The IRB Assistant menu provides links to tools for processing and tracking of submission reviews, signoffs, member reviews, meetings, and more.
Note that menu items are dictated by the institution’s specific system configuration, and may differ from those shown in the screenshot above.
Review Board Limited Administrator Role
When the rb.use_limited_admin_rights property (under Board Configuration > Board Setup) is set to “Yes” an option for limited administrator rights is made available when giving users administrative board level access.
As shown below, users granted this rights level are given access to the Review Board Administration icon in their main workspace, as well as the corresponding menu link.
Clicking the icon or link loads the limited version of the Board Administration menu, shown below.
An example of a standard, full Board Administration menu is included below for comparison. Note that the full Board Administration menu is configurable by the institution and may differ from that shown below.
Find a Study
Click the Find a Study link to open the Find a Study page (shown below).
Enter / 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.
The Display Projects by dropdown allows for selection 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 name, 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 allows for selection 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.
The popup includes panels for eight (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 panels (see following subsections) and click the Apply button to apply the desired 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 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 shown 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 popup initially loads 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. The full list includes the following roles:
— 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
— Post Doctoral (Grants.gov - Post Doctoral)
The Active/Inactive Select User Name and Select User Role(s) fields can be used separately or in combination.
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 for searching by IACUC 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 for searching by IACUC 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 and/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, available text entry fields and dropdown lists are activated.
The activated fields are used to filter search results based on the answer(s) to specific question(s) in the 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 in 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.
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 from the dropdown list. 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 from the dropdown list. 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(s) one (1) to four (4), indicating which checkbox(es) is(are) 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 in the What Column? field and select the column that contains the data value applicable to the filter from the dropdown list. 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 is added.
As explained above, the dropdown select list contains four options. In this 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 exactly 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. If anything is entered in the field in error, click the small “x” at the far right of the field (yellow arrow in screenshot above) to clear it, then enter the desired Value.
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.
An additional row of fields is activated in the lower section of the popup, as shown below.
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 add panel 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.
The filter is added on 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 green 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.
Where 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.
To view a study in the result set, click the icon in the Open column. The selected study is opened in the study Submissions page. 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 IRB. 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 IRB > System Configuration) 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).
Note that when the property is set to “Yes” these same changes are applied to the Find a Protocol/Study page under Submissions. See the Submissions > Common Rule Display Option section of this manual for more information.
The Common Rule filter field includes radio buttons to select “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).
Where 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, where the property is set to “Yes” the applicable rule displays in the Study / Submission header (shown below).
Submissions
The Submissions link provides access to view and process submissions sent to the IRB.
See the Submission Processing manual for more information about this feature.
Common Rule Display Option
When the rb.use_common_rule_display property (under IRB > System Configuration) is set to “Yes” a Common Rule filter is added to the search form on the Board Submissions page and a 2019 Common Rule? column is added to the result set (see red boxes in screenshot below).
Note that when the property is set to “Yes” these same changes are applied to the main Find a Study page. See the Find a Study > Common Rule Display Option section of this manual for more information.
The Common Rule filter field includes radio buttons to select “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).
Where 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, where the property is set to “Yes” the applicable rule displays in the Study / Submission header (shown below).
Analyst Dashboard
The Analyst Dashboard link provides access to study tracking and management tools used by Analysts.
See the Analyst Dashboard manual for more information about this feature.
Reviewer Assignment
The Reviewer Assignment link provides access to the logged in user’s current Incomplete, Complete and Canceled Reviewer assignments.
Incomplete Tab
By default, the Assigned Submissions for Review page opens to the Incomplete tab.
Click the icon in the Click to open column to open the corresponding assignment. Use the Display Submissions by dropdown menu to display submissions by “IRB Number” or other study numbering.
Complete Tab
Completed review assignments are listed on the Complete tab.
Enter a number in the Reviews Completed within the last text box on the Complete tab to specify the date range for assignments to be displayed. Click the icon in the Click to open column to open the corresponding assignment and access the completed form.
Canceled Tab
Canceled review assignments are listed on the Canceled tab.
Notice that there is no Click to open column as these assignments are inactive and retained for audit log purposes only.
Reviewer Dashboard
The Reviewer Dashboard link provides access to submissions for which the logged in user is assigned as Reviewer.
See the Reviewer Dashboard manual for more information about this feature.
Meeting Management
The Meeting Management menu contains links for Meeting Manager, Meeting Agenda, Meeting Minutes, and Meeting Availability.
See the Meetings manual for more information about these features.
Monitoring
The Monitoring menu contains links for Continuing Review Monitor, Outstanding Responses, and Stipulations Tracking.
Continuing Review Monitor
The Continuing Review Monitor link provides access to study management tools for submissions under continuing review. Submissions within 120 days of their continuing review date populate in this list.
The list can be sorted by the number type selected in the Display by dropdown list (upper right corner in screenshot below).
The results list includes fields for selected Display by number, IRB Initial Approval, IRB Expiration, Principal Investigator, and whether the submission is Posted (meaning that an in-process submission exists to satisfy Continuing Review requirements).
This list allows the review board to monitor studies coming up for Continuing Review and take action on any study that missed its Continuing Review deadline. Applicable studies remain in this list until the study record is updated by either closing it for lack of Continuing Review submission or extending the IRB Expiration date. Click the icon in the Open column to open the corresponding submission in the Study Management page.
The full Study Profile is accessible via the Study Management tab of the Submissions page.
Outstanding Responses
The Outstanding Responses link provides access to the Response Due page.
The Response Due page is used for management of submissions sent back to the PI / KSP for corrections or changes.
Filters are provided at the top of the page to search by Principal Investigator, IRB Number, Form, Analyst, Outcome, Follow-up date range, Reviewer or Date Sent range. Click in the Display Response by field to select the desired number type (e.g., IRB Number, IACUC Number, etc.).
Set filters as desired and click the Find button. Click the Reset Find Options button to clear all filters.
Click the icon in the far-left column of the result set to view a table of results for the corresponding original submission, and to access the Outcome tab for the submission. Submission location tracking and KSP correspondence options can be accessed from the submission processing screens.
The following columns are shown in the result set:
Letters –an icon will only appear in this column if an outcome letter was created and sent; hover the mouse over the icon to view letter type(s) (see below)
Outcome - submission review outcome
IRB Number - review board number used to reference the study
Ref Number - system-generated reference number for the submission
Type - type of submission
Date Sent – date that the submission was sent back to the PI/KSP for corrections or changes
Follow-up Due - follow-up date (see the Submission Processing manual for more information)
Principal Investigator - Principal Investigator assigned to the study
Department /Study Number - Primary Department on the study and Study Number/Nickname
Analyst Assigned – Analyst, if any, assigned to the submission
Reviewer(s) - Reviewer(s), if any, assigned to the submission
Meeting Date - if the submission was put on an agenda, the agenda date is displayed here
Note that Review Outcome for a submission is assigned on the Outcome tab (see screenshot below). Submissions with a Review Outcome selected where the Additional Information required field is set to “Yes” remain in the Outstanding Responses queue until a new version of the submission is received.
Stipulations Tracking
The Stipulations Tracking page is used for tracking and editing submission stipulations.
Stipulations are displayed on Open Stipulations and Closed Stipulations tabs. Search filters for review board Number (based on the Display by selection of “IRB Number”, “IACUC Number”, etc.), Reference Number, Follow-up Date range and Stipulation Type are provided at the top of each tab.
Columns in the Open Stipulations tab display as follows:
IACUC/IRB/IBC Number –review board number assigned to the study
Ref Num –submission reference number
Type – type of submission form in which this stipulation was entered
Principal Investigator –Principal Investigator associated with the study
Stipulation Type – type of stipulation
Follow-up Due –follow-up due date, where the stipulation type is “Comments that must be addressed”
Response Acknowledge – whether the PI accepted the stipulation
The actual Stipulation entered by the review board and the Response from the study side display in the green highlighted area. Note: study management cannot create a Response to the stipulation until the review board returns the submission to the study.
Click the icon in the Open column for the applicable stipulation to open the submissions screen (shown below).
Click the Edit icon to open the Process Stipulation screen (shown below). A Review Board Action can be assigned, and the date that the stipulation was closed can be entered in the Review Board Date Closed field.
Click the Add Memo button to add a memo to the stipulation. A text editor page opens for creation of the memo. Click the OK button to save the memo and close the text editor.
Any memos added display in a table.
To delete a memo in the table, select its corresponding checkbox in the far-left column and click the Delete Memo button.
To edit a memo in the table, click its corresponding icon in the Edit column.
Click the Save Stipulation button to return to the Stipulations Tracking page. If a Review Board Action and a Review Board Date Closed were entered, the stipulation moves from the Open Stipulations tab to the Closed Stipulations tab.
Select the Closed Stipulations tab. A screen similar to the Open Stipulations tab opens, listing all closed stipulations (see below).
Two additional columns appear on the Closed Stipulations tab – Action and Date Closed. These are populated with selections made in the Process Stipulation screen as described previously. Submissions corresponding to the stipulation can be opened or edited here as well, as described previously.
Correspondence & Notifications
The Correspondence & Notifications menu includes links for Correspondence, Drug/Device Email and Audit System Notifications.
Correspondence
The Correspondence tool allows provides access for processing and tracking all IRB correspondence sent through the system.
The Correspondence menu group is typically available only to Review Board Coordinators and Administrators. However, read/write access can be granted to any role on the board through Review Board Administration – Setup Role Access.
The Correspondence link opens the Board Correspondence page. Any correspondence generated through the IRB Assistant module or sent to the IRB Assistant module creates an audit log entry on this screen.
Columns on the page populate as follows:
Author –author of the correspondence
Subject –date and time the correspondence was sent, its subject title, and IRB number (if applicable)
Posted – “Delivery in Progress” displays when a newly-sent correspondence is in process, the date and time stamp display when the item is delivered
Click the icon in the View Message column to open the corresponding message. The correspondence is displayed in read-only format, as shown below. The Subject, IRB Number, Recipient(s), any Additional Recipient(s), and any attachments to the correspondence are also displayed. Delivery in Progress is displayed if the correspondence is newly-sent and in process.
Back on the Board Correspondence page, to reply to a correspondence, click the Post a Reply to this Topic link above the correspondence.
The Board Correspondence page opens for creation of the reply (see below).
Fields and controls on this page are as follows:
Send Email – select this checkbox to send the correspondence to specified recipients via email
Subject – defaults to the original correspondence subject, but is editable
IRB Number – if the correspondence is associated to a study, the IRB Number of that study displays here
Recipient(s) – recipient(s) of the correspondence, pre-populated with prior recipient(s) and/or author of the original correspondence unless the recipient/author is the current user; select the heading link to configure this field in the Correspondence contact page (see below)
If the correspondence is associated to a study, Key Study Personnel are listed by name and role. To add personnel to the recipient list, select the checkbox next to the appropriate user. Use the icon in the select column header to select or deselect all. When selections are complete, click the Save Changes button.
Additional Recipient(s) – Select this link to send this correspondence to person(s) not already listed in the system; the Correspondence Additional Contacts page opens for creation of the new contact (see below.)
Click the Add A New Contact button. A new row populates for entry of contact information (see screenshot below).
Name and E-mail Address fields are required. E-mail Address must be entered in name@domain.com format or an error message will be displayed.
Repeat this process for additional new contacts.
To delete a contact added to the list in error, select its corresponding checkbox in the far-left column and click the Remove Selected Contacts button.
After all contacts are entered click the Save and Return button to save changes and close the Correspondence Additional Contacts page.
The Reply To(s): field lists users in the Recipient(s) list when a reply is posted to this correspondence, either from the system or from an inbox; users can be added to this list in the same manner as adding Recipient(s).
The Additional Reply To(s): field lists users in the Additional Recipient(s) list when a reply is posted to the correspondence either from within the system or from an inbox; contacts can be added to the list in the same manner as adding Additional Recipient(s).
Click the Add Attachments button to add a document to the correspondence as an attachment; the Add Attachment page opens for upload of the attachment (see screenshot below).
A Title must be entered for the attachment.
Click the Upload button to open the upload dialog box (see below).
Click the Browse button to navigate to the document.
Click Cancel to close the upload dialog without adding an attachment.
Click Open to proceed with the upload. When the upload is complete click the Save And Return button; the section refreshes as shown in the screenshot below.
Click an attachment name or icon to view the attachment.
To delete an attachment, select the checkbox next to the corresponding attachment(s) and click the Delete Attachment button.
More attachments can be added via the Add Attachment button. Note that while there is no limit on the size of the documents uploaded, certain email systems will have a limit on the size of incoming mail; therefore, it is advisable that the uploaded documents do not exceed a total of 1 MB when sending correspondence as email.
Enter the body of the correspondence text in the Content field of the text editor.
Click the Save and Send Correspondence button to save the correspondence and send it to the specified recipients.
Click the Save Correspondence as a Draft button to save the correspondence as a draft and not send it.
Click the Forward this Topic link, located next to the Post a Reply to this Topic link, to forward a copy of a correspondence.
Correspondence(s) saved as draft(s) are editable via the applicable icon(s) on the Review Board Correspondence page.
To add a new correspondence, click the Add a New Correspondence button. This opens a page similar to the Post a Reply page, but without any pre-populated data.
Only correspondence(s) saved as draft and never sent may be deleted (see screenshot below).
A checkbox appears next to correspondences that may be deleted. To delete a correspondence, select the applicable checkbox and click the Delete Selected Correspondence button.
Drug/Device Email
The Drug/Device Email link opens the Drug/Device Email page (shown below).
This page is used to send a study-related drug or device email to that study’s contacts. Emails of this type are typically used for pharmaceutical recalls or notes that must be sent to all study contacts using a specific drug or device.
Four filters are provided to search for the drug/device: Select a Drug by Trade Name, Select a Drug by Generic Name, Select a Drug by Investigation Name, or Select a Device. A result list containing all studies matching filter conditions populates in the table beneath the filters.
To send a drug/device email, select the checkbox next to the applicable study. Enter a Subject line for the email and desired body text. Click the Send Email button in the upper right-hand corner to send the email.
The email is sent to all applicable study contacts.
Audit System Notifications
The Audit System Notification link opens the Setup Audit Notifications page (shown below).
Every notification sent by the system is logged and can be tracked. All system notifications can be audited here to verify they are sent.
The Audit Notifications page includes several filters at the top to assist in searching for notifications.
Available filters include Notification Type, Recipient(s), Date Range, IRB Number, or keyword search of the Subject or Content of the notification.
Select a Notification Type from the dropdown list (shown below) to filter by Notification Type.
Use the Recipient(s) option to perform an audit for a specific user in the system who was in the distribution list for the applicable notification. Click the Select User button to open the Search User Directory page (shown below).
Enter desired search criteria and click the Find button. Use the “%” symbol to perform a wildcard search, displaying a list of all users in the system.
Click the Icon next to the applicable name to close the search page and return to the Setup Audit Notifications page with that user added.
Click the Clear User button to clear the selected user name. Note that it is only possible to search by user with one name at a time; click Select User after clearing the name to search by user again.
Use the Date Range filter to search by the approximate date of the notification.
The type of number to enter for Review Board Number depends on the selection made from the “Display Studies by” dropdown list.
Enter a key word or phrase that appears in the Subject to filter by Subject key word. Use the “%” symbol to perform a wildcard search.
Enter a key word or phrase that appears in the Content of the notification to filter by Content key word. Use the “%” symbol to perform a wildcard search.
Provide information for one or all of the search fields to locate the necessary notification, or click Search with no filters entered to return all results in the system.
Results are displayed in a table under the filter options, with the most recent notification at the top of the page, in sets of fifty (50) results per page. The following columns populate in the search results: View, Notification Type, review board Number, Date Posted, Subject, Recipient(s), and Additional Recipient(s).
Notifications can be sorted to display in ascending or descending order by clicking the applicable column heading (shown above). Sorting is not available for the View and Recipient(s) columns.
Click the icon in the View column to view the sent notification. The notification opens as read-only in a page similar to the screenshot below.
User Management
The User Management menu provides access to links for Grant User Access & Define Roles, Member History, and User Training.
Grant User Access & Define Roles
The Grant User Access & Define Roles page lists any users in the system who currently have a role on the review board.
The list includes board member names, committees, roles, voting member status and board experience status. Where available in the system, board member specialty and affiliation are displayed as well.
To delete a board member, select the box in the far-left column for the applicable name and click the Delete Selected Member(s) button.
To change a board member’s access rights, click the icon in the Edit column for the applicable name. The user record is opened in an edit panel (shown below).
Change the user’s board member role by selecting a different role within the applicable committee on the right-hand side of the edit panel. Where applicable, select the checkbox(es) for:
Committee Access – select to grant this board member access to this committee
Voting Member – select to indicate this member has voting rights on the committee
Experienced Member – select to indicate this member has prior experience on this board/committee
Click the Save Member Info button to save changes, then click Back to return to the list.
Click the Add a New Member button to assign any other user in the system who is not already on the board to a board member role. The Add new Review Board Members page opens, as shown below.
Click the Save Selected Members button to save changes and close the page.
After assigning a system user to a board member role, it is necessary to navigate to their user account to configure their specific board role. This process is the same as that described previously for editing access details of a current board member.
Review Board Member History
The Member History link provides access to audit logs of review board member role history.
Note that access to this feature is controlled under Review Board Administration > User Roles and Access, and the Member History menu item only populates for users in roles that are granted access.
By default the Member History page opens to the Active tab, for lookup of current board member role assignments.
Enter desired search criteria (Last Name, First Name, Username, Role, Status, date range) and click the Find button to run the search. Use the Display by Committee dropdown list at the upper right of the page to filter search results further.
Notice that each user can have multiple history entries, one for each role assignment on each board. A user may also have multiple entries for a role if they held that role for two periods of time.
Click the Print button to print the results displayed on the screen. To print all of the records in the result set, change the records per page dropdown to “All”. It is also possible to print to PDF using that browser function.
Click the History tab (shown below) for lookup of role assignment history for past board member role assignments.
Notice that the filter form at the top of this tab includes the same fields as on the Active tab, but adds fields for Status and date range. The search form on the page defaults to a range from the current date going back one year, but the dates can be changed.
There are two areas in the system where board role assignments and changes can be entered. The first is the Grant User Access & Define Roles page within a review board module, as shown below.
See the Grant User Access & Define Roles section of this manual for more information.
The second is at the System Administration level, and is accessed via System Administration > System Administration Workspace > User Accounts > Assign Access link for applicable user.
See the System Administration manual for more information about this feature.
Member History Audit Log
When a user is added to a review board the system creates an audit log entry that includes the user name, the start and end dates for the role assignment, the role title, and the name of the user who made the role assignment.
When a current board member is assigned to a different role on the same board, the system automatically enters the date of the new assignment as the end date for the user’s previous review board role, and as the start date for the new review board role. These dates are then saved to the audit log, along with the name of the user being reassigned, the new role title, and the name of the user who made the change.
Deactivating, terminating or retiring a user account populates the end date(s) for any role(s) the user holds at that time.
User Training
The User Training menu link provides access for viewing and configuration of each user’s training record. See the Sys Admin - User Training - Full manual for full details of training management features in the system.
Validation of user training can be part of the submission workflow, allowing for verification that Key Study Personnel are up to date with the review board’s required training or education. Entry of user training data is only necessary if this verification step is part of the institution’s workflow. Contact your site’s system administrator for questions concerning your site’s workflow.
The User Training List page displays a list of all users associated with the active review board.
The table includes columns for Edit/View, User Name, User ID, Primary Department, Training Group, training Status (Active, Never Active, or Expired) and Override.
The icon in the column between Primary Department and Training Group signifies the user has at least one active training record on file. The
icon means there is no valid training record on file. The
icon signifies the user has a training record on file but that record is expired.
A search form is provided at the top of the page to search for users by Last Name, First Name, User ID or Status. Enter desired search criteria and click the Find User button.
To set up a user training record, click the icon in the Edit/View column for the applicable user or click on the applicable user name. The user’s Training record list is opened in read-only format (see below).
Tabs for user Training Group Status and User Training Courses are provided at the bottom of the page.
The Training Group Status tab lists Training Groups to which the user is assigned. A Training Group is a set of courses that form a required curriculum.
Next to each group is a list of courses the user has taken that are applicable to that group. The page provides access to Edit/View User Training Courses, Reevaluate Training Status, add a New Training Group, or Delete Training Group(s).
Click the Edit/View icon for a Training Group to open its configuration details, as shown below.
Group Name is read-only. The Override Flag and (training) Status fields are editable.
Set the Override Flag to “Yes” to override any necessary training rules set up for the group for this user only.
The (training) Status dropdown list includes the following options:
Never Active — training was never set; default setting
Active — training is currently active
Expired — training is expired
Click the Save Training Group button to save changes and close training group configuration details.
Click the Reevaluate Training Status button to revalidate the active user’s training.
To add a new training group, click the Add New Training Group button. The same configuration form used for revising an existing training group is opened for creation of the new group.
Group Name – select the desired training group name from the dropdown list
Set the Override Flag to “Yes” to override any necessary training rules set up for the group for this user only.
Select the desired option from the (training) Status dropdown list:
Never Active — training was never set; default setting
Active — training is currently active
Expired — training is expired
Click the Save Training Group button to save the new group and close training group configuration details.
Back on the User Training Group Status tab (shown below), to delete a training group, select the box to the left of the applicable training group and click the Delete Training Group(s) button. Click the button at the top of the column in the table to select or deselect all groups.
Click the User Training Courses tab to view the user’s training record list, as shown below.
The list table includes columns for Course Name, Course Date, Expiration Date, Score and course Description. Click the icon in the Edit/View column for a course to open its configuration details (shown below).
The Course Name field is read-only.
The fields for Course Date, Expiration Date, Score and Description are editable. A field is also provided to add Comments about the course. Click the Add a New Document button to attach a document to the course (e.g., a certificate of completion). Complete fields as desired and click the Save Training Course button to save changes. Click the Back link to close the configuration form.
Back on the User Training Courses tab (shown above), to add a new training course for the selected user, click the Add New Training Course button. The same configuration form used for revising an existing training course is opened for creation of the new course.
Course Name – select the desired training course name from the dropdown list
Course Date – date the course was taken
Expiration Date – training course expiration date; if no Expiration Date is entered the user remains in good standing with the associated course indefinitely
Score – training course score
Description — course description
A field is also provided to enter Comments about the course.
Click the Save Training Course button to save changes.
The course is added to the list of courses within the applicable group for the selected user.
To delete a training course select the checkbox for the applicable course in the far left column, then click the Delete Training Course(s) button.
The system automatically checks the expiration dates for training courses and automatically updates course status as per the rules defined for a particular training group.
Letter Signoff
The Letter Signoff feature allows for application of an electronic signature to outcome letters routed to the logged in user for approval. Click the Letter Signoff link in the IRB Assistant menu.
The Assigned Letter Signoff List page opens, as shown below.
Signoff for individual letters can also be accessed through the task list displayed on the home screen.
The page includes an Incomplete tab and a Complete tab. The Incomplete tab lists submission letters awaiting application of electronic signature. Submission letters to which the electronic signature has been applied are listed on the Complete tab.
The page opens to the Incomplete tab by default. Submissions shown here are listed by the selection made in the Display Submissions by field (IACUC Number, IRB Number, etc.).
Data columns shown for each record include IACUC Number (or other number selected in the Display Submissions by field), Ref Number, Type, Review Process, Date Letter Created, Continuing Review Due date, Expiration Date, Principal Investigator and Assigned Analyst.
Click in the Filter Letters By field and select Batched only or Non-Batched only to filter by batched status. Note that batched or non-batched status is set when the letter is created.
Click the icon in the Click to open column to review the submission before signing its letter(s). Submission processing screens open for the study. Use one of the following two methods to apply the electronic signature:
1. Batch Review and Sign Off (fastest method)
Select the checkboxes in the first column for all items to be signed off and click the Sign all selected Letters button. A warning message appears, as shown below.
Click OK to confirm the batch signoff. A form opens for entry of user credentials, as shown below.
Enter the logged in user’s User ID and Password (electronic signature) and click the Save button. The countdown alert popup shown below displays briefly.
Note that this popup displays regardless of whether the letter is already in PDF format, or if the letter must still be routed for signature.
2. Non-Batch (Individual) Review and Signoff (more time consuming)
Click the Edit/View Letter icon for the applicable signoff item. The item is opened in a page like that shown below.
If letter content is editable, it is presented in Word format. Otherwise it is presented in PDF format.
Submission information (Reference Number, Submission Type, and Approve/Deny) appears on the left side of the page.
Click the Click here to add comments button to open the Signoff Comments Editor popup, shown below. Enter desired comments and click the OK button.
Approve or deny the letter by selecting the appropriate choice from the dropdown menu. A new field for application of electronic signoff appears after this selection is made (see below).
Enter the logged in user’s User ID and Password (electronic signature) when prompted and click the Save Letter Review button.
After this process is complete the main Assigned Letter Signoff list is updated to read, “No Letters to Review and signoff.”
The Complete tab displays all letters to which the logged in user’s electronic signature has been applied. This list can be filtered to a specific date range using the Start Date and End Date fields. After setting a date range, click the Refresh page button to apply the date range filter.
Invoice History
The Invoice History link opens the Board Invoice History page.
This page is used for tracking and managing invoices associated with “fee applied” submissions.
Not Invoiced Tab
By default, the Board Invoice History page opens to the Not Invoiced Tab. An Invoice History Filters panel is provided at the top of the page.
The Display Submissions by dropdown allows for selection by number type (e.g., study/protocol number, IRB Number, etc.).
Text entry fields are provided to search by full or partial Study Number/Alias, Sponsor name, 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 allows for selection 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.
Select the Include studies that have not been assigned an IRB number checkbox to include those studies in the result set.
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
Use the IRB Review Type and Review Level dropdown pick lists to limit results by the Review Level and / or IRB Review Type specified at the time the invoice was configured in the Setup Board Invoice Type List page (example shown below, this feature is accessed under Review Board Administration).
Click the Reset Find Options button to reset all fields in the Invoice History Filters section.
All IRB “apply fee for service” submissions are listed on this page. The Not Invoiced tab is loaded by default when the page opens. Incomplete and Complete tabs are also provided.
The Not Invoiced tab lists all “apply fee for service” submissions that have not yet been invoiced.
Click the applicable icon in the Open column for an invoice item to view its details on the Submission Invoice page (shown below).
Data fields and elements on this page include:
Projected Invoice Number — next available invoice number to be assigned; after the invoice number is assigned this label changes to Invoice Number
Journal ID – enter the unique Journal ID number
Journal Fiscal Year – enter the fiscal year of the journal in which this invoice was created
Study Status – color coded study status label, read-only field
Review Level – select the board review level (e.g., Process Administratively)
IRB Review Type – select the board review type (e.g., Full Committee Review)
Waive Fee? – select “Yes” to waive the fee; this selection populates Reason for Waiving Fee? and Percentage Waived fields, as shown below
Note that the Reason for Waiving Fee? picklist is configured under Review Board Administration > List Maintenance Setup > Setup Waive Fee Reason link. When the list is configured a Percentage Waived is assigned to each Reason for Waiving Fee, and is brought in to this page automatically.
Waive Invoice — select “Yes” to waive the invoice; this selection populates the Reason for Waiving Invoice? field, as shown below
Note that the Reason for Waiving Fee? list is configured under Review Board Administration > List Maintenance Setup > Setup Waive Invoice Reason link
Amount Due — enter the dollar amount of the review service fee
Amount Received — cumulative dollar amount of all payments received for this submission, read-only, automatically calculated by the system
Balance Due — remaining balance of fees due for the submission, read-only, automatically calculated by the system
Invoice Type — submission type associated with the fee; note that this list is configured under Review Board Administration > System Setup > Setup Invoice Type link
Invoice Template — invoice template to be used; note that this list is configured under Review Board Administration > System Setup > Setup Invoice Template link
Complete Date — date that the invoice is paid in full; note that in cases where multiple payments are received on the same submission this is the date the final payment is received
Complete — select “Yes” to move the invoice item to the Complete tab on the Board Invoice History screen
Invoice Documents — list of invoice documents associated with the submission
Invoice Payments — list of “fee for service” payments received on the submission
Verify and update the Amount Due and Invoice Type fields (if necessary) before creating the invoice document to ensure accuracy.
Click the Save Changes to Invoice button to save changes and enable system features used to create invoice documents and add payments for the submission.
Notice that a Create Invoice Document button populates above the Invoice Documents table (shown in screenshot below) after the Save Changes to Invoice button is clicked.
Notice that an Add a New Payment button populates above the Invoice Payments table (shown in screenshot below) after the Save Changes to Invoice button is clicked.
Click the Create Invoice Document button to generate an invoice against the submission. A pre-configured invoice template opens in a text editor window, as shown below.
When changes to the invoice are complete click the Save Letter Changes button to close the text editor and return to the Submission Invoice page.
The invoice is added to the Invoice Documents table on the Submission Invoice page, as shown below.
To delete an invoice from the Invoice Documents table, click its corresponding icon in the Delete column.
To create a routing list for an invoice document and send it, click the icon in the Send column for the applicable invoice document. The Board Invoice Recipients page opens, as shown below.
All Key Study Personnel are added to the distribution list by default. To add a name to the distribution list, select the corresponding checkbox in the Send if checked column. To remove a name to the distribution list, deselect the corresponding checkbox in the Send if checked column.
If the study is associated to a sponsor, a Select Sponsor to Add Contact(s) dropdown pick list and Add Contact button are provided above the Sponsor section of the page, as shown below.
Select the applicable sponsor from the pick list, then click the Add Contact button. The Find a Sponsor Contact popup window opens, providing a tool to search the system for the existing sponsor’s contacts. If records exist for sponsor contacts associated to the study, they are listed here and are selectable.
If no records exist for sponsor contacts associated to the study, click the Add a New Sponsor Contact to search the master list of existing business contact records for the institution. The Find a Sponsor Contact: Search Options popup window opens, as shown below.
Enter desired search criteria in the Last Name, First Name and/or Division filter fields and click the Find Sponsor Contact button. Results display beneath the search fields, as shown below.
Click the icon in the Select column (shown in screenshot above) for the applicable sponsor contact record in the result list to add that sponsor contact to distribution for the invoice document.
To add a new sponsor contact, click the Add a new Contact to the Master List button. The Sponsor Contact: Details popup opens for creation of the new contact record, as shown below.
Enter contact details and click the Save Sponsor Contact Info button. The contact record is added to the sponsor record and the Sponsor Contact: Details popup closes.
Note: If the study is not associated to a sponsor, it is not possible to add a sponsor contact.
To add other system users to distribution for the invoice document, click the Add additional recipients button. The Search User Directory page opens (shown below).
Enter desired search criteria in the Last Name, First Name or by Department fields and click the Find button to run the search. Results are listed in a table beneath the search form.
To add one user from the result list to distribution for the invoice document, click the icon in the Select User column for the applicable recipient. To add multiple users from the result list to distribution for the invoice document, select the Check for Multiple checkbox for each applicable recipient, then click the Save Selected User(s) button. The user(s) is/are added to the Additional Recipients list (see example screenshot below).
Back on the Board Invoice Recipients page, click the Send to selected recipients button at the upper right of the page (see screenshot below) to send the invoice document to everyone on the distribution list.
The invoice document is sent, the Board Invoice Recipients page closes and the Submission Invoice page displays.
Click the Add a New Payment button above the Invoice Payments section to enter a payment against an invoice.
The Invoice Payment Details popup opens for entry of payment details, as shown below.
Enter the amount received and date received, then click the Save Changes to Invoice button to save the payment entry. The Amount Received is automatically deducted from the outstanding balance for the invoice.
The payment is added to the Invoice Payments table on the Submission Invoice page, as shown below.
To delete a payment from the Invoice Payments table, click its corresponding icon in the Delete column.
Click the icon in the Edit column to open the corresponding payment record for editing.
Click the icon in the View Payment Doc column to view a read-only version of the payment document supplied for the corresponding payment.
When the cumulative Amount Received for the invoice equals the Balance Due for the invoice, the invoice is closed. Enter the Complete Date and change the default selection of “No” for Complete to “Yes” to move the closed invoice to the Complete tab.
Incomplete Tab
Invoices with an outstanding balance due remaining are listed on the Incomplete tab.
Click the icon in the Open column to open the associated record in the Submission Invoice page (example shown below). This page is where new charges or payments can be applied to the invoice, and the invoice can be marked Complete when applicable.
Notice that this is the same page used when an invoice is initially created from the Not Invoiced tab of the Board Invoice History page. See the Invoice History > Not Invoiced tab of this manual for full details of the Submission Invoice page, including processing instructions for Invoice Documents and Invoice Payments.
Complete Tab
Recall that when the cumulative Amount Received for an invoice equals the Balance Due for the invoice, the invoice is closed and moves to the Complete tab.
Click the icon in the Open column to open the associated record in the Submission Invoice page. See the Invoice History > Not Invoiced Tab section of this manual for full details of Submission Invoice page fields and functionality.
Reports
The Reports link provides access to boilerplate reports for the IRB Assistant module.
See the Reports manual for more information about this feature.
Submission Forms
The Submission Forms link opens the Submission Forms page.
The Submission Forms page provides access to all non-study Submission Forms available to the IRB, as well as a list of Outstanding Submission(s) for these forms.
The left side of the screen provides a Submission Forms section. Click the name of a form in this list to open it in the form library, where all versions of the form available in the system are accessible. Options are available to Copy Form, Add a New Form, Compare Two Versions if more than one version of a form is available, and Delete Selected Form(s) that have not yet been submitted.
The Outstanding Submission(s) section of the page lists outstanding submissions of non-study submission forms in the system. Click the Routing in Progress icon in the Track Location column to open the Workflow - Submission Tracking page for the form, as shown below.
Click Back to close the Workflow - Submission Tracking page and return to the Submission Forms screen.
To view a read-only copy of the form, click the name of the form in the Request Type column.
To edit the form, click the Retract Submission button. The button changes to read Send Submission. Open the form again to revise it. After making and saving desired changes to the form, exit the form and click the Send Submission button to re-submit the form.
Review Board Administration
The Review Board Administration menu is used to set up configuration lists, define outcome letters and invoices, define meeting agenda and minutes templates, and set up automatic review board related notifications.
See the IRB Assistant – Review Board Administration manual for more information about these features.