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’s system setup contains properties that the Administrator can set within the Review Board to configure board functionality. Before changing these properties, it is a good idea to have a working knowledge of what you want in your system and to verify your needed changes with iMedRIS personnel.
The properties are divided into categories, displayed on the left panel of the screen. To view the properties in a category, click the category in the left panel, and all the properties related to that category will appear on the right side 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. 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 (through IRB Assistant). |
|---|---|
| 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 Pediatric Risk Assigned Configuration List. Note: If the Study Board Property rb.use_child_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 will automatically change to the study status Inactive – Administratively Closed one year to the date of the IRB 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 will display in the Master Lay Summary Label in the General Information tab of the submission. In the submission, that text will display in this label. |
| rb.nofity_use_continuing_review_due | When this property is set to Yes, then the Continuing Review Notifications will be based off of 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 will determine the number of days that a non-System/Review Board Administrator will be able to unlock the submission after it has been marked as completed. Thereafter only System or Review Board Administrators will be able to lock/unlock the submission from the General Information tab. |
| rb.restrict_change_of_rb_number | This property will turn on or off the ability to modify the IRB Number field in the Pre-Review Screening tab. To see the IRB Number field, rb.use_rb_number must be set to Yes. If rb.restrict_change_of_rb_number is also set to yes, the field will be grayed out. To modify the IRB Number, you would need to visit the Study Summary Profile page. |
| rb.restrict_user_training_to_board_member | When this property is turned on, the system will display all training records for board members attached to the board. If this property is turn off, then the system will display all training records for all the user setup in the iMedRIS system. |
| rb.stamp_no_clinic_use | When set to Yes, this creates a watermark on a Study Document when the review board approves it, saying “Not for Clinicians Use”. |
| rb.use_auto_expiration | Automatically expires a study when the IRB expiration date arrives if this property is set to Yes. |
| rb.use_auto_select_PI_and_Contact | The Principal Investigator and Study Contact will automatically be 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 will turn on the ability to check off submission components to include in an email 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 email will only send if indicated. The workflow step is “Send E-mail with Selected Components (Selected in Review Board).” In 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, you can 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 will not be available. |
| rb.use_continuing_review_notif_when _full_renewal | If your review board is using Full Renewal Expiration for studies, you can 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 will 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 IRB numbers for studies be unique. If this property is No, the system will not allow you to enter a duplicate IRB 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_rb_number | This property will turn on or off the IRB Number field in the Pre-Review Screening tab. If it is set to Yes, the IRB Number field will populate. |
| rb.use_revise_last_approved_app_on_change_personnel | 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” the applied filters even after the user leaves the RB Submissions page will remain. It also affects other areas of the system like the Analyst Dashboard. When the analyst leaves the analyst dashboard page and then returns, the filters will still be applied. |
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.stamp_study_doc | Turns on or off the iRIS document stamp for Study Documents. If this property is Yes, you will be able to indicate under the Study Document Outcome/Outcome Configuration List 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 Yes. When you go to the bulk approval area, the Expiration Date will be disabled. Setting this property to No will enable the ability to provide an Expiration Date in this 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 IRB can attach Study Documents; however, in the list of Study Documents, only documents that have previously been submitted will appear in the list. If this property is set to Yes, any Study Document added to the study record will display and be attachable by the IRB. |
Study Summary Info
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_project_proposal_number | Setting this property to Yes allows the review board to change the project proposal number field, (rb.use_project_number 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: 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 property must be on) |
| rb.allow_change_of_study_radiation_use | Setting this property to Yes allows the review board to change 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: This does not require the study to attach a consent form to a submission, but is used 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.use_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. |
| 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 in order for this field to display on the page. The property system.use_study_project_number must be set to Yes under 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. *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 Yes to this property controls the appearance of the Revise/Attach column in the table of Submission Components on the Submission Components/Submission Complete tabs of a submission. The An |
| rb.allow_submission_doc_add | This property will allow you to attach a Consent form or other Study Document to a submission in the Submission Components tab. When this property is set to No, the Add New Component button will not appear on the page. |
| rb.allow_submission_doc_delete | This property will allow you to remove a document from a submission in the Submission Components tab. When this property is on, then the user will be able to detach certain attachments from the submission by clicking the red X next to the item. When the property is set to No, the Unattached column will not display, and you will not be able to detach documents. |
rb.auto_assign_analyst_on_response | When this property is set to Yes, then the Assigned Analyst that was previously assigned to a submission that was returned for corrections will automatically be 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 will be 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 will display. When this property is set to No, the Master Lay Summary will 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 will display. 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 this property is set to yes, the Expiring Study Notification will also be sent to the PI/Study Contact. If the property is set to “No”, then it will be sent to the assigned analyst. If there is no analyst assigned, the notification will be sent to the coordinator(s). |
| rb.use_agenda_state | This property determines if the agenda state will be displayed at the top of the meeting agenda screen. If this property is set to Yes, the Agenda State and Reviewer Notifications will be displayed. If this is set to No, the Agenda State and Reviewer Notifications will not be displayed. |
|---|---|
| rb.use_autocal_expiration | Use this property to control when the IRB 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 IRB Expiration Date will populate with a date. If this property is set to No, the IRB Expiration date will not automatically populate with a 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 will populate in the Study Personnel table. |
| rb.use_Continuing_Review_notification_if_IRB_Record_NO | If this property is set to Yes, then the ability for notifications to be sent even though the IRB is not the IRB of Record has been added. |
| rb.use_coord_view_all_comments | This property will allow your IRB analyst to share comments with all reviewers conducting a review. This property works together with 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 | When approving a submission, this property will allow you to restrict setting a study expiration date 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 an Initial Review or Continuing Review, the Review Cycle and IRB Expiration Date will be grayed out. If the property is set to No, you will have the ability to set the Review Cycle and IRB Expiration Date for any submission you are approving. |
| rb.use_expiration_calculation_restriction_initial_review_only | When approving a submission, this property will allow you to restrict setting a study expiration date to only Initial Reviews. If this property is set to Yes and you are setting Outcome information for a submission that is not an Initial Review, the Review Cycle and IRB Expiration Date will be grayed out. |
| rb.use_meeting_approval_date | Setting this property to Yes will enable a Meeting Approval Date in the Outcome tab. The Meeting Approval Date will allow you to specify an approval date that is different than the actual approval date for the submission. Using the Meeting Approval Date will cause the IRB 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 | This property turns Off/On meeting functionality. If this property is set to Yes, then the Review Board will be able to conduct meetings within iRIS. If this property is set to No, meeting functionality will be turned off. If you turn this property off, you will need to open the Define Role Access matrix, save it, log out, and then log back in to make the changes effective in the system. Additionally, when the property is turned back on, you will need to return to th Review Board Define Role Access matrix and grant access to the meeting options in iRIS again. |
| rb.use_member_checklist | This property turns On/Off the Member Checklist functionality in the Review Checklist and Comments tab. If this property is set to No, the member checklist will be turned off. If this property is set to Yes, then the Review Board will be able to use the member checklist, and the Add Member Checklist 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 | This property turns On/Off the Member Comments functionality in the Review Checklist and Comments tab. If the property is set to No, this feature will be turned off. If the property is set to Yes, board members can add comments using the Add Member Comments button. |
| rb_use_Continuing_Review_notification_if_IRB_Record_NO | When this property is set to “Yes”, it allows board members to select if they want their board to send continuing review notifications to the KSP, even if they are not the board of Record. If a board member answer “No” to the field “IRB of Record”, then the field “Use Continuing Review Notifications to KSP” will be prompted. If the board member answers “Yes” to the field “IRB of Record” then the field “Use Continuing Review Notifications to KSP” will not appear. If this property is set to “No” the field “Use Continuing Review Notifications to KSP” will never be prompted, even if a board member answers “No” to the field “IRB of Record”. |
| rb.use_nonhuman_subject_research | This property turns on and off the appearance of the Non-Human Subject Research (NHSR) flag on the Outcome 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 | When this property is set to Yes, the review board has the ability to indicate whether the meeting date when selecting a Full Committee Review is a required field in for the Review Process. |
| rb.use_restore_context_for_administrative | This property controls whether to restore the context on return from a response when previously processed as Process Administratively. |
| rb.use_restore_context_for_committee_agenda | This property controls whether to restore the context on return from a response when previously processed from a 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 on, then there will appear an icon next to each question in the form that the reviewer can click to add comments. Comments can then be merged into stipulations, the submission discussion, and outcome letters through the Review Summary tab. When this property is off, then 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. |
| rb.use_review_recommendations | This property controls the appearance of the Recommendation tab in the Submission Processing screens. |
| rb.use_review_stipulations | This property controls the appearance of the Stipulations tab in the Submission Processing screens. |
| rb.use_review_summary | This property controls the Review Summary tab in the Submission Processing screens. |
| rb.use_reviewer | When this property is turned on and the Review Assignment is set for a Submission, then a field will populate below the Review Process that allows you to add a reviewer. When this property is off, then this field will not populate. Turning this property off will also disable functionality in the Review Checklist and Comments page. You will not be able to see the Reviewer Checklist table on this screen. |
| rb.use_reviewer_coi_flag | This property controls the appearance of the “Has COI?” column in the table of reviewers on the Pre-Review Screening tab. The column will display “Yes” when an assigned reviewer either has a reported conflict of interest with the study’s sponsor or is key study personnel. |
| 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_study_followup | Displays a Study Follow-up field in the Study Profile and Outcome tab, allowing the review board to specify a date for when the study follow-up date will be. |
| rb.use_submission_by_committee | If your review board queue needs to be separated into committee submissions, use this prerty. Committee Submissions mean that a submission will be assigned to a committee within the review board instead of the entire review board. If a submission is assigned to a committee, none of the other committees within the board will 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 Submissions 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 will indicate which committee they are in. 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 Submissions queue. |
| rb.use_submission_letters | This property turns on/Off the review boards Submission Received Notification Letter section in the Submission Processing screens. If this property is set to Yes, the Submission Received Notification Letter tab will be turned on. If this property is set to No, the Submission Received Notification Letter tab will be turned off. |
| rb.use_submission_outstanding_board_tasks | When this property is set to Yes, the Outstanding Board Tasks tab will be displayed on the submissions page. When selected, it will show all outstanding board submission tasks. |
| 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 will populate and you will be able to specify how each member voted. |
| 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. *Note: If you turn this property on, you will need to set role access under Review Board Administration > Setup Role Access. When this property is set to No, the Internal Submission Routing tab will 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. When this property is set to Yes, then you will be able to assign a role. *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. |
Consent Processing
The following properties are related to Informed Consent uploads.
PROPERTY | DESCRIPTION |
|---|---|
rb_allow_to_attach_any_consent | Turns on or off the ability to attach non-submitted Consent Forms. If this property is set to No, the IRB can attach Informed Consents; however, in the list of Consent Documents, only documents that have previously been submitted will appear in the list. If this property is set to Yes, any Consent Document added to the study record will display and be attachable by the IRB. |
Reviewers
The reviewer properties control different elements of the Reviewer Assignments in the IRB Review Board.
| PROPERTY | DESCRIPTION |
|---|---|
| rb.reviewers_form_completes_submission | When this property is set to Yes, when the reviewer assigned to a submission completes their review, it will also complete the submission (assuming the Reviewer’s form has the Reviewer’s Indication of Completion data value). Please note that if multiple reviewers were assigned, the submission will be completed after the first reviewer completes their review. |
| rb.copy_previous_reviewer_form | This property is used in conjunction with rb.use_previous_submission_reviewers. If rb.use_previous_submission_reviewers is set to Yes and this property 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 will copy the contents of the old reviewer checklist into the new assignment. When the Reviewer accesses their new assignment, the Reviewer Checklist will already be populated with the same answers they applied before. If rb.copy_previous_reviewer_form is set to No, the system will still assign the previous reviewers, but their checklist will not copy the previous data over. |
| rb.number_days_to_notify_reviewers | This value signifies the number of days prior to a meeting that 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 will send. |
| rb.restrict_KSP_from_reviewers | This property, when set to Yes, will restrict KSP from the drop-down list of Reviewers to choose from. When set to no, the members will be included in the list of Reviewers regardless of whether they are KSP on the study. |
| rb.restrict_reviewer_to_voting_member | When this property is set to Yes, then the drop-down list of available reviewers will be restricted to voting members on the current committee. If this property is set to No, then the non-voting members of the committee will also be included in the list of available reviewers. |
| 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, the reviewer will be directed to the Review Checklist and Comments tab instead of the Reviewer Checklist when the Reviewer Assignment home screen task is opened. If this property is set to No, the Reviewer Checklist will open when the home screen task is opened, unless the Reviewer Checklist for the board has not been defined. In that case, the Review Checklist and Comments tab will open. |
| rb.use_shared_comments | This property allows reviewers to share their comments within a Reviewer’s Form. Navigating to the Reviewer’s Form, then clicking on the desired submission form, routes reviewers to view the submission form. When a reviewer clicks on the comment icon, an ajax window to add a comment is prompted. At the bottom of the ajax window, there is an option which allows users to display their comment to other reviewers. Once this selection is made and saved, the comment is added and the background for the given comment turns blue. This color conversion allows other reviewers assigned to that submission form to easily identify a shared comment by another user. |
| rb.use_designated_reviewer | If you would like to use Designated Review as a Review Process in iRIS, set this property to Yes. This will enable 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 will not display in the review process list. |
| rb.use_reviewer_panel | This property enables the Reviewer Panel functionality. If this property is set to “Yes”, the Reviewer Panel button will populate 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 will not be accessible. |
| 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 Assign Reviewers table in the Pre-Review Screening tab, an Add Previous Reviewers button will populate. When clicked, the system will reassign the reviewers assigned to the last round of the submission. If this property is set to No, the button will not populate, and you can manually add reviewers by clicking on the Add Reviewer button. |
| rb.use_reviewer_signoff_sheet | This property will allow 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 will be presented with a signoff sheet at the end of the Reviewer Checklist. When the reviewer approves and applies an electronic signature, the review will be considered complete. If the reviewer denies the signoff sheet, the review task will remain open until the signoff is approved. If this property is set to No, the system will behave 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 will cut 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 will include 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 will not be 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 will hide reviewer checklists on the Review Checklist and Comments tab from board members if they are not the reviewer assigned on a submission. If this property is set to Yes, all members of the board will be 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 will look at this property to determine the date to pull into this field. The default value is “7,” meaning that when the notification sends, the merge code will populate with the date 7 days from today. Example: Today is 7/16/2016. The merge code for a notification sent today would populate with “7/23/2016”. If you would like the date that populates in the merge code to base itself off a different number, change the value in this property. |
| rb.use_reviewer_outcome_data_values | When this property is set to Yes, certain fields within the Reviewer Checklist will merge into the Outcome tab. The data values are listed in Form Designer under the data type Outcome Tab Merge Fields. The four fields, Review Outcome, Submission Approval Date, Review Cycle, and Risk Assigned will display in the application once set-up in Forms Designer. When the reviewer saves this section of the checklist, the values saved here will also post to the Outcome tab for the reviewed submission. Note: The corresponding review board must have the property set to Yes for its Reviewer Checklist. For example, set the property to Yes within the IRB Review Board Configuration Options in order to enable this functionality within the IRB Reviewer Checklist. It is advised that this functionality be enabled only for processes that include one reviewer per submission. If more than one reviewer is presented with the merged fields, the data will be overwritten with the most current save of the Reviewer Checklist. These data types can be used one time within the Reviewer Checklist. They can only be used in one section. These values are linked directly to the Outcome tab. When they are updated, the Outcome tab is updated and the information in the checklist is current and reflects the current outcome of the submission. Once this information updates the Outcome tab, there is no reset to the previous values set in the Outcome tab. Data from the checklist will override the current data in the Outcome tab. Reviewer Checklists using this feature are assumed to be completed before a board meeting, if full board, and before the analyst completes the Outcome tab, if expedited. |
Meeting Settings
Meeting Settings are properties related to review board meetings.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.generate_meeting_in_days | This property indicates how many days worth of meetings the system will generate when you create a recurring meeting schedule within Meeting Manager. The default setting for this property is 365, meaning that iRIS will generate a year’s worth of meetings. If you would like the system to generate more or less meeting dates, change the number of days 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, you can use this property to enable this functionality. In the Meeting Manager, you will have the ability to Generate an Expedite Report in the same way that you can generate an agenda document. When the Expedited Report is published, it will be available to view on the Meeting Agenda page. When this property is set to No, you will not be able to generate an Expedited Report. You can pull in Expedited submissions to 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 will populate in a Voting Members Absent group in the Meeting Attendance area. If this property is set to No, no Voting Members Absent group will populate. |
| 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 will populate in a Non-Voting Members Absent group in the Meeting Attendance area. If this property is set to No, no Non-Voting Members Absent group will populate. |
| 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 will populate in a Staff Absent group in the Meeting Attendance area. If this property is set to No, no Staff Absent group will populate. |
Security
Security properties allow you to define whether or not 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 | When this property is set to Yes, the KSP of a study who are also review board members will not be able to open their associated submissions from the Submissions queue or via Find a Study under IRB Assistant. If the KSP attempts to open the submission or the study via the review board, an error message will appear.
|
| 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 will populate in the results. If this property is set to No, all studies in the database can be searched and accessible by the review board. |
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 will handle them.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.update_recommendation_by_all | Allow board members to update recommendations. If this property is set to No, then the members cannot update recommendations. If this is set to Yes, then a button will appear to give board members the ability to update the recommendations. This option is only applicable if rb.use_review_recommendations is set to Yes. |
| rb.update_stipulation_by_all | Allow board members to update stipulations. If it is set to No, then the members cannot update the stipulations. If this is set to Yes, then a button will appear to allow the board members the ability to update the stipulations. This option is only applicable if rb.use_review_stipulations is set to Yes. |
| 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 are able to 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 with the Stipulation that Must be Addressed type, the Send Bundle Email button 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 will always be available in the Submission Complete tab, regardless of what kind of Stipulations have been created for the submission. |
| rb.use_stipulation_category | This property will allow you to create categories for your Stipulations. When set to Yes, you can set up the categories in Review Board Administration – List Configuration and Maintenance – Stipulation Categories. When you are creating Stipulations for a Submission, you will be able to 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 will set 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 Yes, then if a stipulation is added to a submission, then 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 will say Yes or No depending on the Outcome selected. |
| rb.use_stipulation_responses_display_all_boards | When this property is set to Yes, then the Stipulations with the response from the previous submission will appear under the Stipulation tab. If it is set to No, this section will not appear. |
| rb.use_stipulation_tracking | Stipulations Tracking is a tool within the review board assistant 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 will populate called Stipulations Tracking. You may need to enable this area within Role Access when you initially turn on the property. If this property is set to No, the Stipulations Tracking area will not populate within the review board assistant. |
Study Board Properties
Study Board Properties allow you to indicate whether particular fields should appear on the Outcome tab and the Study Summary.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_adult_benefit_assigned | When this is set to Yes, then the Adult Benefit Assigned field will display in the Outcome tab and Study Summary page of a submission. When set to No, this field will not display. These lists are configurable in the List Maintenance Setup tab of the Review Board Administration. |
| rb.use_adult_risk_assigned | When this is set to Yes, then the Adult Risk Assigned field will display in the Outcome tab and Study Summary page of a submission. When set to No, this field will not display. These lists are configurable in the List Maintenance Setup tab of the Review Board Administration. |
| rb.use_archived_location | When this property is set to Yes, then the Archived Location field will populate in the Study Summary screen of a submission. When set to No, this field will not display. These lists are configurable in the List Maintenance Setup tab of the Review Board Administration. |
| rb.use_ceded_review_details | When this property is set to Yes, then the Ceded Review Detail fields will populate when the user selects to the question “is ceded from” Yes or No option in the Outcome tab and Study Summary page. When set to No, the ceded details will not display when the user selects the Yes radio button for the question “is Ceded From.” |
| rb.use_child_risk_assigned | When this is set to Yes, then the Pediatric Risk Assigned field will display in the Outcome tab and Study Summary page of a submission. When set to No, this field will not display. These lists are configurable in the List Maintenance Setup tab of the RB admin. |
| 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, then the Continuing Review Due field will display in the Outcome tab and Study Summary page of a submission. When this is set to no, this field will not display. |
| rb.use_controls_approved | When this property is set to Yes, then the Controls Approved field will display in the Outcome tab of a submission along with the Study Summary/Profile screen. When set to No, this field will not display. |
| rb.use_dod_outcome_labels | When this property is set to Yes, the system will use DOD-related terms within the Outcome tab. When this property is set to No, the system will not use DOD-related term within the Outcome tab but will use general terminology. |
| rb.use_expiration_date | When this property is set to Yes, the IRB Expiration field will display in the Outcome tab and the Study Summary of a submission. When set to No, this field will not display. |
| rb.use_irb_assent | When this property is set to Yes, then the IRB Assent field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_irb_continuing_review _expedited_category | When this property is set to Yes, then the Continuing Review Expedited Review Category field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_irb_documentation_of_consent | When this property is set to Yes, then the Documentation of consent field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_irb_exempt_category | When this property is set to Yes, then the Exempt field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_irb_expedited_category | When this property is set to Yes, then the Expedited Review Category field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_irb_hipaa | When this property is set to Yes, then the HIPPA field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_irb_investigational_device_use | When this property is set to Yes, then the Investigational Device field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_irb_investigational_drug_use | When this property is set to Yes, then the Investigational Drug field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_irb_minor_risk_assessment | When this property is set to Yes, then the Children Risk Assessment field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_irb_risk_level | When this property is set to Yes, then the Risk Level field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_irb_waiver_of_consent | When this property is set to Yes, then the Waiver of Consent field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_last_continue_review_approved | When this property is set to Yes, then the Last Continuing Review Approved field will display in the Outcome tab of the submission along with the Study Summary Screen. The date will populate with a read-only version of the Last Continuing Review form that was approved. When set to No, this field will not display. |
| rb.use_parental_permission | When this property is set to Yes, then the Parental Permission field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_pregnant_women | When this property is set to Yes, then the Pregnant Women/Fetuses/Neonates field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_prisoners | When this property is set to Yes, then the Prisoners field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_problem_deviation_noncompliance | When this property is set to Yes, then the Problem/Deviation/Non-Compliance field will display in the Outcome tab of a submission along with the Study Summary screen. When set to No, this field will not display. |
| rb.use_regulatory_determination1 | This property enables the Regulatory Determination 1 configuration list that can be configured under the List Maintenance Setup tab of the Review Board Administration screen. This list will then be available to choose from when setting an Outcome and in the Study Summary for an IRB submission. When set to No, this field will not display. |
| rb.use_regulatory_determination2 | This property enables the Regulatory Determination 2 configuration list that can be configured under the List Maintenance Setup tab of the Review Board Administration screen. This list will then be available to choose from when setting an Outcome and in the Study Summary for an IRB submission. When set to No, this field will not display. |
| rb.use_risk_assigned | When this is set to Yes, then the Risk Assigned field will display in the Outcome tab and Study Summary page of a submission. When set to No, this field will not display. This list is configurable in the List Maintenance Setup tab of Review Board Administration. |
| 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_surrogates_consent | When this property is set to Yes, then the Surrogate consent field will display in the Outcome tab of a submission, along with the Study Summary screen. |
| 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_comments | When this property is set to Yes, the Termination Comments option 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. |
| rb.use_termination_reason | When this property is set to Yes, the Termination Reason dropdown list will be available on the Outcome tab of the submission processing screens, as well as the Study Summary. When set to No, this field will not display. |
| rb.use_ward | When this property is set to Yes, the Wards field will be available on the Outcome tab of the submission processing screens, as well as the Study Summary. When set to No, this field will not display. |
Amendments
Amendment properties allow you to control functionality related to amending IRB studies.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_append_amendment_on_rb_number | When this property is set to yes, then the IRB number will be appended with the number/letter associated with the last amendment version provided. |
| rb.user_letter_for_amendment_version | When this property is set to Yes, you can enter letters as well as numbers for the amendment version 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 in Review Assignment for a submission. You will be 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 Review Process “Assign to Review Committee Agenda.” If this property is set to Yes, you will 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 will not be available. | ||
| rb.use_review_process_emergency_use | This property is related to the Review Process “Emergency Use.” If this property is set to Yes, you will have the option to assign the submission to Emergency Use in the Pre-Review Screening tab. If this is set to No, this option will not be available. | ||
| rb.use_review_process_exempt | This property is related to the Review Process “Exempt.” If this property is set to Yes, you will have the option to assign the submission to Exempt in the Pre-Review Screening tab. If this is set to No, this option will not be available. | ||
| rb.use_review_process_expedited | This property is related to the Review Process “Expedited.” If this property is set to Yes, you will 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 will not be available. | ||
| rb.use_review_process_facilitated | This property is related to the Review Process “Facilitated Review.” If this property is set to Yes, you will have the option to assign the submission to Facilitated Review in the Pre-Review Screening tab. If this is set to No, this option will not be available. | ||
| rb.use_review_process_forward | This property is related to the Review Process “Pre-Review Forward to Another Board/Committee.” If this property is set to Yes, you will 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 will not be 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 the Study Classification and Risk Assigned columns 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_identifying_codes | Setting this property to Yes, will allow the user to be able to customize codes to be used for submissions to be able to identify characteristic of a protocol easily. The codes can be configured and implemented in the three sections, Submissions and Analyst Dashboard as well as the General Information tab on the IRB board in submissions processing. When set to “Yes By setting this to “Yes”, a new link called Setup Submissions code to edit the codes will be visible to the Administrator under the Review Board System Setup. |
| 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 require an electronic signature for an Internal Routing task.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_signature_on_internal_routing | You can use this property to control whether or not to require a user’s electronic signature when completing an Internal Routing task. If this property is set to Yes, then an electronic signature will be required on an Internal Routing task. When this property is set to No, the User ID and Password fields will not populate 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. |
© iMedRIS Data Corporation