Please note: A PDF version of this guide is available for download at the bottom of the article.
The iRIS™ system includes a robust, flexible search tool for locating studies by study number, study alias, study key words, reference number, Principal Investigator (whether active or inactive), Key Study Personnel, drugs or devices associated to the study, and more. The tool also allows for creation of custom search filters.
Note that while the screenshots shown in this manual are from specific iRIS™ modules (e.g., IACUC, Animal Resource Center, etc.), the following features and functionality discussed are the same across all modules where the “Find a Study” link and page are employed.
System labels are configurable by the institution. The terms “study” and “protocol” are used interchangeably in this manual and the included screenshots.
Navigation in iRIS™
iRIS™ includes two standard navigation tools on all pages that are nested one or more levels beneath the primary module workspace page (e.g., Study Assistant, Conflict of Interest Assistant, Animal Resource Center, etc.): a Path directory tree and a Back button.
Path Directory Tree
The Path item at the upper left of the iRIS™ header provides a hyperlinked menu directory tree, allowing the user to quickly navigate back through the path they followed to get to their current location. Path appears on all pages nested at least one level beneath the main workspace
In the example shown below, the user is viewing the Broadcast Notice 🡪 Add a new notice page. This page is nested three levels beneath the main workspace page, as indicated by the three links available in the Path directory tree: Home, board admin and broadcast notice.
Click on broadcast notice in the Path to navigate up one level in the directory tree, to the main Broadcast Notice page. There are now two levels in the Path directory tree: board admin and Home.
Click on board admin in the Path to navigate up one level in the directory tree, to the Board Administration page. There is now one level in the Path: Home.
Click on Home in the Path to navigate up one level in the directory tree to the main workspace page. No Path item is displayed here because the user is now at the top-most level of the directory tree.
Back Button
The second navigation tool is the Back button, which appears on all pages nested at least one level beneath the main workspace. The Back button takes the user to the same location as the last link shown in the Path.
In the example shown above, both the Back button and the broadcast notice link in the Path return the user to the Broadcast Notice page.
Clicking the Back button on the Broadcast Notice page returns the user to the Board Administration page, as indicated by the last link in the Path directory tree shown in the screenshot above.
Note that where the Back button appears on a page with editable fields or document upload controls, clicking the button before saving changes returns the user to the same location as the last link shown in the Path without saving changes.
Find a Study Page
Click a valid Find a Study link (Home > [module] > Find a Study) to open the Find a Study page (shown below).
Enter or select desired search criteria in the Find a Study Filters section (described below) and click the Find button to execute the search. Click the Reset Find Options button to reset all filter fields.
Find a Study Filters
The Display Projects by dropdown allows for study filtering by number type (e.g., study/protocol number, IRB number).
Text entry fields are provided to search by full or partial Study Number/Alias, Sponsor, Department, IRB Number or Reference number.
The Principal Investigator (PI) field can be used to search by full or partial PI name and includes a button to toggle the search between Active or Inactive PIs. As shown below, the button is toggled to Active by default.
Click the Active button to toggle it to Inactive, as shown below.
Note that it is not possible to search by both Active and Inactive PIs simultaneously.
The Location Status dropdown enables filtering by Location Status. Note that Location Status is configured by the institution under System Administration > Setup Locations Status.
The Study Status dropdown provides a pick list to filter the search by study status. Click an item in the list to select it.
The Study Classification dropdown provides a pick list to filter the search by study classification. Click an item in the list to select it.
Calendar widgets are provided for searching by IRB Expiration Date range. Available date range options are as follows:
— to limit the search to studies whose IRB Expiration Date occurs on or after a specific date, click the left-hand calendar widget and select the desired start date; leave the right-hand date field blank
— to limit the search to studies whose IRB Expiration Date occurs on or before a specific date, click the right-hand calendar widget and select the desired end date; leave the left-hand date field blank
— to limit the search to studies whose IRB Expiration Date occurs between two specific dates, select the desired start date using the left-hand calendar widget and the end date using the right-hand calendar widget
Find a Study Advanced Find Options
Additional search options and filters are available via the Advanced Find Options button, as shown below.
Click the button to open the Find A Study: Advanced Search Options popup, shown below.
Note that the number of panels that appear in this popup window is dependent on which module “Find a Study” is being access from. In this particular example, the IACUC assistant “Find a Study” is used, and the popup includes panels for 8 different advanced search criteria:
— Key Study Personnel
— Drugs associated to Study
— Devices associated to Study
— Drugs associated to IACUC Study
— Restraint Devices associated to IACUC Study
— Species associated to IACUC Study
— Issues Reported to the Board
— Study Key Words
Enter desired search criteria in one or more of the panels (see following subsections) and click the Apply button to apply the filter criteria to the main Find A Study search page. As shown below, when advanced search criteria are selected, the Advanced Find Options button on the Find A Study page updates with a yellow background and green checkmark to indicate that these options are in use.
Click the Cancel button on the Find A Study: Advanced Search Options popup to close it without applying any of its search criteria to the main Find A Study page.
To clear individual Advanced Find Options, click the Advanced Find Options button to reopen the Find A Study: Advanced Search Options popup. Clear any search criteria previously entered there and click the Apply button at the bottom of the popup.
Click the Reset Find Options button on the Find A Study page to clear all selected filters and/or search criteria.
For the remainder of this subsection, individual panels of the Find A Study: Advanced Search Options popup are discussed in isolation.
Key Study Personnel
The Key Study Personnel panel provides three (3) search options:
— Search for studies by the full or partial User Name of assigned Active study personnel
— Search for studies by the full or partial User Name of assigned Inactive study personnel
— Search for studies by User Role of assigned study personnel
As shown below, when the Find a Study: Advanced Search Options is initially opened, the Active button is enabled for the Select User Name field.
To search Active study personnel by User Name, enter the full or partial name in the Select User Name field.
To search Inactive study personnel by User Name, click the Active button to toggle it to Inactive, then enter the full or partial name in the Select User Name field.
Note that it is not possible to search by both Active and Inactive study personnel at the same time.
To search by User Role(s), select the desired checkbox(es) in the Select User Role(s) section. Note that the roles available here will depend on your specific system configurations. Some common roles that may appear are:
— Principal Investigator
— Additional Principal Investigator
— Co-Investigator
— Faculty Advisor
— Nurse
— Study KSP1
— Study Author
— Contact
— Department Administrator
— Administrative Assistant
— Site Contact
— Additional Project Manager
— Project Staff
— Project Manager
The Active/Inactive Select User Name and Select User Role(s) fields can be used separately or concurrently.
Drugs associated to Study
This panel is used to search for studies based on Drugs associated to Study by Trade Name, Generic Name and/or Investigational Name.
Enter the full or partial drug name in the desired field(s).
Note that a separate panel, Drugs associated to IACUC Study, is provided further down in the popup window for searching by IACUC-specific study drugs.
Devices Associated to Study
This panel is used to search for studies by Devices associated to Study.
Enter the full or partial Device Name to use this search option.
Note that a separate panel, Restraint Devices associated to IACUC Study, is provided further down in the popup window for searching by IACUC-specific study restraint devices.
Drugs associated to IACUC Study
This panel is used to search for IACUC studies based on Drugs associated to IACUC Study by Trade Name, Generic Name, and/or Investigational Name.
Enter the full or partial drug name in the desired field(s).
Note that a separate panel, Drugs associated to Study, is provided higher up in the popup for searching by non-IACUC study drugs.
Restraint Devices associated to IACUC Study
This panel is used to search for IACUC studies by Restraint Devices associated to IACUC Study.
Enter the full or partial Device Name to use this search option.
Note that a separate panel, Devices associated to Study, is provided higher up in the popup for searching by non-IACUC study devices.
Species associated to IACUC Study
This panel is used to search for IACUC studies by Species associated to IACUC Study.
Click in the field to open the Species Name dropdown list.
Click to select the desired Species Name from the dropdown list.
Note that only one item can be selected in the dropdown list.
Issues Reported to the Board
This panel is used to search for studies by Issues Reported to the Board.
The panel provides four (4) search options:
— Issue Type
— Issue reported on or after a specified date
— Issue reported on or before a specified date
— Issue reported between two specified dates
Click in the Issue Type dropdown list and click an item in the list to select it.
Calendar widgets are provided for searching by issue reporting date.
Available date range options are as follows:
— to limit the search to studies whose issue reporting date occurs on or after a specific date, click the left-hand calendar widget and select the desired start date; leave the right-hand date field blank
— to limit the search to studies whose issue reporting date occurs on or before a specific date, click the right-hand calendar widget and select the desired end date; leave the left-hand date field blank
— to limit the search to studies whose issue reporting date occurs between two specific dates, select the desired start date using the left-hand calendar widget and the end date using the right-hand calendar widget
Note that the Issue Type and Issue Reporting Range fields can be used individually or in combination to search by reported issues.
Study Key Words
Use the Study Key Words field to search for studies by keyword.
Enter desired Key Words to use this search option.
Find a Study Application Find Options
Click the Application Find Options button to create and save application (module) -specific filters for re-use as needed.
Note that Application Find Options filters can be used in conjunction with any other search criteria and filters on the Find a Study page, including Advanced Find Options.
The Find A Study: Application Search Filters page opens.
Click the Cancel button to close the page without making changes or applying filters to the current search.
Click the Add a New Application Filter button to open an add panel. In the following example a search filter is created for IACUC applications, but the same general process applies to creating IRB application filters.
Enter the desired Filter Name.
Select “Yes” or “No” for Share this Filter. A selection of “Yes” makes the filter available to other users, a selection of “No” keeps the filter private to the person who created it.
Enter any desired Comments (e.g., a description of the filter’s purpose).
Click the Add a new Filter Criteria button to construct the filter.
As shown below, a new record populates in the filter criteria table.
The fields in this criterion record are used to filter search results based on the answer(s) to specific question(s) in a study/project application form.
In this example, the filter will limit search results to those studies where the justification for using animal subjects is based on complexity of the study model and all study animals are expected to survive. Two different study application criteria must be added to the filter:
— a rationale of “The complexity of the processes being studied cannot be duplicated or modeled in a simpler system,” must be selected in response to the Animal Justification field of the application
— the answer to the question, “Is death (without euthanasia) a planned endpoint of the study?” must be “No”, as shown below
The Order field dictates the priority level of the criteria item in the overall filter. When the filter consists of a single criterion, the Order for that criterion is “1”. When multiple criteria are added to the filter, their Order values can vary.
Click on the What Application? field and select the applicable application/module from the dropdown list. In this example the “IACUC APPLICATION (ANIMALS)” option is selected, as shown below. Note that all comboboxes in this window are searchable via the text box displayed directly above the dropdown list.
The What Section? and What Question? dropdown lists are automatically populated with items applicable to the application/module selected in the What Application? field.
Click in the What Section? field and select the study application section in which the first question applicable to the filter is found. In this example, the “(400) - Project Description and Procedures” section is selected, as shown below.
Click in the What Question? field and select the question applicable to the filter. In this example, the “(22) – Animal justification” question is selected, as shown below.
Recall that in the IACUC study application, four possible answers to this question and an explanation field are provided, as shown below.
Two components, or columns, are stored as the answer to this question.
The first column contains one or more entries of the number 1 to 4), indicating which checkbox is selected. Multiple entries can be stored in the response because the user can select more than one checkbox. In the database this column is named “IACUC_ANI_JUST”.
The second column contains any text entered in the “Provide further explanation of your selection(s) made above:” text box. In the database this column is named “IACUC_ANI_JUST_EXP”.
Note: Because column titles are not always named in descriptive, plain English, strong knowledge of the fields and tables involved in constructing the filter is required to avoid errors.
Click on the What Column? field and select the column that contains the data value applicable to the filter. In this example “IACUC_ANI_JUST” is selected.
As shown below, because the answer to this question offers four possible options in response, a “Which Option?” field appears to enable further specification.
As explained above, the dropdown list contains four options. In this particular example, the first option (“The complexity of the processes being studied cannot be duplicated or modeled in a simpler system.”) is selected, as shown below.
Click in the Comparator field and select the desired item from the dropdown list. Comparators are used as follows:
— EQUAL is used for comparisons against either text or numeric field values and is equivalent to the “=” mathematical operator; the Value entered for comparison must exactly match the value entered in the application form, including all letters, spaces and characters when used for text field comparisons
— NOT EQUAL is used for comparisons against either text or numeric field values and is equivalent to the “≠” mathematical operator; the Value entered for comparison must not match the value being compared in the application form, including all letters, spaces and characters when used for text field comparisons (e.g., NOT EQUAL to “Syrian hamsters” is not the same comparison as NOT EQUAL to “hamster”; the former comparison would exclude all records containing the specified species “Syrian hamsters”, the latter would exclude all records with the word “hamster” anywhere in the species field)
— LESS THAN is used for numeric field value comparisons only and is equivalent to the “<” mathematical operator
— LESS THAN EQUAL is used for numeric field value comparisons only and is equivalent to the “≤” mathematical operator
— GREATER THAN is used for numeric field value comparisons only and is equivalent to the “>” mathematical operator
— GREATER THAN EQUAL is used for numeric field value comparisons only and is equivalent to the “≥” mathematical operator
Select the Value against which the Comparator will be used.
In the case of Yes/No select checkboxes or radio buttons, three possible options may be shown in the Value column:
— “Yes”, which is the value stored in the database when the checkbox/radio button for the item is selected
— “No”, which is the value stored in the database when the checkbox/radio button for the item is not selected
— “Not Set”, which is the value stored in the database when no checkbox(es)/radio button(s) for the item is(are) selected, indicating that the question was not answered; this option is only available for fields where a response is not required in the study application, or for draft applications where the question has not yet been answered
The example shown below demonstrates behavior of the Value field when the filter comparison is against a text entry.
In this type of comparison, the Value column contains a text entry field.
Returning to the original filter example, a second filter criterion is required to fulfill the filter parameters. Click the Add a new Filter Criteria button to add another filter criterion.
A second criterion record appears below the first.
Follow the same steps as for the first criterion row to populate the new row. In this example, the second comparison is against the answer to the question, “Is death (without euthanasia) a planned endpoint?”
The filter in this example is now complete. If additional criteria rows are needed, click the Add a new Filter Criteria button and follow the steps outlined above to add and populate them.
If any criteria are added in error, click the delete icon in the far-left column to remove the unwanted criteria. A confirmation popup window displays.
Click CANCEL to close the popup without deleting the criterion.
Click CONFIRM to delete the record and close the popup.
Back on the Find A Study: Add Application Search Filter popup, click the Return to List button to close the popup without saving the filter.
Click the Save button to save the filter and close the popup.
If Save was clicked, the filter is added to the Find A Study: Application Search Filters page.
Click the icon in the Edit column (shown below) for any filter on the page to reopen the add panel for that filter and make revisions.
Click the icon in the Delete column (shown below) for any filter on the page to delete the associated filter.
A confirmation popup window displays.
Click CANCEL to close the popup without deleting the filter.
Click CONFIRM to delete the filter and close the popup.
Select the radio button in the Select column to display a preview of Criteria to Apply for the applicable filter, as shown below.
Note that temporary changes can be made to active fields in the Criteria to Apply preview before applying the filter, but these changes will not be saved to the filter. To make and save changes to the filter, click the icon in the Edit column.
Click the Cancel button to close the Find A Study: Application Search Filters page without applying the selected filter.
Click the Apply button to close the page and apply the selected filter. As shown below, the Application Find Options button on the Find A Study page updates with a yellow background and checkmark to indicate saved application filters are in use.
Application Find Options remain active on the Find a Study page until the filter selection is cleared.
When more than one Application Find Options filter is in use, to clear an active filter click the Application Find Options button to reopen the Find A Study: Application Search Filters page. Clear the Select column radio button for any filter(s) to be removed from the search and click the Apply button at the bottom of the page.
Click the Reset Find Options button on the Find a Study page to clear all selected filters and/or search criteria.
Application Find Options filters can be used in conjunction with any other search criteria and filters on the Find a Study page, including Advanced Find Options.
Viewing a Study Record
To view a study in the Find a Study results, click the study’s icon in the Open column.
The selected study is opened and the user taken into the study record. By default, this page opens to the Submissions tab, as shown in the screenshot below.
The Submissions tab displays any forms available for viewing by the review board. If the study is being access from the study-side of the system, this page will display all forms available to the research team for submitting to a review board. The study’s Informed Consents, Other Study Documents, Submission History and Study Correspondence are also accessible from this tab.
The Submissions History Link provides access to track the workflow of the initial submission and any other submission forms processed by the review board (shown in screenshot below). Clicking on a link under Request Type opens submission processing screens for that submission.
Click the Study Correspondence link to access a list of all notifications, signature requests, and notices that pertain to the study (shown in screenshot below).
Back on the Submissions page, click the Study Management tab (shown in screenshot below) to access additional study information and tracking tools.
Common Rule Display Option
When the rb.use_common_rule_display property (under [review board module] > Review Board Administration > Board Configuration Options) is set to “Yes”, a Common Rule filter is added to the search form on the Find A Protocol page and a 2019 Common Rule? column is added to the result set (see red boxes in screenshot below).
The Common Rule filter field is comprised of a dropdown menu with the following options: “2019” Common Rule studies, “1991” Common Rule studies, or “All” studies. The default selection is “All”.
This value is based on the selection made in the Select Categories For Study dropdown on the Outcome tab (see screenshot below).
When the rb.use_common_rule_display property is set to “Yes”, an associated Merge Code (“Common Rule”) is made available for use in Meeting Minutes, Meeting Agendas and Outcome Letters. The Merge Code field populates with the applicable rule.
Also, when the property is set to “Yes”, the applicable rule displays in the Study/Submission header (shown below).