Please note: A PDF version of this guide is available for download at the bottom of the article.
Within Review Board Administration is a link to Board Configuration Options. This area of the review board contains items that the Administrator can set within the Review Board to configure certain functionality. Before changing these properties, it is a good idea to have a working knowledge of what you want in your system and is also a good idea to verify your needed changes with iMedRIS personnel.
The properties are divided into categories and these categories are displayed on the left panel of the screen. To view the properties in a category, simply click the category in the left panel and all the properties related to that category will appear in the rest of the screen. “Yes” or “No” radio buttons indicate that the properties are on/off properties and any other value indicates that the property is a variable.
Board Setup
The following properties are related to general review board functionality.
| PROPERTY | DESCRIPTION |
|---|---|
| rb.allow_adult_benefit_assigned_list | This property controls the appearance of the Adult Benefit Assigned Configuration List under Review Board Administration > List Maintenance Setup. Note: If the Study Board Property rb.use_adult_benefit_assigned is set to No, the list will not appear regardless of this property setting. |
| rb.allow_adult_risk_assigned_list | This property controls the appearance of the Adult Risk Assigned Configuration List. Note: If the Study Board Property rb.use_adult_risk_assigned is set to No, the list will not appear regardless of this property setting. |
| rb.allow_change_of_business_associate_list | This property controls the appearance of the Business Associate List. |
| rb.allow_change_of_business_associate_type | This property controls the appearance of the Sponsor Type list. |
| rb.allow_change_of_device_list | This property controls the appearance of the Device Configuration List. |
| rb.allow_change_of_drug_list | This property controls the appearance of the Drug Configuration List. |
| rb.allow_change_of_study_status | If you would like to allow the review board to modify the study status, set this property to “Yes”. Ingredients In the IACUC Assistant, if this property is set to “Yes,” you will be able to modify the study status in the Study Profile for studies you open via Find a Study. |
| rb.allow_change_of_study_status_list | This property controls the appearance of the Protocol Status Configuration List. |
| rb.allow_child_risk_assigned_list | This property controls the appearance of the Risk Assigned Configuration List. Note: If the Study Board Property rb.use_risk_assigned is set to No, the list will not appear regardless of this property setting. |
| rb.allow_document_outcome_list | This property controls the appearance of the Protocol Document Outcome/Outcome Configuration List. |
|---|---|
| rb.allow_issue_reporting_list | This property controls the appearance of the Issue Reporting Types list. |
| rb.allow_regulatory_determination1_list | This property controls the appearance of the Regulatory Determination 1 List. Note: If the Study Board Property rb.use_regulatory_determination1 is set to No, the list will not appear regardless of this property setting. |
| rb.allow_regulatory_determination2_list | This property controls the appearance of the Regulatory Determination 2 List. Note: If the Study Board Property rb.use_regulatory_determination2 is set to No, the list will not appear regardless of this property setting. |
| rb.allow_review_outcome_list | This property controls the appearance of the Review Outcome/Outcome Configuration List. |
| rb.allow_reviewer_rank_list | This property controls the appearance of the Reviewer Rank Configuration List. |
| rb.allow_risk_assigned_list | This property controls the appearance of the Risk Assigned Configuration List. Note: If the Study Board Property rb.use_risk_assigned is set to No, the list will not appear regardless of this property setting. |
| rb.allow_termination_reason_list | This property controls the appearance of the Termination Reason List. |
| rb.Auto_expire_exempt_protocols | If this property is set to “Yes” then any study that is noted as Exempt automatically changes to the study status Inactive – Administratively Closed one year to the date of the IACUC Expiration date. |
rb.display_date_board_rec_column | If this property is set No, then the Date Board Received column will not display throughout the system. |
| rb.Edit_Master_Lay_Summary | Allows the review board to change the master lay summary of the study in the General Information tab on a submission. |
| rb.Master_Lay_Summary_Label | This property is a text field and the value put into the field displays in the Master Lay Summary label on a submission. In the submission, that text displays in this label. |
| rb.nofity_use_continuing_review_due | When this property is set to “Yes,” then Continuing Review Notifications are based off the Continuing Review Due Dates set in the Outcome tab of a submission rather than the Review Board Expiration Date. |
| rb.number_of_days_to_lock_submission | The value entered here determines the number of days that a non-System/Review Board Administrator can unlock the submission after it has been marked as completed. Thereafter, only System or Review Board Administrators can lock/unlock the submission from the General Information tab.
|
| rb.restrict_change_of_rb_number | This property turns on or off the ability to modify the IACUC Number field in the Pre-Review Screening tab. If it is set to “Yes” and rb.use_rb_number is set to “Yes”, the IACUC Number field is grayed out. To modify the IACUC Number, you need to visit the Study Summary Profile page. |
| rb.restrict_user_training_to_board_member | When set to “Yes,” the list of users that display within IACUC Assistant > User Training is limited to only users that have a role within the IACUC review board. When set to “No,” User Training will list all user accounts in iRIS. |
| rb.stamp_no_clinic_use | When set to “Yes,” this creates a watermark on a study document when the review board approves it, stating “Not for Clinicians’ Use.” |
| rb.use_auto_expiration | When set to “Yes,” automatically sets a study to expired, depending on the configuration of the study status, when the expiration date arrives. |
| rb.use_auto_select_PI_and_Contact | The Principal Investigator and Study Contact are automatically selected as recipients in Correspondence or an Outcome Letter generated within a submission when this property is set to “Yes.” |
| rb.use_bundle_to_external_source | This property turns on the ability to check off submission components to include in an E-mail bundle. If this property is turned on, you must also set up a step in the workflow. This step is to be placed immediately after your review board queue, but the E-mail only sends if indicated. The workflow step is “Send E-mail with Selected Components (Selected in Review Board).” On the Submission Complete tab of the submission processing screens, an extra column, Indicate Items to bundle, populates for Outcome Letters and Submission Components. Before completing the Submission, select items to include in the bundle email and then click the Send Bundle Email button at the top of the page. If this property is set to “No,” this functionality is not available. |
| rb.use_continuing_review_notif_when _full_renewal | If your review board is using Full Renewal Expiration for studies, turn this property to “Yes” to send the Continuing Review Notifications on the Full Renewal date for the study. |
| rb.use_create_study | Displays the Add a new Study menu group in the RB assistant If this property is set to “Yes,” you need to also turn on the functionality in the Role Matrix for roles on the board. |
| rb.use_duplicate_rb_number | This property will allow you to specify that IACUC numbers for studies be unique. If this property is No, the system will not allow you to enter a duplicate IACUC number on the Study Summary Profile page or the Pre-Review Screening tab when rb.use_rb_number is set to Yes. |
| rb.use_full_expiration_calculation | When this property is turned on, calculation which allows users with board administration access to modify the way the system calculates the study expiration date, was created within Review Board Administration > Board Configuration Options > Board Setup for all iRIS modules. When the rb.use_full_expiration_calculation property is set to "Yes", the system will set the study expiration date to the exact date of the expiration of the study, and the study will expire right when the next date begins. For example, if the Submission Approval date is set to 07/09/2018, and a annual review cycle is selected, the system will set the “IRB Expiration Date/Status Check Due Date” at 7/9/2019 |
| rb.use_full_renewal_expiration | This property turns on the Full Review Expiration date field within the Outcome tab and the Study Profile. |
| rb.use_rb_number | This property turns on or off the IACUC Number field in the Pre-Review Screening tab. If it is set to “Yes,” the IACUC Number field populates. |
| rb.use_revise_last_approved_app_on_change_personne | When this property is set to “Yes”, and there is a change in KSP and the board approves the KSP change, a new version of the application is created to reflect the newly updated KSP. When this property is set to “No”, a new version of the application will not be created when the board approves KSP. |
| rb.use_sticky_filters | When this property is set to “Yes” filters that are applied will remain set even if the user leaves the page and returns to the same page. Note: When this property is set on, it will affect the Board Submissions page and the Analyst Dashboard page Search Criteria. |
Document Processing
The following properties are related to Study Document uploads.
| PROPERTY | DESCRIPTION |
|---|---|
| rb.allow_bulk_approval | Turns on or off the ability to approve multiple documents at once in the Submission Components or Submission Complete tab. Set this property to “Yes” to enable bulk approvals. |
| rb.allow_change_of_document_version_date | Turns on and off the ability for the review board to change the document version date when reviewing documents from the Submission Components tab. When this property is set to “Yes,” Version Date will be an editable field. |
| rb_allow_to_attach_any_document | Turns on or off the ability to attach non-submitted Study Documents. If this property is set to “No”, the review board can attach Study Documents; however, in the list of Study Documents, only documents that have previously been submitted appear in the list. If this property is set to “Yes,” any Study Document added to the study record displays and is attachable by the review board. |
| rb.stamp_study_doc | Turns on or off the iRIS document stamp for Study Documents. If this property is set to “Yes,” you are able to indicate whether a certain Study Document Outcome should convert the document and stamp it with the Electronic Document Stamp. |
|---|---|
| rb.use_no_expiration_for_document_approval | You can disable the Expiration Date from Study Documents by setting this property to “No.” When you go to the bulk approval area, the Expiration Date is disabled. Setting this property to “Yes” enables the ability to provide an Expiration Date in this field. |
Study Summary Info
The properties in this list control the display and use of certain study-related fields in the Study Profile. Properties in this list that begin with ‘rb.use_’ turn on the field read-only in the Study Profile for the review board, unless otherwise noted.
The properties in this list that begin with ‘rb.allow_change_of’ allow the review board to modify that particular field within the Study Profile (you must also have the corresponding ‘rb.use_’ property turned on for this functionality).
Properties must also be used by the study. Properties are first turned on in System Administration > System Configuration > Study Profile. Then if the review board desires to see what the study has input for a particular field, the corresponding ‘rb.use_’ property must be turned on in this group. Finally, if the review board desires to view and change the field as applicable, the corresponding ‘rb.allow_change_of’ property must be turned on.
| PROPERTY | DESCRIPTION |
|---|---|
| rb.allow_change_of_emergency_use | Setting this property to “Yes” allows the review board to change the emergency use field to Yes or No. (rb.use_emergency_use must be on) |
| rb.allow_change_of_fda_regulated | Setting this property to “Yes” allows the review board to change the FDA Regulated field to Yes or No. (rb.use_fda_regulated must be on) |
| rb.allow_change_of_ind_ide | Setting this property to “Yes” allows the review board to change the IND/IDE field to Yes or No. (rb.use_ind_ide must be on) |
| rb.allow_change_of_study_accrual_ceiling | Setting this property to “Yes” allows the review board to change the study accrual ceiling. (rb.use_study_accrual_ceiling must be on) |
| rb.allow_change_of_study_accural_target | Setting this property to “Yes” allows the review board to change the study accrual target. (rb.use_study_accural_target property must be on) |
| rb.allow_change_of_study_alias | Allows the review board to change the Study Alias. Note that this field may be called something different in your system depending on system labels. The Study Alias is also known as the Study Nickname or Study Number. |
|---|---|
| rb.allow_change_of_study_blinding_method | Setting this property to “Yes” allows the review board to change the study’s blinding method. (rb.use_study_blinding_method must be on) |
| rb.allow_change_of_study_classification | Setting this property to “Yes” allows the review board to change the study classification (rb.use_study_classification must be on) |
| rb.allow_change_of_study_coordinating_number | Setting this property to “Yes” allows the review board to change the study coordinating number. (rb.use_study_coordinating_number must be on) |
| rb.allow_change_of_study_ctep_number | Setting this property to “Yes” allows the review board to change the study CTEP number. (rb.use_study_ctep_number must be on) |
| rb.allow_change_of_study_current_enrollment | Setting this property to “Yes” allows the review board to change the current enrollment in the study. (rb.use_study_current_enrollment must be on) |
| rb.allow_change_of_study_finance_role | Setting this property to “Yes” allows the review board to change the finance role of the study. (rb.use_study_finance_role must be on) |
| rb.allow_change_of_study_keywords | Setting this property to “Yes” allows the review board to change the study keywords. (rb.use_study_keywords must be on) |
| rb.allow_change_of_study_peds_category | Setting this property to “Yes” allows the review board to change the pediatrics category of the study. (rb.use_study_peds_category must be on) |
| rb.allow_change_of_study_phase | Setting this property to “Yes” allows the review board to change the phase of the study. (rb.use_study_phase must be on) |
| rb.allow_change_of_study_project_number | Setting this property to “Yes” allows the review board to change the study’s project number. (rb.use_project_number must be on) |
| rb.allow_change_of_study_radiation_use | Setting this property to “Yes” allows the review board to change of the radiation use of the study. (rb.use_study_radiation_use must be on) |
|---|---|
| rb.allow_change_of_study_research_type | Setting this property to “Yes” allows the review board to change the study’s research type. (rb.use_study_research_type must be on) |
| rb.allow_change_of_study_storage_code | Setting this property to “Yes” allows the review board to change the study storage code. (rb.use_study_storage_code must be on) |
| rb.allow_change_of_study_therapeutic_area | Setting this property to “Yes” allows the review board to change the therapeutic area designated for the study. (rb.use_study_therapeutic_area must be on) |
| rb.allow_change_of_study_title | Setting this property to “Yes” allows the review board to change the study title. |
| rb.allow_change_of_study_va_number | Setting this property to “Yes” allows the review board to change the study’s VA number. (rb.use_study_va_number must be on) |
| rb.display_study_management_enrollments | Setting this property to Yes will display the current Enrollments and Accrual Target values to display on the General Information page within Submission Processing. |
| rb.use_consent_form_required | Displays a Yes/No selection in the Study Profile. When this property is set to “Yes” the review board has the ability to indicate whether a consent is required on this study. Note that this does not require the study to attach a consent form to a submission but is for reporting purposes. |
| rb.use_ct_indicator | Displays a Yes/No selection in the Study Profile. When this property is set to “Yes” the review board has the ability to indicate whether Clinical Trials is associated to this study. |
| rb.use_emergency_use | Displays a Yes/No label in the Study Profile indicating if the study is an Emergency Use. |
| rb.use_fda_regulated | Displays a Yes/No label in the Study Profile indicating if the study is FDA regulated. |
| rb.use_federally_funded | Displays a Yes/No field in the Study Profile indicating if the study is Federally Funded. |
| rb.final_meeting_date | Displays a Final Meeting Date field in the Study Profile, allowing the review board to specify a date for when the last meeting date for the study was held. |
| rb.use_first_meeting_date | Displays a First Meeting Date field in the Study Profile, allowing the review board to specify a date for when the first meeting date for the study was held. *This property does not apply to COI. |
| rb.use_genetic_testing | Displays a Yes/No selection in the Study Profile. When this property is set to “Yes,” the review board has the ability to indicate whether Genetic Testing is used on this study. |
| rb.use_ind_ide | Displays a Yes/No label in the Study Profile indicating if the study uses an IND/IDE. |
| rb.use_PHI_disclosed | Displays a Yes/No selection in the Study Profile. When this property is set to “Yes,” the review board has the ability to indicate whether the study is PHI disclosed or not. |
| rb.use_pi_initiated | Displays a Yes/No selection in the Study Profile. When this property is set to “Yes,” the review board has the ability to indicate whether the study is PI-initiated or not. |
| rb.use_project_number | Displays the project number of the study. *Note, the system must be set up to use the Project Number in iRIS for this field to display on the page. The property system.use_study_project_number must be set to “Yes” in System Administration > System Configuration > Study Default Settings, in addition to the property described here being set to “Yes,”. |
| rb.use_accrual_ceiling | Displays the study’s accrual ceiling. |
| rb.use_accrual_target | Displays the study’s accrual target. |
| rb.use_blinding_method | Displays the study’s blinding method. |
| rb.use_study_classification | Displays the study classification. |
| rb.use_study_coordinating_number | Displays the study coordinating number. |
| rb.use_study_ctep_number | Displays the study’s CTEP number. |
| rb.use_study_current_enrollment | Displays the current subject enrollment in the study. |
| rb.use_study_enrollment | Displays the number of subjects enrolled in the study. The number displayed here will populate with the actual number of subject records enrolled on the study if using Subject Management. Note: This property is not applicable unless using Subject Management. |
| rb.use_study_finance_role | Displays the study finance role field. |
| rb.use_study_keywords | Displays the study keywords. |
| rb.use_study_peds_category | Displays the pediatrics category associated with the study. |
| rb.use_study_phase | Displays the phase of the study. |
| rb.use_study_radiation_use | Displays the radiation use field. |
| rb.use_study_research_type | Displays the research type of the study. |
| rb.use_study_storage_code | Displays the storage code of the study. |
| rb.use_therapeutic_area | Displays the therapeutic area associated with the study. |
| rb.use_study_va_number | Displays the study’s VA Number. |
Submission Review Properties
These properties are related to processing submission forms in the Submissions queue.
| PROPERTY | DESCRIPTION |
|---|---|
| rb.allow_submission_component_revise | Setting this property to “Yes” turns on the Revise/Attach column for submission components. The icons in this column allow the review board to revise submission components as well as attach submission components that the study has revised since the submission was made. |
| rb.allow_submission_doc_add | This property allows you to attach a Study Document to a submission in the Submission Components tab. When this property is set to “No,” the Add New Component button does not appear on the page. |
| rb.allow_submission_doc_delete | This property allows you to remove a document from a submission in the Submission Components tab. When this property is on, the user is able to delete certain attachments by clicking the red X next to the item. When the property is set to “No,” you are not be able to delete any attachments in the Submission Components tab. |
| rb.auto_assign_analyst_on_response | When this property is set to “Yes,” then the Analyst that was previously assigned to a submission that was returned for corrections is automatically assigned to the Return Response Submission. Note: This property is paired with the Return Response Action in the Workflow. When this action is put into the workflow for the Review Response Submission Form, then this property is effective. |
|---|---|
| rb.display_master_study_summary | This property controls the display of the Master Lay Summary in the General Information tab of a submission. When this property is set to “Yes,” the Master Lay Summary displays. When this property is set to “No,” the Master Lay Summary does not display in the General Information tab. |
| rb.display_submission_summary | This property controls the display of the Submission Summary in the General Information tab of a submission. When this property is set to “Yes,” the Submission Summary displays. When this property is set to “No,” the Submission Summary will not display in the General Information tab. |
| rb.override_component_lock | When this property is set to Yes, submission components added by an initial board are unlocked such that the next board in the workflow can view all components. |
| rb.send_expiring_study_notification_to PI_contact | When a study expires within the review board, an Expiring Study Notification triggers and sends to the IACUC Coordinators so they can take proper action on the study within iRIS. This property allows you to specify whether or not the same notification should send to the PI and Study Contact on the study as well. When this property is set to “Yes,” the PI and Study Contact are included in the list of recipients on the Expiring Study Notification. If this property is set to “No,” the notification sends only to the IACUC Coordinators. Note: The property rb.use_auto_expiration must be set to “Yes” in order to use the Expiring Study Notification and for the system to use the auto-study expire feature. |
| rb.use_agenda_state | This property determines if the Agenda State is displayed in the meeting agenda screen. If this property is set to “Yes,” the Agenda State and Reviewer Notifications are displayed. If this is set to “No,” the Agenda State and Reviewer Notifications are not displayed. |
| rb.use_autocal_expiration | Use this property to control when the IACUC Expiration Date populates with a date in the Outcome tab. If this property is set to “Yes,” as soon as you select a Submission Approval date and a Review Cycle, the IACUC Expiration Date populates with a date. If this property is set to “No,” the IACUC Expiration date will not populate with a date and the coordinator processing the submission needs to manually assign an IACUC Expiration Date. |
| rb_use_conflict_tracking | This property turns on or off the Study Personnel COI Tracking panel in the General Information tab in the submission processing screens. If this property is set to “Yes,” the COI Under Review column populates in the Study Personnel table. |
| rb.use_coord_view_all_comments | This property allows your review board analyst to share comments with all reviewers conducting a review. This property works together with the Submission Comments for All Reviewers data value. Using the two together allows the Analyst to merge comments into the reviewer form so assigned reviewers can access the comments while conducting their review. |
| rb.use_expiration_calculation_restriction | This property allows you to restrict setting a study expiration date when approving a submission to only Initial Reviews and Continuing Reviews. If this property is set to “Yes” and you are setting Outcome information for a submission that is not the type Initial Review or Continuing Review, the Review Cycle and IACUC Expiration Date is grayed out. If the property is set to “No,” you can set the Review Cycle and IACUC Expiration Date for any submission you are approving. |
| rb.use_expiration_calculation_restriction_initial_review_only | This property restricts a study expiration date when approving an Initial Review Submission form. |
| rb.use_meeting_approval_date | Setting this property to “Yes” enables a Meeting Approval Date in the Outcome tab. The Meeting Approval Date allows you to specify an approval date that is different than the actual approval date for the submission. Using the Meeting Approval Date causes the IACUC Expiration Date to calculate based off of this field as opposed to the Submission Approval Date. |
| rb.use_meeting_vote_summary | This property determines whether anonymous voting will be used for meetings. If this property is set to Yes, anonymous voting will be used. If this property is set to No, anonymous voting will not be used in meetings. |
| rb.use_meetings | Turns Off/On meeting functionality. If this property is set to “Yes” then the Review Board is able to conduct meetings within iRIS. If this property is set to “No,” meeting functionality will be turned off. If this property is turned off, you need to save the Define Role Access matrix, log out, and log back in to make the changes effective in the system. Additionally, when the property is turned back on, you need to return to the Review Board’s Define Role Access matrix and turn on access to meetings again. |
| rb.use_member_checklist | Turns On/Off member checklist functionality in the Review Checklist and Comments tab. If this property is set to “No,” the member checklist is turned off. If this property is set to “Yes” then the Review Board will be able to use the member checklist, and a button will appear at the top of the Review Checklist and Comments tab allowing members to create and complete a checklist. |
| rb.use_member_comments | Turns On/Off the member comments in the Review Checklist and Comments tab. If the property is set to “No,” this feature is turned off. If the property is set to “Yes,” member comments will be available in the Review Checklist and Comments tab. |
| rb.use_outcome_letter | This property will turn on or off the ability to create and send Outcome Letters in the system. If the property is set to “No,” this feature will be turned off. The Outcome Letter tab will not be available in the Submission Processing Screens. If this property is set to “Yes,” the Outcome Letter feature will be available for use. |
| rb.use_past_meetings | You can set this property to restrict the ability to add a Submission to a past meeting. Set this property to “Yes” and you will be able to add an item to a past meeting. Set the property to “No” to restrict this ability. |
| rb.use_require_meeting_date_for_board_review | Setting this property to Yes, will make the meeting date for the Assigned to Review Committee Agenda board review a required field. |
| rb.use_restore_context_for_administrative | This property controls whether to restore the context on return from a response when previously processed administratively. |
| rb.use_restore_context_for_committee_agenda | This property controls whether to restore the context on return from a response when previously processed as Committee Agenda. |
| rb.use_restore_context_for_designated_reviewer | This property controls whether to restore the context on return from a response when previously processed as Designated Review. |
| rb.use_restore_context_for_emergency_use | This property controls whether to restore the context on return from a response when previously processed as Emergency Use. |
| rb.use_restore_context_for_exempt | This property controls whether to restore the context on return from a response when previously processed as Exempt. |
| rb.use_restore_context_for_expedited | This property controls whether to restore the context on return from a response when previously processed as Expedited. |
| rb.use_restore_context_for_facilitated | This property controls whether to restore the context on return from a response when previously processed as Facilitated. |
| rb.use_restore_context_for_limited_review | This property controls whether to restore the context on return from a response when previously processed as Limited Review. |
| rb.use_review_comments | This property turns on or off the ability for reviewers to add comments when examining submission forms. When a reviewer views a submission form and this property is set to “Yes,” an icon appears next to each question in the form. When clicking this icon, the reviewer can add comments. Comments can then be merged into stipulations as needed through the Review Summary tab. When this property is set to “No, “these icons will not appear in the submission forms. Note: this property does not enable the ability to comment within the Research Application. See rb.use_review_comments_ro for this ability. |
| rb.use_review_comments_ro | This property turns on or off the ability for reviewers to add comments when examining the research application (from section 4.0 onwards). When a reviewer views an application and this property is set to No, then the icon will appear next to each question in the form. When clicking this icon, the reviewer can add comments. Comments can then be merged into stipulations, the submission discussion, and outcome letters through the Review Summary tab. When this property is on, then these icons will not appear in the application form. |
| rb.use_review_discussion | This property controls the appearance of the Submission Discussion tab in the Submission Processing screens If this property is set to “No,” the Submission Discussion tab does not display. |
| rb.use_review_recommendations | This property controls the appearance of the Recommendation tab in the Submission Processing screens. If this property is set to “No,” the Recommendation tab does not display. |
| rb.use_review_stipulations | This property controls the appearance of the Stipulation tab in the Submission Processing screens. If this property is set to “No,” the Stipulation tab does not display. |
| rb.use_review_summary | This property controls the Review Summary tab in the Submission Processing screens. If this property is set to “No,” the Review Summary tab does not display. |
| rb.use_reviewer | When this property is set to “Yes” and the Review Assignment is set for a Submission, then a field populates below the Review Process that allows you to add a reviewer. When this property is set to “No,” then this field does not populate. Turning this property off also disables functionality in the Review Checklist and Comments page. You are not able to see any Reviewer Checklists tables on this screen. |
| rb.use_reviewer_coi_flag | When this property is set to Yes, the COI column displays the COI column in the Assign Reviewer section in the Pre-Review Screening tab. |
| rb.use_show_restore_context_on_response_for_administrative | Controls whether the “Restore context on response” field is displayed when the “Process Administratively” review process is selected. |
| rb.use_show_restore_context_on_response_for_committee_agenda | Controls whether the “Restore context on response” field is displayed when the “Committee Agenda” review process is selected |
| rb.use_show_restore_context_on_response_for_designated_reviewer | Controls whether the “Restore context on response” field is displayed when the “Designated Reviewer” review process is selected. |
| rb.use_show_restore_context_on_response_for_emergency_use | Controls whether the “Restore context on response” field is displayed when the “Emergency Use” review process is selected. |
| rb.use_show_restore_context_on_response_for_exempt | Controls whether the “Restore context on response” field is displayed when the “Exempt” review process is selected. |
| rb.use_show_restore_context_on_response_for_expedited | Controls whether the “Restore context on response” field is displayed when the “Expedited” review process is selected. |
| rb.use_show_restore_context_on_response_for_facilitated | Controls whether the “Restore context on response” field is displayed when the “Facilitated Review” review process is selected. |
| rb.use_show_restore_context_on_response_for_limited_review | Controls whether the “Restore context on response” field is displayed when the “Limited Review” review process is selected. |
| rb.use_submission_by_committee | If your review board queue needs to be separated into committee submissions, use this property. Committee Submissions means that a submission is assigned to a committee within the review board instead of the review board. If a submission is assigned to a committee, none of the other committees within the board have access to the submission. iMedRIS recommends not setting this property without discussion with iMedRIS personnel beforehand. If this property is set to “Yes,” the review board will be split into committees. Each committee will have its own Submission queue and the committees cannot access submissions to other committees unless the user associated to one committee is also associated to the other committee. Additionally, when a user is in the Committee Submissions screen, the heading at the top of the page indicates in which committee they are. Note, if using this functionality, you will need to modify your workflow so that the submission is directed to a specific committee rather than the review board. If the property is set to “No,” the committees are related to one review board and work as one Submission queue. |
| rb.use_submission_vote_summary | This property controls whether voting for a Submission will be anonymous. If this property is set to “Yes,” anonymous voting will be used. If this property is set to “No,” anonymous voting will not be used for the Submission. Instead, the name of each voting member present at the meeting populates and you can specify how each member voted by name. |
| rb.useReviewRouting | This property controls the Internal Submission Routing tab within the submission processing screens. When this property is set to “Yes,” the Internal Submission Routing tab displays. When this property is set to “No,” the Internal Submission Routing tab does not display within the Submission Processing screens. |
| rb.useReviewRouting_user_role | This property allows you to control whether or not you would like to specify a role when assigning a user to an Internal Routing Assignment. When this property is set to “Yes,” then you can assign a role in Internal Routing. Note: You will need to configure the roles under Review Board Administration > List Maintenance Setup >Internal Routing User Roles. When set to “No,” a role cannot be assigned. This property does not apply if the rb.useReviewRouting property is turned off. |
Reviewers
The reviewer properties control different elements of the Reviewer Assignments in the Review Board.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.copy_previous_reviewer_form | This property is used in conjunction with rb.use_previous_submission_reviewers. If this property is set to “Yes” and rb.use_previous_submission_reviewers is set to “Yes,” when you choose to assign previously assigned reviewers to a Pre-Review Correction Form or a Review Response Form, the system copies the contents of the old reviewer checklist into the new assignment. When the Reviewers access their new assignment, the Reviewer Checklist is already populated with the same answers they applied before. If rb.copy_previous_reviewer_form is set to “No,” the system still assigns the previous reviewers, but their checklist does not copy the previous data over. |
| rb.nav_reviewers_directly_to_checklist | When this property is set to “Yes,” the reviewer will be directed to the Reviewer Checklist form when the Reviewer Assignment home screen task is opened. Note: rb_nav_reviewers_directly_to_comments_tab needs to be set to No for this property to apply. |
| rb.nav_reviewers_directly_to_comments_tab | When this property is set to “Yes,” a reviewer is directed to the Reviewer Checklist and Comments tab within the Submission Processing screens as opposed to being directed to the Reviewer Checklist. When this property is set to “No,” the reviewer is directed into the Reviewer Checklist when the homepage task is opened. |
| rb.number_days_to_notify_reviewers | This value signifies the number of days prior to a meeting before a reviewer notification is sent. A value of -1 = ignore. This property can be any whole, non-negative number (excluding -1). The number specified represents the number of days before a meeting that the notification sends. |
| rb.restrict_reviewer_to_voting_member | When this property is set to “Yes,” then the dropdown list of available reviewers is restricted to voting members on the current committee. If this property is set to “No,” then the non-voting members of the committee are also included in the list of available reviewers. |
| rb.reviewers_form_completes_submission | When this property is set to “Yes,” when the reviewer assigned to a submission completes their review, it also completes the submission (assuming the Reviewer’s form has the Reviewer’s Indication of Complete data value). If this property is set to “No,” when the reviewer completes their review, the assigned Analyst is responsible for setting Outcome information and completing the submission. |
|---|---|
| rb.use_designated_reviewer | If you would like to use Designated Reviewer as a Review Process in iRIS, set this property to “Yes.” This enables the review process “Designated Reviewer.” From here, you can assign the submission to a meeting and assign a designated reviewer. If this property is set to “No,” the “Designated Reviewer” option does not display in the review process list. |
| rb.use_previous_submission_reviewers | This property allows you to assign previously assigned reviewers to a submission. When this property is set to “Yes,” when a submission comes back into the review board queue that has been previously assigned to reviewers in the Pre-Review Screening tab - Assign Reviewers table, an Add Previous Reviewers button populates. When clicked, the system reassigns the reviewers assigned to the last round of the submission. If this property is set to “No,” the button does not populate, and you can manually add reviewers by clicking on the Add Reviewer button. |
| rb.use_reviewer_panel | This property enables the Reviewer Panel functionality. If this property is set to “Yes,” the Reviewer Panel button populates within the Reviewer Checklist, allowing the reviewer to access the panel. If this is set to “No,” then this button will not be displayed, and the Reviewer Panel is not accessible. |
| rb.use_reviewer_signoff_sheet | This property allows you to use a signoff page similar to signoffs for submission forms. When this property is set to “Yes,” instead of a Reviewer Indication of Completion value in a Reviewer Checklist, the reviewer is presented with a signoff sheet at the end of the Reviewer Checklist. When the reviewer approves and applies an electronic signature, the review is considered complete. If the reviewer denies the signoff sheet, the review task remains open until the signoff is approved. If this property is set to “No,” the system behaves in the normal function, allowing the reviewer to indicate they are complete with their review within the form. |
| rb.use_shortened_reviewer_comments | This property cuts off Rank and Item Number when comments are merged from the Review Summary into the Submission Discussion or the Outcome Letter. When the property is set to “Yes,” the merged comments appear without the Rank and Item Number. When the property is set to “No,” the merged comments appear with the Rank and Item Number. |
| rb.use_study_assigned_reviewers | This property includes any study role assigned reviewers that have been set up in the workflow for signoff in the list of Reviewers to choose from. When this is set to “No,” then the study role assigned users are not included in the drop-down list of available reviewers when adding a reviewer in the Pre-Review Screening tab. |
| rb.use_view_of_reviewers_for_members | This property hides reviewer checklists from members if they are not the reviewer assigned on a submission. If this property is set to “Yes,” all members of the board are able to view each other’s checklists. If this property is set to “No,” members not assigned as reviewers will not be able to see reviewer checklists. |
| rb.x_calendar_days | This property works in conjunction with the “X calendar days from today” merge code that is available in certain review board notifications. When this merge code is inserted into a notification and the notification is sent, this merge code looks at this property to determine the date to pull into this field. The default value is “7,” meaning when the notification sends, the merge code populates with the date 7 days from today. Example: today is 7/16/2014. The merge code for a notification sent today populates with “7/23/2014”. If you would like the date that populates in the merge code to base itself off a different number of days, change the value in this property and the change will take effect. |
Meeting Settings
Meeting Settings are properties related to meetings in the review board. These properties are related to the display of members absent on the meeting page and how many meetings iRIS should generate in the Meeting Schedule.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.generate_meeting_in_days | This property indicates how many days worth of meetings the system generates when you create a recurring meeting schedule within Meeting Manager. The default setting for this property is 365, meaning iRIS generates a year’s worth of meetings based on the criteria of the recurring meeting. If you would like the system to generate more or less, change the number in this field. |
| rb.use_expedited_report | If your review board would like to keep expedited submissions in a separate report attached to a meeting page, use this property to enable this functionality. If the property is set to “Yes,” you will be able to set up an Expedite Report template in Review Board Administration, much like an agenda or minutes template. In the Meeting Manager, you have the ability to Generate an Expedited Report in the same way you generate the agenda document. When the Expedite Report is published, it is available to view on the Meeting Agenda page. When this property is set to “No,” the expedite report information is not available and you can pull Expedited Submissions into the main body of the Agenda and Minutes templates. |
| rb.use_member_absent | This property allows you to control the display of voting members absent on the Meeting Agenda page. When this property is set to “Yes,” any voting member not marked as present at the meeting populates in a Voting Members Absent group in the Meeting Attendance area. If this property is set to “No,” any voting member not marked as present at the meeting will simply not show up on the Meeting page. |
| rb.use_non_member_absent | This property allows you to control the display of non-voting members absent on the Meeting Agenda page. When this property is set to “Yes,” any non-voting member not marked as present at the meeting populates in a Non-Voting Members Absent group in the Meeting Attendance area. If this property is set to “No,” any non-voting member not marked as present at the meeting simply does not show up on the Meeting page. |
| rb.use_staff_absent | This property allows you to control the display of staff absent on the Meeting Agenda page. When this property is set to “Yes,” any staff not marked as present at the meeting populates in a Staff Absent group in the Meeting Attendance area. If this property is set to “No,” any staff not marked as present at the meeting, simply does not show up on the Meeting page. |
Security
Security properties allow you to define whether the review board should be able to search for studies not associated to the review board and if you want to allow KSP to access submissions if they also have a role on the board.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.restrict_access_from_KSP | This property restricts the KSP of a study to open the study on the board side if the user also has a review board role. If the property is set to “No,” the KSP access is not restricted. If the property is set to “Yes,” the KSP access is restricted and an error message appears if the KSP attempts to open the study from the review board (see below).
|
| rb.restrict_find_to_rb | This property restricts the access to studies that do not belong to the review board. If this property is set to “Yes,” in Find a Study, only studies that have an association to the review board populate in the results. If this property is set to “No,” all studies in the database are searchable and accessible by the review board in Find a Study. |
Multi-site Setup
These properties are related to multi-site studies and their setup.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.site_submissions_are_synced_to_core | This property allows multi-site studies to have the studies IRB Number Appended to the core IRB. Therefore, the Core IRB number will be the same as the Site’s IRB Number. |
Recommendations and Stipulations
These properties are related to stipulations and how the system handles them.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.update_recommendation_by_all | Allow members to update recommendations. If it is set to “No,” then reviewers cannot update the recommendations. If this is set to “Yes,” then a button appears to allow the reviewers the ability to update the recommendations. This option does not apply if rb.use_review_recommendations is off. |
| rb.update_stipulation_by_all | Allow members to update stipulations. If it is set to “No,” then members cannot update the stipulations. If this is set to “Yes,” then a button appears to allow the reviewers the ability to update the stipulations. This option is irrelevant if rb.use_review_stipulations is off. |
| rb.use_bundle_stipulation | This property is only applicable if rb.use_bundle_to_external_source is set to “Yes.” If both properties are set to “Yes,” you can choose to bundle selected submission components in the Submission Complete tab when returning a submission for Pre-Review Changes or Review Response, but only if you are returning the submission without any Stipulation Type 1 (Stipulations That Must be Addressed) created in the Stipulations tab. If there are any Stipulations created of the Stipulation that Must be Addressed type, the Send Bundle Email will not populate on the page. If rb.use_bundle_to_external_source is set to “Yes” and rb.use_bundle_stipulation is set to “No,” the Send Bundle Email button is always available in the Submission Complete tab, regardless of what kind of Stipulations have been created for the submission. |
|---|---|
| rb.use_stipulation_category | This property allows you to create categories for your Stipulations. When set to “Yes,” you can setup the categories in Review Board Administration > List Configuration and Maintenance > Stipulation Categories. When you are creating Stipulations for a Submission, you can associate the stipulation to a category. If this property is set to “No,” you will not have the ability to associate a category to a Stipulation. |
| rb.use_stipulation_control_response | This property sets the review board submissions to default to return to the study for corrections if there are any Stipulations added to the submission. If this property is set to “Yes” and a stipulation is added to a submission, the Additional Information Required field in the Outcome tab of the submission will always say “Yes,” regardless of the submission outcome selected. Additionally, if there are no stipulations added to the submission, then the Additional Information Required field will always say “No,” regardless of the outcome selected. When this property is set to “No,” then the Additional Information Required field reads “Yes” or “No” depending on the Outcome selected. |
| rb.use_stipulation_responses_display_all_boards | This property allows the board members to view stipulations sent to different boards for a single submission within the Stipulation tab of a submission. When a study responds to a stipulation and returns the submission to the Review Board, the submission will populate in the stipulation tab and will include other stipulations made by other board for the same submission. Note: The stipulations displaying from different boards will be Read-only. Users will only be able to take action towards stipulation in their system only. |
|---|---|
| rb.use_stipulation_tracking | Stipulations Tracking is a tool within the Review Board that allows you to track outstanding stipulations and view previously closed stipulations. If this property is set to “Yes” a new area within the Review Board Assistant populates called Stipulations Tracking. You may need to enable this area within the Role Access when you initially turn on the property. If this property is set to “No,” the Stipulations Tracking area does not populate within the Review Board Assistant. |
Study Board Properties
Study Board Properties are basic study elements specific to the review board.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_archived_location | When this property is set to “Yes,” then the Archived Location field populates in the Study Summary screen of a submission. When set to “No,” this field does not display. These lists are configurable in the List Maintenance Setup tab of Review Board Administration. |
| rb.use_audit_view | This property controls whether to allow user to view the audit data for lists. For example, a study application list. |
|---|---|
| rb.use_continue_review | This property controls whether to use continuing review for the board. |
| rb.use_continue_review_due | When this property is set to “Yes,” the Continuing Review Due field populates within the Study Profile and the Outcome tab of a submission. |
| rb.use_expiration_date | When this property is set to “Yes” the Expiration Date field populates within the Study Profile and the Outcome tab of a submission. |
| rb.use_last_continue_review_approved | When this property is set to “Yes” the Last Continuing Review Approved field populates within the Study Profile and the Outcome tab of a submission. |
| rb.use_study_closure | When this property is set to yes, the Study Closure field will display in the outcome tab and the study summary of the submission. When set to No, this field will not display. |
| rb.use_temp_closure_end | When this property is set to Yes, the Temporary Closure End field will be available on the Outcome tab of the submission processing screens, as well as the Study Summary. |
| rb.use_temp_closure_start | When this property is set to Yes, the Temporary Closure Start field will be available on the Outcome tab of the submission processing screens, as well as the Study Summary. |
| rb.use_termination_date | When this property is set to Yes, the Temporary field will be available on the Outcome tab of the submission processing screens, as well as the Study Summary. |
Amendments
Amendment properties allow you to indicate whether an IACUC number should append with an added number or letter each time a study is amended.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_append_amendment_on_rb_number | When this property is set to “Yes,” then the IACUC number is appended with the last amendment version provided. |
| rb.use_letter_for_amendment_version | When this property is set to “Yes,” you can enter a letter as the amendment version, rather than a number, on the Outcome tab of the submission processing screens. |
| rb.use_protocol_version_tracking | When this property is set to Yes, you can amend the protocol number, indicating a new version of the protocol, when an amendment form is processed by the board. This option will be availble for use on the Outcome tab of the submission processing screens. |
Submission Pre-review
Properties in this group relate to the Review Process set for a submission. You are able to turn on or off certain review processes, depending on the review board type.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_review_process_agenda | This property is related to the “Full Committee Review” Review Process. If this property is set to “Yes,” you have the option to assign a submission to a Review Committee Agenda on the Pre-Review Screening tab of the submission. If this is set to “No,” this option is not available. |
| rb.use_review_process_emergency_use | This property is related to the “Emergency Use” Review Process. If this property is set to “Yes,” you have the option to assign the submission to Emergency Use on the Pre-Review Screening tab. If this is set to “No,” this option is not available. |
| rb.use_review_process_exempt | This property is related to the “Exempt” Review Process. If this property is set to “Yes,” you have the option to assign the submission to Exempt in the Pre-Review Screening tab. If this is set to “No,” this option is not available. |
| rb.use_review_process_expedited | This property is related to the “Expedited” Review Process. If this property is set to “Yes,” you have the option to assign a submission as an Expedited Review in the Review Assignment tab of a submission. If this is set to “No,” this option is not available. |
|---|---|
| rb.use_review_process_facilitated | This property is related to the “Facilitated Review” Review Process. If this property is set to “Yes,” you have the option to assign the submission to Facilitated Review in the Pre-Review Screening tab. If this is set to “No,” this option is not available. |
| rb.use_review_process_forward | This property is related to the “Forward to Another Board/Committee” Review Process. If this property is set to “Yes,” you have the option to forward the submission to another board or committee in the Pre-Review Screening tab. If this is set to “No,” this option is not available. |
| rb.use_review_process_limited_review | This property is related to the Review Process “Limited Review” If this property is set to Yes, you will have the option to assign the submission to Limited Review in the Pre-Review Screening tab. The new review process will run the same as the “Expedited” and “Process Administratively” processes. |
Letter
Letter properties are in place to help control default selected recipients on Outcome letters.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_auto_select_Study_Coordinator | When set to yes, this property will automatically select the Study Coordinator when sending an Outcome Letter within a submission. |
| rb.use_default_recipient_not_selected | This property will allow you to determine whether the recipient list for outcome letters is, by default, all selected or all unselected. If this property is set to Yes, then the recipient’s checkbox will not automatically be selected.
|
Submissions
Use the properties in the Submissions group to control the display of Study Classification and Risk Assigned in the Submissions queue.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_department_displayed | If set to Yes, the Risk Assigned column will display on the Not Assigned and Assigned tabs of the Submissions queue. If set to No, the column will not display. |
| rb.use_risk_assigned_displayed | If set to Yes, the Risk Assigned column will display on the Not Assigned and Assigned tabs of the Submissions queue. If set to No, the column will not display. |
| rb.use_study_classification_displayed | If set to Yes, the Study Classification column will display on the Not Assigned and Assigned tabs of the Submissions queue. If set to No, the column will not display. |
Notification
Notification properties allow you to indicate what type of notifications the assigned analyst should receive for a submission’s completed tasks.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_internal_routing_complete_queue | When this property is set to Yes, then the Assigned Analyst for a submission will get a task appearing in their home screen notifying them that the Internal Submission Routing has been completed. If this property is set to No, then the task will not appear on the home screen. |
| rb.use_outcome_signoff_complete_queue | When this property is set to Yes, then the Assigned Analyst for the submission will get a task appearing on their home screen notifying them that the Outcome Letter Signoff has been completed. If this property is set to No, then the task will not appear on the home screen. |
| rb.use_reviewers_complete_queue | When this property is set to Yes, then the Assigned Analyst for the submission will get a task appearing in their home screen notifying them that all Reviewers have completed their review. If this property is set to No, then the task will not appear in the home screen. |
Fee Tracking
This property is used to indicate whether or not IRB Invoicing will be used within this review board.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_rb_invoicing | This property will enable the ability to use the IRB Invoicing feature. See the IRB Invoicing documentation for more information about configuration and use of this feature.
|
Internal Routing
Internal Routing allows you to specify whether or not to capture an electronic signature for an Internal Routing task.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_signature_on_internal_routing | Use this property to control whether or not to capture a user’s electronic signature when completing an Internal Routing task. If this property is set to “Yes,” then an electronic signature is required on an Internal Routing task. When this property is set to “No,” the User ID and Password fields are not populated on the page. |
Training
This property allows you to indicate whether or not to track training within this review board.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_training_tracking | This property will enable the Key Study Personnel’s review board-specific training to display in the General Information tab of the Submission Processing screens.
If this property is set to Yes, the training information will display in the Study Personnel table.
If this property is set to “No”, the training information will not display. |
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