Please note: A PDF version of this guide is available for download at the bottom of the article.
Within the Review Board Administration of the COI Assistant module is a link to Board Configuration Options. This link contains properties that the system administrator can set in order to obtain the desired functionality within the system. Before changing these properties, however, it is strongly advised to review this manual to learn more about the property settings, and it is advised that iMedRIS personnel be contacted for clarification as needed.
Once in Board Configuration Options, properties will be divided into categories on the left panel of the new screen. To view the properties in a category, simply click the category on the left panel, and all the properties related to that category will appear to the right of the screen (please see screenshot below). “Yes” or “No” radio buttons indicate that the properties are either on or off, whereas 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_change_of_study_status | To allow the review board to modify a study status, set this property to “Yes”. If this property is set to “Yes”, the review board will be able to modify the study status for a particular study in the Study Profile when using Find a Study. |
| rb.Auto_expire_exempt_protocols | If this property is set to “Yes”, any study noted as “Exempt” will automatically change to the study status “Inactive – Administratively Closed” one year to the date of the IRB Expiration date. *This property does not apply to COI. |
| rb.Edit_Master_Lay_Summary | This property allows the review board to make changes to the master lay summary of a study, located in the General Information tab of a submission. *This property does not apply to COI. |
| rb.Master_Lay_Summary_Label | This property allows the system administrator to change the text for the label “Master Lay Summary”. *This property does not apply to COI. In the example below, the default label “Master Lay Summary” was changed to “Study Abstract” using this property. |
| rb.nofity_use_continuing_review_due | When this property is set to “Yes”, the Continuing Review Notifications will be based off of the Continuing Review Due Date set on the Outcome tab of a submission, rather than the Review Board Expiration Date. *This property does not apply to COI. |
| rb.number_of_days_to_lock_submission | The value entered here will determine the number of days between a board submission receipt and when the submission is locked. The submission will have a button on the General Information tab allowing the System or Review Board Administrators to unlock it or lock it again. *This property does not apply to COI. |
| rb.restrict_change_of_irb_number | This property will turn on or off the ability to modify the IRB Number field on the Pre-Review Screening tab. *This property does not apply to COI. If set to “Yes” and the property rb.use_rb_number is also set to “Yes,” the IRB Number field will be disabled, restricting any changes to the IRB Number. If set to “No,” board members will be able to modify the system-assigned IRB Number within the Study Summary Profile page. |
| rb.stamp_no_clinic_use | When set to “Yes,” this property creates a watermark on Other Study Documents when the review board approves it. The watermark reads “Not for Clinicians Use.” *This property does not apply to COI. |
| rb.use_auto_expiration | A study is automatically set expired when the IRB expiration date arrives when this property is set to “Yes”. *This property does not apply to COI. |
| rb.use_auto_select_PI_and_Contact | The Principal Investigator and Study Contact will automatically be selected as recipients in Correspondence or Outcome Letters generated within a submission, when this property is set to “Yes”. *This property does not apply to COI. |
| rb.use_bundle_to_external_source | This property will turn on the ability to select submission components to be included in an email bundle. *This property does not apply to COI. If this property is turned on, you must also set up a step in the Workflow Designer, as the email will only send if indicated within the workflow. This step is to be placed immediately after the Review Board Queue step, using workflow step “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,” will populate in the table designated for Outcome Letters and Submission Components. Before completing the Submission, first select the items to be included in the bundle email, and then click Send Bundle Email button at the top of the page. If this property is set to “No,” the email bundle functionality will not be available. |
| rb.use_continuing_review_notif_when_full_renewal | If the review board is using Full Renewal Expiration for research projects, this property can be set to “Yes” in order to send Continuing Review Notifications upon reaching the Full Renewal date of a study. *This property does not apply to COI. |
| rb.use_create_study | When set to “Yes”, this property displays the “Add a new Study” menu group in the Review Board Assistant. *This property does not apply to COI. If this property is set to “Yes”, the functionality in the board’s Role Matrix will also need to be turned on, located in Review Board Administration – Setup Role Access. |
| rb.use_duplicate_rb_number | This property controls whether IRB Numbers should be unique. *This property does not apply to COI. If this property is set to No, the system will not allow saving a Study Summary Profile page with an already existing IRB Number. This property works assuming that the rb.use_rb_number property is set to “No,” or the rb.restrict_change_of_irb_number property is set to “Yes.” |
| rb.use_rb_number | This property will turn on or off the IRB Number field on the Pre-Review Screening tab. *This property does not apply to COI. If this property is set to “Yes”, the IRB Number field will populate. |
Study Summary Info
The properties in the list below control the display and use of certain study related fields within the Study Profile. Note that properties used by studies must first be turned on in System Administration > System Configuration > Study Profile. Once this functionality is turned on, the correlating properties in Board Configuration Options will take effect. In addition, in order to access the Study Profile, the review board must have Find a Study enabled. For more information on System Configuration options, please consult the iRIS System Administration manual.
Properties are easily identified and defined by the standard syntax they follow. Keep in mind, that some properties work hand-in-hand and these must be configured jointly. For example, properties that begin with “rb.use_” will turn on its correlating field, making the field visible in the Study Profile with read-only functionality (unless otherwise noted). Properties that begin with “rb.allow_change_of” will allow the review board to make modifications to a field as long as that specific field has already been turned on with a correlating “rb.use_” property. Additional information and guidelines will be provided in the tables that follow.
| 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. (Note that in order for this property to take effect, the rb.use_emergency_use property must also 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. (Note that in order for this property to take effect, the rb.use_fda_regulated property must also 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. (Note that in order for this property to take effect, the rb.use_ind_ide property must also be on) |
| rb.allow_change_of_study_accrual_ceiling | Setting this property to “Yes” allows the review board to change the study accrual ceiling. (Note that in order for this property to take effect, the rb.use_study_accrual_ceiling property must also be on) |
| rb.allow_change_of_study_accural_target | Setting this property to “Yes” allows the review board to change the study accrual target. (Note that in order for this property to take effect, the rb.use_study_accural_target property must also be on) |
| rb.allow_change_of_study_alias | Setting this property to “Yes” 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 referred to 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 blinding method. (Note that in order for this property to take effect, the rb.use_study_blinding_method property must also be on) |
| rb.allow_change_of_study_classification | Setting this property to “Yes” allows the review board to change the study classification (Note that in order for this property to take effect, the rb.use_study_classification property must also be on) |
| rb.allow_change_of_study_coordinating_number | Setting this property to “Yes” allows the review board to change the study coordinating number. (Note that in order for this property to take effect, the rb.use_study_coordinating_number property must also be on) |
| rb.allow_change_of_study_ctep_number | Setting this property to “Yes” allows the review board to change the study CTEP number. (Note that in order for this property to take effect, the rb.use_study_ctep_number property must also 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. (Note that in order for this property to take effect, the rb.use_study_current_enrollment property must also 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. (Note that in order for this property to take effect, the rb.use_study_finance_role property must also be on) |
| rb.allow_change_of_study_keywords | Setting this property to “Yes” allows the review board to change the study keywords. (Note that in order for this property to take effect, the rb.use_study_keywords property must also 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. (Note that in order for this property to take effect, the rb.use_study_peds_category property must also be on) |
| rb.allow_change_of_study_phase | Setting this property to “Yes” allows the review board to change the phase of the study. (Note that in order for this property to take effect, the rb.use_study_phase property must also 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. (Note that in order for this property to take effect, the rb.use_project_number property must also 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. (Note that in order for this property to take effect, the rb.use_study_radiation_use property must also 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. (Note that in order for this property to take effect, the rb.use_study_research_type property must also be on) |
| rb.allow_change_of_study_storage_code | Setting this property to “Yes” allows the review board to change the study storage code. (Note that in order for this property to take effect, the rb.use_study_storage_code property must also be on) |
| rb.allow_change_of_study_therapeutic_area | Setting this property to “Yes” allows the review board to make changes to the therapeutic area designated for the study. (Note that in order for this property to take effect, the rb.use_study_therapeutic_area property must also 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. (Note that in order for this property to take effect, the rb.use_study_va_number property must also be on) |
| rb.display_study_management_enrollments | Setting this property to “Yes” displays the study management enrollments. |
| rb.use_consent_form_required | This property displays a “Yes/No” radio button selection in the Study Profile. When this property is set to “Yes”, the review board has the ability to indicate whether a consent will be required on a particular study. *Note that this property is available for the use of reporting purposes only. The system does not apply an actual consent upload requirement. |
| rb.use_ct_indicator | This property displays a “Yes/No” radio button selection in the Study Profile. When this property is set to “Yes”, the review board has the ability to indicate whether Clinical Trials are associated to this study. |
| rb.use_emergency_use | When set to “Yes”, this property displays a “Yes/No” label in the Study Profile that will allow the review board to indicate whether the study is for Emergency Use purposes. |
| rb.use_fda_regulated | When set to “Yes”, this property displays a “Yes/No” label in the Study Profile that will allow the review board to indicate whether the study is FDA regulated. |
| rb.use_final_meeting_date | When set to “Yes”, this property displays a Final Meeting Date field in the Study Profile, allowing the review board to specify the date when the last meeting for the study was held. *This property does not apply to COI. |
| rb.use_first_meeting_date | When set to “Yes”, this property will display a First Meeting Date field in the Study Profile, allowing the review board to specify the date when the first meeting for the study was held. *This property does not apply to COI. |
| rb.use_genetic_testing | When set to “Yes”, this property displays a “Yes/No” radio button selection in the Study Profile, which allows the review board to indicate whether Genetic Testing is used on a study. |
| rb.use_ind_ide | When set to “Yes”, this property displays a “Yes/No” label in the Study Profile, allowing the review board to indicate if the study will use an IND/IDE. |
| rb.use_PHI_disclosed | This property displays a “Yes/No” radio button selection in the Study Profile. When this property is set to “Yes”, the review board has the ability to indicate whether the study PHI is disclosed or not. |
| rb.use_pi_initiated | This property 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 Principal Investigator-initiated or not. |
| rb.use_project_number | When set to “Yes”, this property displays the project number of a study. (Note that 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” in System Administration > System Configuration > Study Default Settings for this property to take effect) |
| rb.use_accrual_ceiling | This property displays the study’s accrual ceiling. |
| rb.use_accrual_target | This property displays the study’s accrual target. |
| rb.use_blinding_method | This property displays the study’s blinding method. |
| rb.use_study_classification | This property displays the study classification. |
| rb.use_study_coordinating_number | This property displays the study coordinating number. |
| rb.use_study_ctep_number | This property displays the study’s CTEP number. |
| rb.use_study_current_enrollment | This property displays the current subject enrollment in the study. |
| rb.use_study_enrollment | This property displays the number of subjects enrolled in a study. The number displayed here will populate with the actual number of subject records enrolled on a study if using Subject Management. *This property is not applicable unless using Subject Management. |
| rb.use_study_finance_role | This property displays the study finance role field. |
| rb.use_study_keywords | This property displays the study’s keywords. |
| rb.use_study_peds_category | This property displays the pediatrics category associated with the study. |
| rb.use_study_phase | This property displays the phase of the study. |
| rb.use_study_radiation_use | This property displays the radiation use field. |
| rb.use_study_research_type | This property displays the research type of the study. |
| rb.use_study_storage_code | This property displays the storage code of the study. |
| rb.use_therapeutic_area | This property displays the therapeutic area associated with the study. |
| rb.use_study_va_number | This property displays the study’s VA Number. |
Submission Review Properties
These properties affect the way COI matches are processed within the Conflict Matches queue.
| PROPERTY | DESCRIPTION |
|---|---|
| rb.allow_submission_doc_add | This property will allow the review board to attach a Consent form or other study documents to a submission from within the Submission Components tab. *This property does not apply to COI. When this property is set to “No,” the Attach Document button will not appear on the Submission Components tab page. |
| rb.allow_submission_doc_delete | This property will allow the review board to remove a document from a submission within the Submission Components tab. When this property is on, the user will be able to delete certain attachments by clicking the red X next to the item. *This property does not apply to COI. When the property is set to “No,” the review board will not be able to delete any attachments found in the Submission Components tab. |
| rb.auto_assign_analyst_on_response | When this property is set to “Yes,” the previously assigned Analyst who returns a submission for corrections will automatically be reassigned when a Return Response Submission is processed. Note: This property should be paired with a Return Response Action in the Workflow. Once this action is added to the Review Response Submission Form’s workflow, this property will become effective. *This property does not apply to COI. |
| rb.display_master_study_summary | This property controls the display of the Master Lay Summary field, found in the General Information tab of a submission. *This property does not apply to COI. 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 field, found in the General Information tab of a submission. *This property does not apply to COI. 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.use_agenda_state | This property determines if the Agenda State field will be displayed in 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. *This property does not apply to COI. If this property is set to “Yes,” the IRB Expiration Date will populate with a date upon selecting a Submission Approval date. If this property is set to “No,” the IRB Expiration date will not populate with a date until the Submission Approval Date is set, a Review Cycle is chosen, and the Calculate Date button is clicked. |
| rb.use_coord_view_all_comments | This property will allow the IRB analyst to share comments with all reviewers conducting a submission review. This property works together with the Submission Comments for All Reviewers data value, found within the forms designer. Using the two together will allow the Analyst to merge comments into the reviewer form so that assigned reviewers can access the comments while conducting their review. *This property does not apply to COI. |
| rb.use_expiration_calculation_restriction | This property will restrict a study expiration date from being set when approving a submission for Initial Reviews and Continuing Reviews. *This property does not apply to COI. If this property is set to “Yes,” setting Outcome information for a submission that is not an Initial Review or Continuing Review will disable the Review Cycle and IRB Expiration Date. 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_meeting_approval_date | Setting this property to “Yes” will enable the Meeting Approval Date field in the Outcome tab. *This property does not apply to COI. The Meeting Approval Date is an alternate approval date for a submission. Using the Meeting Approval Date will cause the IRB Expiration Date to recalculate, using the Meeting Approval Date as opposed to the Submission Approval Date. |
| rb.use_meeting_vote_summary | This property determines whether anonymous voting will be used in the documentation of 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 or On the meeting functionality. If this property is set to “Yes”, the Review Board will be able to conduct meetings within iRIS. If this property is set to “No”, the meeting functionality will be turned off If this property is turned off, it will also be necessary to edit and save the Define Role Access matrix, log out of iRIS, and log back in to make the changes effective in the system. Additionally, when the property is turned back on, the Define Role Access matrix will need to be revisited to make the necessary changes in order to access the options involving meetings in iRIS again. |
| rb.use_member_checklist | This property turns On or Off the member checklist functionality within 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,” the Review Board will be able to use the member checklist. 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 | This property turns On or Off the member comments in the Review Checklist and Comments tab. If this property is set to “No,” this feature will be turned off. If this property is set to “Yes,” the member comments will be available in the Review Checklist and Comments screen. |
| rb.use_outcome_letter | This property will turn on or off the ability to create and send Outcome Letters and Management Plans from within the system. If this property is set to “No,” this feature will be turned off. The Management Plan & Outcome Letter tab will remain visible in the processing screens, but the ability to create and send a letter will not be available. It is recommended that if this functionality is turned off, the corresponding tab in the Review Board Administration – Setup Role Access area also be turned off. If this property is set to “Yes”, the Outcome Letter feature will be available for use. |
| rb.use_past_meetings | This property will turn on or off the ability to add an item to a past meeting. Set this property to “Yes” to allow the addition of items to past meetings. Set the property to “No” to restrict this ability. |
| 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, a green icon will appear next to each question in the form. When clicked, this icon will allow the reviewer to add comments to a submission, which can then be merged into stipulations as needed in the Review Summary tab. *This property does not apply to COI. When this property is off, the comment icons will not appear in the submission forms. Note, this property does not enable the ability to comment within the Research Application. See property rb.use_review_comments_ro for this functionality. |
| rb.use_review_comments_ro | This property turns on or off the ability for reviewers to add comments when examining research applications. When a reviewer views an application and this property is off, a green icon will appear next to each question in the form. When clicked, this icon will allow the reviewer to add comments to the research application, which can then be merged into stipulations as needed in the Review Summary tab. *This property does not apply to COI. When this property is on, the comment icons will not appear in the application form. |
| rb.use_review_discussion | This property controls whether the Review Discussion tab appears in the Submission Processing screens. *This property does not apply to COI. |
rb.use_review_ recommendations | This property controls whether the Recommendations tab appears in the Submission Processing screens. *This property does not apply to COI. |
| rb.use_review_stipulations | This property controls whether the Stipulations tab appears in the Submission Processing screens. *This property does not apply to COI. |
| rb.use_review_summary | This property controls whether the Review Summary tab appears in the Submission Processing screens. *This property does not apply to COI. |
| rb.use_reviewer | When this property is turned on, a field will populate below the Review Process allowing for the addition of a reviewer. When this property is off, the Add Reviewer button will not populate in the Review Assignment page. Turning this property off will also disable functionality in the Review Checklist and Comments page as the Reviewer Checklist table will not be displayed. |
| rb.use_submission_by_committee | If the review board queue needs to be separated into committee submissions, use this property. Submissions will be assigned to the specified committee’s queue within the review board, rather than the review board as a whole. iMedRIS recommends not setting this property without discussion with iMedRIS personnel beforehand. *This property does not apply to COI. If this property is set to “Yes,” the review board will be split into committees. Each committee will have its own Submissions queue, which will not be able to access submissions to other committees unless the user associated to one committee is also associated to another committee. Additionally, when a user is in the Committee Submissions screen, the heading at the top of the page will indicate what committee he or she is in. Note: using this functionality will require a modification to the workflow. Once the workflow has been modified, the Submissions will be automatically routed to the specified committee. If this property is set to “No,” all board members will be associated with one review board and will work from one Submission queue. |
| rb.use_submission_letters | This property turns On or Off the Review Board’s Submission Received Notification Letter section in the Submission Processing screens. If this property is set to “Yes,” the Submission Received Notification tab will be turned on. If this property is set to “No,” the Submission Received Notification tab will be turned off. *This property does not apply to COI. |
| rb.use_submission_vote_summary | This property controls whether anonymous voting will be documented for Conflict Match items in board 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 for Conflict Match items. Instead, the name of each voting member present at the meeting will populate and the type of vote will need to be specified next to each name. |
| rb.useReviewRouting | This property controls the Internal Routing tab within the submission processing screens. When this property is set to “Yes,” the Internal Routing tab displays. Note: If this property is turned on, role access will need to be set in Review Board Administration > Setup Role Access. When this property is set to “No,” the Internal Routing tab will not display within the Submission Processing screens. |
| rb.useReviewRouting_user_role | This property controls whether or not to specify a user’s role when assigning a user to an Internal Routing process. When this property is set to “Yes,” roles will be available for assignment for Internal Routings. Note that the role list will need to be configured under Review Board Administration > List Maintenance Setup > Internal Routing User Roles. When set to “No,” internal routing roles will not be available for assignment. Note that this property is not applicable if the rb.useReviewRouting property is turned off. |
Reviewers
The reviewer properties control different elements of the Reviewer Assignments within the COI Review Board.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.copy_previous_reviewer_form | This property is used in conjunction with rb.use_previous_submission_reviewers. *This property does not apply to COI. If rb.use_previous_submission_reviewers is set to “Yes” and this property is set to “Yes,” when choosing to assign a previously assigned reviewer 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 a Reviewer accesses his or her new assignment, the Reviewer Checklist will be populated with the same answers that were applied in the previous Reviewer Checklist. If rb.copy_previous_reviewer_form is set to “No,” the system will still assign the previous reviewer, but previous data will not be copied over to the new checklist. |
| 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 when they open their review assignment task from the home screen. If this property is set to “No,” the reviewer will be directed into the reviewer checklist when they open their reviewer assignment from the home screen. |
| 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.number_days_to_notify_reviewers | This property’s value signifies the number of days prior to a meeting from which a reviewer notification is to be sent. Note that a value of -1 = ignore. This property can be set to any whole, non-negative number (excluding -1). |
| rb.restrict_KSP_from_reviewers | This property, when set to “Yes,” will restrict Key Study Personnel from appearing in the “Reviewers” dropdown list. When set to “No,” the members will be included in the list of Reviewers regardless of whether they are KSP on the same study. *This property does not apply to COI. |
| rb.restrict_reviewer_to_voting_member | When this property is set to “Yes,” the dropdown list of available reviewers will be restricted to voting members on the current committee. If this property is set to “No,” the non-voting members of the committee will also be included in the list of available reviewers. *This property does not apply to COI. |
| Rb.reviewers_form_completes_submission | When this property is set to “Yes,” upon a reviewer completing his or her review, the system will also complete the submission (assuming the Reviewer’s form has the Reviewer’s indication for a “Complete” data value). *This property does not apply to COI. |
| rb.use_designated_reviewer | Designated Review is an option that can be used within the Review Process in iRIS. Setting this property to “Yes” will enable the review process “Designated Reviewer,”, which will allow a submission to be assigned to a designated reviewer. *This property does not apply to COI. If this property is set to “No,” the Designated Reviewer option will not display in the review process list. |
| rb.use_previous_submission_reviewers | This property allows the ability to assign previously assigned reviewers to a submission. *This property does not apply to COI. When this property is set to “Yes” and a submission comes back into the review board queue, an Add Previous Reviewers button will populate in the Pre-Review Screening tab > Assign Reviewers table. When clicked, the system will reassign the reviewers who were assigned in 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 the use of reviewer signoff pages, similar to the signoffs for submission forms. When this property is set to “Yes,” instead of a Reviewer Indication of Completion value in the 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 to the signoff sheet, 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 allow the reviewers to indicate their review completion within the form. |
| rb.use_shortened_reviewer_comments | This property will display a shortened reviewer comment. Rank and Item Number will be omitted when comments are merged from the Review Summary into the Submission Discussion or the Outcome Letter. *This property does not apply to COI. When this property is set to “Yes,” the shortened merged comments appear without the Rank and Item Number. When this property is set to “No”, the merged comments will appear with their regular content, with Rank and Item Number included.
|
| rb.use_study_assigned_reviewers | This property will include study role-assigned reviewers, who have been set up in the workflow for signoff, to the list of Reviewers from which to choose from. When this property is set to “No,” the study role-assigned reviewers will not be included in the dropdown list located on the Pre-Review Screening tab for reviewer selection. *This property does not apply to COI. |
| rb.use_view_of_reviewers_for_members | This property will hide reviewer checklists from members that are not assigned to review a conflict match. If this property is set to “Yes,” all members of the board will be able to view each other’s checklists, regardless of whether they have been assigned to review the same conflict match. If this property is set to “No,” members not assigned as reviewers for a particular conflict match will be unable to see reviewer checklists from that conflict match. |
| rb.x_calendar_days | When a submission is placed on an agenda within the Pre-Review Screening process, this property will automatically finalize the agenda and send out a notification to members “x” amount of days before the meeting is scheduled to take place, regardless of whether or not the agenda is finalized by the coordinator yet. |
Meeting Settings
Meeting Settings properties relate to meetings for the review board. These properties control the display of member attendance on the meeting page and the quantity of meetings iRIS should generate in a Meeting Schedule.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.generate_meeting_in_days | This property indicates the number of meetings the system will generate when you create a recurring meeting schedule using the Meeting Schedule within Meeting Manager. The default setting for this property is 365, meaning iRIS will generate a year’s worth of meetings based on the criteria entered for the recurring meeting. Should the system need to generate more or less, change the number of days appropriately. |
| rb.use_expedited_report | If the review board would like to keep expedited submissions in a separate report, as a meeting page attachment, this property can enable this functionality. *This does not apply to COI If this property is set to “Yes”, much like an agenda or minutes template, an Expedite Report can be created in Review Board Administration > List Configuration and Maintenance. Using the Meeting Manager, an Expedited Report can be generated in the same way as that of an agenda document. When the Expedite Report is published, it will be available to view on the Meeting Agenda page. When this property is set to “No,” the Expedite Report information will not be available and Expedited Submissions can be pulled into the main body of the Agenda and Minutes templates. |
| rb.use_member_absent | This property controls the display of voting member’s attendance on the Meeting Agenda page. When this property is set to “Yes,” voting members not marked as present at the meeting will auto-populate in a “Voting Members Absent” group within the Meeting Attendance area of the Meeting Agenda page. 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 Agenda. |
| rb.use_non_member_absent | This property controls the display of non-voting member’s attendance on the Meeting Agenda page. When this property is set to “Yes,” any non-voting member not marked as present at the meeting will auto-populate in a “Non-Voting Members Absent” group within the Meeting Attendance area of the Meeting Agenda. If this property is set to “No,” any non-voting member not marked as present at the meeting will simply not show up on the Meeting Agenda. |
| rb.use_staff_absent | This property controls the display of staff’s attendance 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 within the Meeting Attendance area of the Meeting Agenda. If this property is set to “No,” any staff not marked as present at the meeting will simply not show up on the Meeting Agenda. |
Security
Security properties allow the system administrator to define whether or not the review board should be able to search for studies not associated to the review board, and if Key Study Personnel should be allowed to access submissions when they have an assigned role on the board.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.restrict_access_from_KSP | This property restricts the KSP of a study from opening a study on the IRB side. This applies if the user has a role on the review board as well. If the property is set to “No”, KSP access is not restricted. If the property is set to “Yes”, KSP’s access is restricted and an error message will appear when the KSP attempts to open the study from the review board (see screenshot below). *This does not apply to COI. |
| rb.restrict_find_to_rb | This property restricts access to studies that do not belong to the Review Board. *This does not apply to COI. If this property is set to “Yes,” only studies that have an association to the review board will populate in the results when using Find a Study. If this property is set to “No,” all studies in the database can be searchable and accessible by the review board when using Find a Study. |
Recommendations and Stipulations
These properties are related to management strategies and how the system will handle them.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.update_recommendation_by_all | This property allows members to update recommendations. *This property does not apply to COI. If the property is set to “No,” the reviewers cannot update recommendations. If this property is set to “Yes,” a button will appear to allow the reviewers the ability to update recommendations. *Note that this option will not apply if the rb.use_review_recommendations property is off. |
| rb.update_stipulation_by_all | This property allows members to update stipulations. If this property is set to “No”, the members cannot update stipulations. *This property does not apply to COI. If this property is set to “Yes,” a button will appear to allow the reviewers the ability to update stipulations. *Note that this option will not apply if property 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”. *This property does not apply to COI. 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 of the Stipulations that Must be Addressed type, Send Bundle Email will not populate on the page. If rb.use_bundle_to_external_source is set to “Yes” and rb.use_bundle_stipulations is set to “No,” Send Bundle Email will always be available on the Submission Complete tab, regardless of what kind of Stipulations have been created for the submission. |
| rb.use_stipulation_category | This property will enable the use of stipulation categories for Management Strategies. When set to “Yes,” stipulation categories will need to be defined in Review Board Administration > List Maintenance Setup tab > Strategy Category. Once categories have been created, they will be available for selection when creating Management Strategies on a conflict match. If this property is set to “No,” the ability to associate a stipulation category to a Management Strategy will not be available. |
| rb.use_stipulation_control_response | If any Stipulations are added to a submission, this property will return the study to the originator by default. *This property does not apply to COI. If this property is set to “Yes,” a stipulation added to a submission will result in the “Additional Information Required” field within the Outcome tab of the submission to always say “Yes,” regardless of the submission outcome selected. Additionally, if there are no stipulations added to the submission, the Additional Information Required field will always say “No” regardless of the outcome selected. When this property is set to “No,” the Additional Information Required field will say “Yes” or “No” depending on the Outcome selected. |
| rb.use_stipulation_tracking | Stipulation Tracking is a tool within Review Board Assistant which allows the tracking of outstanding stipulations as well as the ability to view previously closed stipulations. *This property does not apply to COI. If this property is set to “Yes,” a new link will appear within the Review Board Assistant called Stipulation Tracking. The system administrator may need to enable this link within Role Access when initially turning on this property. If this property is set to “No,” the Stipulation Tracking link will 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_continue_review_due | When this property is set to “Yes,” then the Continuing Review Due field will display on the Outcome tab of the submission along with the Study Summary/Profile Screen. *This property does not apply to COI.
|
| rb.use_expiration_date | When this property is set to “Yes,” then the Expiration Date field will display in the Outcome tab of the submission along with the Study Summary/Profile Screen. *This property does not apply to COI. 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 on the Outcome tab of the submission along with the Study Summary/Profile Screen. The date will populate with a read-only version of the Last Continuing Review form that was approved. *This property does not apply to COI. When set to “No,” this field will not display. |
Letter
Letter properties are in place to help control the 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. *This property does not apply to COI. |
| rb.use_default_recipient_not_selected | This property will determine whether the recipient list for outcome letters should automatically be selected by default. If this property is set to “Yes”, the recipients’ checkboxes will not be automatically selected. *This property does not apply to COI. |
COI Process Match Object
The COI Process Match Object group provides the ability to designate whether to utilize the Management Plan section when processing Matched Objects.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_coi_management_plan | If this property is set to “Yes,” the Management Plan Document feature will be made available in the Management Plan & Outcome Letter tab of the Conflict Match Processing screens. If this property is set to “No,” the Management Plan letter will need to be generated as part of the Response letter group. |
Notification
Notification properties configure the type of tasks analysts should receive for conflict matches.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_internal_routing_complete_queue | When this property is set to “Yes,” the Assigned Analyst for a conflict match will get a task notification, which will appear on his or her home screen, specifying that an Internal Routing has been completed. If this property is set to “No,” Internal Submission Routing Complete notifications will not appear on the Analyst’s home screen. |
| rb.use_outcome_signoff_complete_queue | When this property is set to “Yes,” the Assigned Analyst for a conflict match will get a task notification, which will appear in his or her home screen, specifying that the Outcome Letter Signoff has been completed. If this property is set to “No,” Outcome Letter Signoff Complete notifications will not appear in the Analyst’s home screen. |
| rb.use_reviewers_complete_queue | When this property is set to “Yes,” the Assigned Analyst for a conflict match will get a task notification, which will appear in his or her home screen, specifying that all the Reviewers have completed their review. If this property is set to “No,” the Submission Reviewers Complete task notification will not appear in the Analyst’s home screen. |
Submission Prereview
Properties in this group relate to the Review Process set in Review Assignment for a conflict match. Depending on the review board type, certain review processes may be turned on or off.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_review_process_agenda | If this property is set to “Yes,” the option to assign a conflict match to a Review Committee Agenda in the Review Assignment tab of a conflict match will become available. If this is set to “No,” the option to assign a conflict match to a Review Committee Agenda in the Review Assignment tab will not be available. |
| rb.use_review_process_emergency_use | If this property is set to “Yes,” the option to assign the submission to Emergency Use in the Pre-Review Screening tab will become available. *This property does not apply to COI. If this property is set to “No,” the option to assign the submission to Emergency Use in the Pre-Review Screening tab will not be available. |
| rb.use_review_process_exempt | If this property is set to “Yes,” the option to assign the submission as Exempt in the Pre-Review Screening tab will become available. *This property does not apply to COI. If this is set to “No,” the option to assign the submission as Exempt in the Pre-Review Screening tab will not be available. |
| rb.use_review_process_expedited | If this property is set to “Yes,” the option to assign a conflict match as an Expedited Review in the Review Assignment tab of a conflict match will become available. If this is set to “No,” the option to assign a conflict match as an Expedited Review in the Review Assignment tab of a conflict match will not be available. |
| rb.use_review_process_forward | If this property is set to “Yes,” the option to forward the submission to another board or committee in the Pre-Review Screening tab will become available. *This property does not apply to COI. If this is set to “No,” the option to forward the submission to another board or committee in the Pre-Review Screening tab will not be available. |
| rb.use_review_process_facilitated | If this property is set to “Yes,” the option to assign the submission to Facilitated Review in the Pre-Review Screening tab will become available. *This property does not apply to COI. If this is set to “No,” the option to assign the submission to Facilitated Review in the Pre-Review Screening tab will not be available. |
Submissions
Use the properties in the Submissions group to control the display of Study Classification and Risk Assigned in the Submissions queue. *These properties do not apply to COI.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_risk_assigned_displayed | This property relates to the Risk Assigned column, which is displayed in the review board Submissions queue. *This property is not related to COI. If set to “Yes,” this property will display a Risk Assigned column in both the Not-Assigned and Assigned tabs of the Submissions queue. If set to “No,” the Risk Assigned column will not display. |
| rb.use_study_classification_displayed | This property relates to the Study Classification column, which is displayed in the review board Submissions queue. *This property is not related to COI. If set to “Yes,” this property will display a Study Classification column in both the Not-Assigned and Assigned tabs of the study Submissions queue. If set to “No,” the Study Classification column will not display. |
Internal Routing
Internal Routing specifies whether or not to capture an electronic signature for an Internal Routing task.
| PROPERTIES | DESCRIPTION |
|---|---|
| rb.use_signature_on_internal_routing | This property controls whether or not to capture a user’s electronic signature when completing an Internal Routing task. If this property is set to “Yes,” an electronic signature will be required when processing an Internal Routing task. When this property is set to “No,” the User ID and Password fields will not populate on the page. |
© iMedRIS Data Corporation