, Risk, and Expiration Date.

User by Committee Role

This report displays the committee members for a specified role along with their e-mail addresses. The report can be filtered by Committee Role.

Studies By

Studies by Department

This report displays the studies associated to various departments in the system. You have the ability to filter the results by Study, Department Name, Department Code, School Code, Study Status, and Institution. The report lists the department’s studies and contains the PI Name, Study Title, Department, Department Code, School Code, RB Number, RB Expiration, RB Initial Approval Date, Continuing Review Due Date, and Funding Agencies (if applicable) for each study.

Studies by Device and Status

This report displays the studies using a device. It can be filtered by Device and Study Status. Select the devices to add in the Device to Add box and click the arrow on the right between both boxes to move it to the Added Devices box. Multiple devices can be added at once by clicking and dragging to select multiple items or using the ctrl+click method. The report contains the PI’s Name, Study Title, RB Number, RB Expiration, RB Initial Approval, and RB Continuing Review Due date.  

Studies by Drug

This report displays the studies using a specified drug(s). You can filter by Trade Drug Name, Generic Drug Name, and Investigational Drug Name. Each listing will show you the Study Title, Study Nickname, Study Status, RB Number, RB Expiration, RB Initial Approval Date, RB Continuing Review Due Date, and any Study Personnel on the study along with their designated roles.

Studies by Drug and Status

This report displays studies using a specified drug(s). However, the filters allow for more drugs to be selected/excluded when filtering the results, and Study Status can also be used as a filter. The report displays the drug name and then lists studies by Name, RB Number, RB Initial Approval, RB Expiration, and Continuing Review Due.

Studies by Expiration and Status

This report displays studies filtered by their Start and End Expiration Date Range and Study Status. Each listing includes the Study Title, RB Number, RB Initial Approval, RB Expiration Date, and RB Continuing Review Due Date, along with the PI, Co-Investigator(s), Coordinator(s), Devices, and any associated departments to the study.

Studies by Funding

This report displays studies filtered by Internal Funding Source and Study Status. The option of showing the PI and/or Co-Investigator can also be set. The report then generates a list of studies funded by the chosen internal funding source and study status. Each listing includes the Study Title, RB number, RB Initial Approval, and RB Expiration Date, along with the PI (s) and Co Investigator (s) (if you have chosen to display them).

Studies by Status

This report displays studies filtered by study status. You can choose to filter by “All,” which will group the entire list of studies by study status. If you select a specific study status, only those studies with assigned study statuses will display. The Study Title, RB Number, RB Initial Approval Date, RB Expiration Date, Continuing Review Due Date, and PI are displayed.

Studies by User

This report displays studies filtered by Users in the iRIS system and Study Status. To select a user, click the icon to open a window that will allow you to search the iRIS user directory. Each listing gives you the Study Title, the selected user’s role(s) for that study, RB Number, RB Initial Approval, RB Expiration Date, and RB Continuing Review Due Date, along with any Funding Agencies, Drugs, Devices, and Co-Investigators.  

Studies up for Expiration (in 120 days)

This report displays all expired studies and studies that will expire within the next 120 days. It excludes studies that are pending submission for continuing review.  The report lists the studies’ RB Number, whether the Submission Posted, the RB Initial Approval, RB Expiration Date, and PI Name.

Submission Statistics

Protocols Statistical Estimations

This report displays a number of different statistical analyses about studies, filtered by Date Range and Committee selection. The Period Description includes the name of different events (e.g., “Initial Submission Received to Date Analyst Assigned”), and then the count of that event happening within the given date range, Mean, Standard Deviation, Median, Min, and Max are given.

Submissions List

Approved Submission(s) by Form Name

This report displays approved submission(s) by submission form name. In order for the submission to be listed in the report, the submission must be marked as completed by the review board. You can filter the report by Study (you must either click Find to locate a specific study or Select All to choose all studies), Department, Submission Start and End date, and Submission Form Name. The report’s results include the Study Number, RB Number, PI name, along with information about the Form Name, the Review Process, the date of Submission, the date Completed, the Approval Date, and the Time in days.

Submission Final Approval

This report displays the submissions that have gained final approval from the Review Board. You can filter the report by Study, Department, and Initial Submission Date Range, and the filter information will display at the top of the report.

The list of submissions will be divided into categories by the number of times it was submitted to the board. For example, if a submission is sent back for corrections, and then resubmitted, gaining final approval, it has taken two rounds, and it will appear in the Round 2 section of the report. Each listing in the report will contain the Initial Submission Date, the Reference Number, Approval Date, Study Number, and Reviewing Time. Additionally, the report calculates the average reviewing time per round and displays this information in a pie chart at the end of the report.

Submission Initial Reviewing

This report displays the submissions that have gone through the initial review process. The report can be filtered by Study, Department, and Initial Submission Date Range, and the filter information is displayed at the top of the report.

In the report, each submission is listed along with its associated RB Number, Committee Name (if assigned to one), Review Process assigned, Study Status, Date Received and Reviewed, and the Initial Review duration. At the bottom of the report is a bar chart which displays the average initial review time for each review process type divided by study statuses.

Submission Responses Reviewed
This report displays all of the submission responses that have been reviewed by the board. The report can be filtered by Study, Department, and Initial Submission Date Range.

Each listing is divided into categories by studies. The report then calculates the reviewing time of each submission response received. The average reviewing time for each study is then represented in a bar chart in the report.

Submissions On Agenda

This report displays the submissions on agenda per committee. The report can be filtered by Study and Date Range.

The submissions are then categorized by committee, displaying their Study Title and RB Number, Reference Number, Protocol Status, PI, Form Name, Date Received, Date on the Agenda, and Difference in Days. After each committee category list, the report will display a pie chart displaying all the submissions listed according to their current status.  

This report will also display a bar chart. This chart compares the number of submissions on the agenda for each committee, and further divides the column for each committee to represent the number of submissions per status.  

Submissions Screening
This report displays the submissions screened per committee. You can filter the report by Study and Date Range.

The submissions are then categorized by committee. After each committee category list, the report will display a pie chart displaying all the submissions listed according to their status.

This report also displays a bar chart. This chart compares the number of submissions screened for each committee and further divides the column for each committee to represent the number of submissions per status.

Submission Process Tracking

Approved Submission Rounds

This report subdivides approved submissions by type of form and then displays the count of all the approved submissions, divided into rounds. You can filter this report by Submission Received Date Range and Study.

The report also calculates the average duration of the review process. The report displays a bar chart comparing the number of approved submissions per round and further divides the rounds into the types of forms.

Completed Submission Rounds

This report displays a count of all the completed submissions per round. You can filter the report by Submission Received Date Range and Study.

All the submissions are divided into how many rounds it took to gain completion, and within the rounds are subdivisions of the different types of forms in the system (Initial Review, Adverse Event, etc.). The report also contains the average duration of each type of submission. The bar chart displays the count comparing the number of submissions in each round subdivided into the type of submission.  

Submission Approval Duration
This report displays the submission approval duration measured in days. You can filter this report by Study and Submission Form.

The report displays the number of iterations (rounds) beginning with the first submission form submitted to the review board. The round number listed in the report indicates the round in which the submission was approved. The report lists the RB Number, Study Alias, Rounds taken for completion, Starting Form Name, First Submission, Approval Date, and Duration in days.

Submission Completion Duration

This report displays the duration (in days) to complete a submission regardless of the final outcome. You can filter this report by Submission Form type and Study.

The report includes the Reference Number, RB Number, Study Number, Starting Form Name, Submission Date, Completed Date, and Duration in days.

Submission Personnel Performance

This report displays how personnel are performing with regards to time spent on submissions. You can filter by specific KSP Roles, Study, Round Number, Study Status, and Date Range of the records completed.

The report divides the list of submissions by each personnel that completed the submission. It then provides you the time it took to complete each submission. It also contains information about each submission regarding the Round, Reference Number, Form Name, and the dates Received and Completed. The generated bar chart displays a comparison of the total amount of time spent on the submission in each round for each study personnel.

Submission Tasks History

This report displays the task and event history of a submission(s). You can filter the report by Study, Initial Submission Date Range, and Study Status.

The report lists all of the tasks associated with the corresponding submission. Along with the name of the study displayed in each category is the Status of the study and the Study Number. Each task listed contains information about the Event, the Submission Date, the Start and End Times, the Event Status, and the Duration of the event.

Submissions Calendar

Submissions by Form Type

This report displays the number of submissions for each type of form submitted to the review board. You can filter the report by Date.

The report divides the submission types into years and months, and then generates a monthly total and a yearly total for each. The report contains a bar chart which compares the total count of each type of submission for each year.

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Submissions by Review Committee

This report displays a count of the number of submissions for each review committee, and further divides the list of submissions into submission type. This count for each committee is generated for each month and year, along with a total for each month and year. The report can be filtered by the Start and End Date range.

The report contains a line graph representing the count of submissions for each month and comparing this information for each year.  

Submissions by Review Process

This report displays a count of submissions by review process for each month and year. The report can be filtered by Start and End Date Range.

Within each month is a count of submissions by type of review process assigned, broken down by form type. The total count of submissions is calculated for each month and year. The report contains a pie chart comparing the number of submissions for each type of review process similar to the one shown below.  

Submissions Information

Submissions by Department Selection

This report displays a list of submissions filtered by Department and Date Range.

Note: If you select a parent department, the list of submissions will only filter for that department and not its sub-departments. The list of submissions, sorted by study, includes the Submission type, Creation Date, Reference Number, PI Name, Review Type, Meeting Action, Follow Up Due, RB Label, RB Number, Expiration Label, and Expiration Date for each listing.

Submissions in Process by Department Selection
This report displays a list of all submissions that are currently in process by the current review board. You can filter by Department. Note: If you select a parent department, the list of submissions will only filter for that department and not its sub-departments.

The list of submissions includes the Review Board Number, Study Title, PI Name, Reference Number, Form Name, Creation Date, Review Type, Follow-up Due, and Expiration Date for each listing.

Completed Submissions

This report displays a list of completed submissions filtered by Records Completed Date Range and Review Process (Expedited, Exempt, etc.).  

The list of submissions is grouped according to the study they are associated with. Each listing includes the Study Title, RB Number, Reference Number, Submission Type, Review Process, PI, Assigned Analyst, Submission Date, Continuing Review Due Date, Expiration Date, and Completed Date.

Incomplete Submissions

This report displays a list of incomplete submissions that can be filtered by Date Range, Review Process, Analyst, Submission Type, and Study.

Each listing includes the Study Title, RB Number, Reference Number, Submission Type, Review Process, PI, Assigned Analyst, Submission Date, Continuing Review Due Date, and Expiration Date.  

Review Board – Approved Submissions

This report displays a list of submissions that have been approved within the filter Date Range(s).

The list of submissions is grouped according to the study they are associated with. Each listing includes the Form Name, Creation Date, Reference Number, PI Name, Process Type, Meeting Action, Approval Date, RB Label, RB Number, Expiration Label, and Date.

Review Board – Received Submissions

This report displays a list of submissions received by the Review Board within the filter Date Range(s).

The list of submissions is grouped according to the study they are associated with. Each listing includes the Form Name, Creation Date, Reference Number, PI Name, Process Type, Meeting Action, Approval Date, RB Label, RB Number, Expiration Label, and Date.

Submissions by Analysts

This report displays a list of submissions within the defined Date Range ordered by the Assigned Analyst’s first name.

Each listing includes the Form Name, Creation Date, Master Submission number, Analyst’s name, PI Name, Process Type, Outcome Action, RB Label, RB Number, and Date Completed.

Submissions by Type Selection

This report displays the submissions of the selected Submission Type received within the defined date filters.

Submissions Count by Review Board

This report displays a count of the number of submissions made to the selected review board within the defined date filters.

The count is calculated for each type of submission within each committee of the selected board, and then the totals are calculated for each type and committee. At the end of the report is a pie chart similar to the one shown below that compares the total count of submissions for each committee in the review board.

Submissions in All Stages Details

This report displays all the submissions associated with the selected department and groups them by the study they are associated with.

Each listing gives you details about every stage in the submission including the creation date/time, date/time sent to the RB, date/time sent to the PI, date/time of PI signoff, Review date/time, and expiration date and time.  

Submissions Processing

Review Board Responding Letters

This report displays a count of the outcome letters for submissions that have an Initial Review Submission date within the defined range(s). It generates not only a total count per submission round but also gives a breakdown of the count for each letter type sent within the review board.

Training

Expired Training

This report displays a list of users with training that has expired on or before the set expiration date filter(s). The listing includes the user’s name, the training expiration date, training status, and whether the training override is on or off.  

Training to Expire

This report displays a list of users with training that has/will expire within the set date range. The listing includes the user’s name, training expiration date, training status, and training override flag status.