In the context of the iRIS™ system, a business associate is an institution or business which interacts with the institution where iRIS™ is in use.
Business associate entities can be added as a study sponsor, vendor or subrecipient, or as a third party in a conflict of interest.
Navigation in iRIS™
iRIS™ includes two standard navigation tools on all pages nested one or more levels beneath the primary Workspace page of the module currently in use (e.g., Study Assistant, Conflict of Interest Assistant, Animal Resource Center, etc.): a Path directory tree, and Back buttons.
Path Directory Tree
The Path item at the upper left of iRIS™ pages provides a hyperlinked menu directory tree, allowing the user to quickly navigate back through the path they followed to get to their current location. Path appears on all pages nested at least one level beneath the main workspace
In the example shown the user is viewing the Broadcast Notice Add a new notice page. This page is nested three levels beneath the main workspace page, as indicated by the three links available in the Path directory tree: Home, board admin and broadcast notice.
Click on broadcast notice in the Path to navigate up one level in the directory tree, to the main Broadcast Notice page. There are now two levels in the Path directory tree: board admin and Home.
Click on board admin in the Path to navigate up one level in the directory tree, to the Board Administration page. There is now one level in the Path: Home.
Click on Home in the Path to navigate up one level in the directory tree, to the main Workspace page. No Path item is displayed here because the user is now at the top-most level of the directory tree.
Back Button
The second navigation tool is the Back button, which appears on all pages nested at least one level beneath the main workspace. The Back button takes the user to the same location as the last link shown in the Path.
In the example shown above, both the Back button and the broadcast notice link in the Path return the user to the Broadcast Notice page:
Clicking the Back button on the Broadcast Notice page returns the user to the Board Administration page, as indicated by the last link in the Path directory tree shown in the screenshot above.
Note that where the Back button appears on a page with editable fields or document upload controls, clicking the button before saving changes returns the user to the same location as the last link shown in the Path without saving changes.
System Setup of Business Associate List
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page opens.
A search form is provided at the top of the page to enable quick location of a specific record in the list. It can be used to search by Name, Associate Group, or a combination of both.
Buttons at the upper right provide the ability to Download Associate Configuration Template, Upload Associate Configuration, Merge Associate Records or Add a New Associate.
Add a New Business Associate
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page opens.
Click the Add a New Associate button.
An add panel opens, with data entry fields for the new business associate entity record. Enter applicable data in the text fields provided.
Associate Abrv — abbreviation for the business associate entity (e.g., APharm for Abbott Pharmaceuticals), if any
Associate Name — business associate entity name
Status — internal status of the record; “Deleted” is the default value, status changes to “Active” when the record is saved
Associate Group — designated group to which the business associate is assigned; depending on the selection here, additional data entry fields may populate in the page for addition of optional details
Note: Associate Group is a configurable list.
Associate Type / Sponsor Type — designated Associate Type / Sponsor Type to which the business associate is assigned; note that the label for this field dynamically updates depending on the Associate Group(s) selected
Note: Associate Type and Sponsor Type are configurable lists.
Street 1 & 2, City, County/Parish, State, Province, Country, Zip/Postal Code —address details for the business associate entity
Click the Save Changes button in the add panel to add the new business associate record to the master list.
Download / Upload Business Associates
The Download Associate Configuration Template and Upload Associate Configuration buttons are used for adding multiple business associate entity records simultaneously, as a batch. Note that this method cannot fully populate each business associate entity record, as the template used for batch processing includes only three data fields.
Click the Download Associate Configuration Template button to download an Excel spreadsheet template containing a column for each of the three required business associate record data fields. A download dialog popup window appears.
Click the Save button and save the template to a known location on the computer or network. Open the downloaded spreadsheet template and populate it for all business associate records to be uploaded.
Content requirements are provided at the top of each column. When changes are complete, save and close the spreadsheet template.
Back on the System Setup of Business Associate List page, click the Upload Associate Configuration button to upload the completed spreadsheet template. An upload dialog popup window appears.
Click the Choose File button and navigate to the location of the spreadsheet template, then click the Save Selected file button in the popup window to complete the upload.
The business associate records from the spreadsheet template are added to the master list.
Merge Business Associate Records
The Merge Associate Records function is used to eliminate duplicate business associate entity records from iRIS™.
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page opens. Click the Merge Associate Records button to begin.
A list of existing business associate entity records is displayed, with select checkboxes in a column at left. To merge records, two or more checkboxes must be selected.
In the example shown above two business associate entity records have been added for the American Heart Association, but only the second record is valid. The checkboxes to the left of both records are selected.
Click the Merge Selected Records button to continue to the next step. A panel containing all the records selected to merge appears.
Select the record that will be kept by clicking its radio button in the far-left column.
Continuing with the example case, the second radio button is clicked to indicate the second record is the valid one and should be kept. Only one record can be selected in the panel, and all records whose radio buttons are left blank will be deleted.
Click the Merge button to complete the merge. A confirmation dialog popup window appears.
Click the Cancel button to cancel the merge.
Click the OK button to confirm the merge.
Note: Where a record that is deleted via a merge operation has previously been assigned to one or more studies, the merged (saved) record is assigned in place of the deleted record.
Edit Business Associate
After a business associate record is created it can be edited, and numerous other data items that were not available at the time the associate record was created can be added to the record.
To edit a business associate entity record, navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page opens. Click the icon in the Edit column for the applicable record.
A panel opens, providing editable data fields for the business associate entity record.
Three additional sections that are not available when adding a new record are now accessible in the edit panel: Business Associate Contacts, Business Associate Risk Management and Business Associate F&A Rate History.
Business Associate Contacts
Recall that in the context of the iRIS™ system, a business associate is an institution or other entity involved in research being tracked within iRIS™. A business associate contact is a person who is designated as a point of contact for the entity.
Institutions can maintain a list of business associates and contacts in the iRIS™ system via IACUC Assistant > Review Board Administration > List Maintenance Setup tab > Business Associate List link.
Add Business Associate Contact
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate entity record by clicking the icon in the Edit column for the corresponding record.
The System Setup of Business Associate List page opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
Scroll down to the Business Associate Contacts section and click the Add a New Business Associate Contact button.
A panel opens with data entry fields for creation of a contact profile.
Enter a Last Name and complete other fields as desired, then click the Save Changes button to save the contact record and close the page.
The new contact is added to the Business Associate Contacts section.
Edit Business Associate Contact
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate entity record by clicking the icon in the Edit column for the corresponding record.
The System Setup of Business Associate List page opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
Click the icon in the Edit column for the applicable contact in the Business Associate Contacts section of the page.
The same profile panel as shown for creating a new business associate contact opens, containing all profile information for the contact.
Edit data entry fields as desired, then click the Save Changes button to save changes and return to the main business associate (institution or site) record.
Delete Business Associate Contact
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate entity record by clicking the icon in the Edit column for the corresponding record.
The System Setup of Business Associate List page opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
Scroll down to the Business Associate Contacts section of the page and click the icon in the Delete column for the applicable contact.
A confirmation popup window appears.
Click the CONFIRM button to save changes and close the page.
Click the CANCEL button to close the page without deleting the contact record.
Business Associate Risk Assessment
Most business associate entities have A-133 risk assessment documents on file. These documents demonstrate the entity has conducted an audit to identify areas of risk in conducting research and has taken specific actions or put specific management plans in place to address any identified risk.
Add Business Associate Risk Assessment
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate entity record by clicking the icon in the Edit column for the corresponding record.
A panel with editable business associate fields opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
Scroll down to the Business Associate Risk Assessment section. This is where an A133 risk assessment can be designated for the business associate entity, and any supporting documents can be attached.
To add a risk mitigation history record, click the Add A133 History button.
An add panel opens.
Enter a Year for the entry and complete the rest of the form as desired.
Risk Assessment — risk assessment title or type
Notes — summary information or comments about the risk assessment
Click the Cancel And Return button to return to close the add panel without saving changes.
Click the Save Changes button to save the new record and close the panel. The Business Associate add A133 Audit Document panel opens for attachment of supporting documentation.
Enter the document Title, Version Number and Description, then click the Upload button.
An Upload Document popup window appears.
Click the Cancel button to close the popup without uploading the document.
Click the Browse button to navigate to the desired document file. When the location of the desired attachment appears in the Document Location field, click the Save selected file button to complete the upload.
The document is uploaded and attached to the history record.
Click the icon in the View the document panel to view the attached document. Click the Save Changes button to save the history record with attachment.
The Business Associate add A133 Audit Document panel closes and the audit document is added for the applicable business associate entity.
Risk Assessment Document List
The Risk Assessment Document List is where all supporting documents for a given Risk Assessment record are shown. Supporting documents can be edited, added or deleted.
Edit Risk Assessment Document
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate entity record by clicking the icon in the Edit column for the corresponding record.
A panel with editable business associate fields opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
Scroll down to the Business Associate Risk Assessment section and click the plus sign for the applicable record to open its Document List.
The Document List is expanded, with options to view, add, edit or delete attachments.
Click the document icon in the File column to download a copy of the attachment.
Click the icon in the Edit column to the left of an attachment to view or edit attachment details.
The Business Associate add A133 Audit Document panel for the attachment opens, with editable fields.
Title, Version Number and Description fields can be edited in this panel and the Upload… button is enabled. Any file uploaded here will replace any existing file already attached to the risk assessment record.
Click the Save Changes button to save changes and close the panel.
Add Risk Assessment Document
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate entity record by clicking the icon in the Edit column for the corresponding record.
A panel with editable business associate fields opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
Scroll down to the Business Associate Risk Assessment section and click the plus sign for the applicable record to open its Document List.
The Document List is expanded, with options to view, add, edit or delete attachments.
Click the Add Document button. The Business Associate add A133 Audit Document panel opens for attachment of supporting documentation. Enter the document Title, Version Number and Description, then click the Upload button.
An Upload Document popup window appears.
Click the Cancel button to close the popup without uploading a document.
Click the Browse button to navigate to the desired document file.
When the location of the desired attachment appears in the Document Location field, click the Save selected file button to complete the upload. The document is uploaded and attached to the risk assessment record.
Click the icon in the View the document panel to view the attached document. Click the Save Changes button to save the history record with attachment. The document is added to the applicable Document List.
Click the icon in the File column to view the attached document.
Delete Risk Assessment Document
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate entity record by clicking the icon in the Edit column for the corresponding record.
A panel with editable business associate fields opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
Scroll down to the Business Associate Risk Assessment section and click the plus sign for the applicable record to open its Document List section. Select the checkbox for the document to be deleted and click the Delete Selected Document button.
A confirmation popup displays.
Click the OK button to confirm deletion and return to the System Setup of Business Associate List page.
Click the CANCEL button to return to the System Setup of Business Associate List page without deleting the document.
Edit Business Associate Risk Assessment
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
Click the icon for the applicable business associate in the Edit column.
The System Setup of Business Associate List page is opened.
Click the icon in the Edit column for the applicable record in the Business Associate Risk Assessment section.
The record is opened in a panel with editable fields.
Click the Cancel and Return button to close the panel without saving changes.
Make desired edits in the fields and click the Save Changes button to save changes to the record. The Business Associate add A133 Audit Document panel opens for attachment of supporting documentation.
Any document added here will be appended to the risk assessment record, it will not replace any documents previously uploaded for the same record.
Enter the document Title, Version Number and Description, then click the Upload button.
An Upload Document popup window appears.
Click the Cancel button to close the popup without uploading the document.
Click the Browse button to navigate to the desired document file. When the location of the desired attachment appears in the Document Location field, click the Save selected file button to complete the upload.
The document is uploaded and attached to the history record. Click the icon in the View the document panel to view the attached document. Click the Save Changes button to save the history record with attachment.
The Business Associate add A133 Audit Document panel closes and the audit document is added for the applicable business associate contact. Click the document icon in the File column to download a copy of the attachment.
Delete Business Associate Risk Assessment
To delete a business associate risk assessment record, navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate record by clicking the icon in the Edit column for the corresponding record.
A panel with editable business associate fields opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
The second panel in the lower section of the System Setup of Business Associate List page is Business Associate Risk Assessment. Click the icon in the Delete column for the corresponding record.
A confirmation popup window displays.
Click the CANCEL button to cancel deletion.
Click the CONFIRM button to confirm deletion.
Note that deleting a business associate risk assessment record also deletes any attachments saved to the record.
Business Associate F&A Rate History
Business associate entities involved in research activities typically have a standard rate for charging fees to reimburse the entity’s F&A (Facilities and Administration) expenses.
In the iRIS™ system these fees can be tracked for each business associate entity.
Add Business Associate F&A Rate History
To add F&A rate history to a business associate record, navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate record by clicking the icon in the Edit column for the corresponding record.
A panel with editable business associate fields opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
The bottom panel in the lower section of the System Setup of Business Associate List page is Business Associate F&A Rate History.
Click the Add F&A History button to begin.
A panel opens for entry of F&A information.
Enter the Year for the applicable F&A rate.
Use the Notes field to enter F&A rate details for that year for the currently active business associate.
Click the Cancel And Return button to close the panel without saving changes.
Click the Save Changes button to save changes and close the panel. The Business Associate add Document panel opens for upload of a supporting document.
Enter a Title, Version Number and Description for the document to be uploaded, then click the Upload… button.
An Upload Document popup window appears.
Click the Cancel button to close the popup without uploading a document.
To upload a document, click the Browse button to navigate to the desired document file. When the location of the desired attachment appears in the Document Location field, click the Save selected file button to complete the upload.
The document is uploaded and attached to the F&A record.
Click the icon in the View the document panel to view the attached document. Click the Save Changes button to save the F&A record with attachment.
The Business Associate add Document page closes and the F&A rate history record is added to the business associate record.
Click the plus sign icon for the record to expand its associated Document List section.
F&A Rate History Document List
The F&A Rate History Document List is where all supporting documents for a given F&A Rate History record are shown. Supporting documents can be edited, added or deleted.
Edit F&A Rate History Document
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate record by clicking the icon in the Edit column for the corresponding record.
A panel with editable business associate fields opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
The bottom panel in the lower section of the System Setup of Business Associate List page is Business Associate F&A Rate History.
Click the plus sign to the left of a history entry to view details of documents attached to the history record.
The Document List area is expanded, with options to view, add, edit or delete attachments.
Click the document icon in the File column to download a copy of the attachment.
Click the icon in the Edit column to the left of an attachment to view or edit attachment details.
The Business Associate add Document panel for the attachment opens, with editable fields.
Title, Version Number and Description fields can be edited in this panel and the Upload… button is enabled. Any file uploaded here will replace any existing file already attached to the selected document record.
Click the Save Changes button to save changes and close the panel.
Add F&A Rate History Document
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate record by clicking the icon in the Edit column for the corresponding record.
A panel with editable business associate fields opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
The bottom panel in the lower section of the System Setup of Business Associate List page is Business Associate F&A Rate History.
Click the plus sign to the left of a history entry to view details of documents attached to the history record.
The Document List area is expanded, with options to view, add, edit or delete attachments.
Click the Add Document button. The Business Associate add Document panel opens for upload of a supporting document.
Enter a Title, Version Number and Description for the document to be uploaded, then click the Upload… button.
An Upload Document popup window appears. Click the Browse button to navigate to the desired document file. Any file uploaded here will be added to the F&A history. Any previously uploaded document for the selected F&A Rate History record remains in place and is not replaced by this upload.
When the location of the desired attachment appears in the Document Location field, click the Save selected file button to complete the upload. Click the Cancel button to close the popup without uploading the document.
The document is uploaded and attached to the F&A record.
Click the icon in the View the document panel to view the attached document. Click the Save Changes button to close the add panel and save the document to the F&A Rate History record. As shown below, the new document is added to the Document List.
Delete F&A Rate History Document
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
The System Setup of Business Associate List page is opened.
Open the applicable business associate record by clicking the icon in the Edit column for the corresponding record.
A panel with editable business associate fields opens, with sections for Business Associate Contacts, Business Associate Risk Assessment and Business Associate F&A Rate History.
The bottom panel in the lower section of the System Setup of Business Associate List page is Business Associate F&A Rate History.
Click the plus sign to the left of a history entry to view details of documents attached to the history record.
The Document List area is expanded, with options to view, add, edit or delete attachments.
Select the checkbox(es) for the document(s) to be deleted and click the Delete Selected Document(s) button.
A confirmation popup displays.
Click the CANCEL button to return to the System Setup of Business Associate List page without deleting the document.
Click the OK button to confirm deletion and return to the System Setup of Business Associate List page. The document is deleted from the Document List section.
Edit Business Associate F&A Rate History
Navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
Click the icon for the applicable business associate in the Edit column.
The System Setup of Business Associate List page is opened.
Click the icon in the Edit column for the applicable record in the Business Associate F&A Rate History section.
The record is opened in a panel with editable fields. Make desired edits in the fields.
Click the Cancel and Return button to close the panel without saving changes.
Click the Save Changes button to save changes and close the panel. The Business Associate add Document panel opens for upload of a supporting document.
Enter a Title, Version Number and Description for the document to be uploaded, then click the Upload… button.
An Upload Document popup window appears.
Click the Cancel button to close the popup without uploading the document.
Click the Browse button to navigate to the desired document file. Any file uploaded here will be added to the F&A history. Any previously uploaded document for the selected F&A Rate History record remains in place and is not replaced by this upload.
When the location of the desired attachment appears in the Document Location field, click the Save selected file button to complete the upload.
The document is uploaded and attached to the F&A record.
Click the icon in the View the document panel to view the attached document. Click the Save Changes button to close the page and save changes to the Business Associate F&A Rate History record.
Delete Business Associate F&A Rate History
To delete a business associate F&A history record, navigate to IACUC Assistant > Review Board Administration > List Maintenance Setup tab and click the Business Associate List link.
Click the icon for the applicable business associate in the Edit column.
The System Setup of Business Associate List page is opened.
Click the icon in the Delete column for the applicable record in the Business Associate F&A Rate History section.
A confirmation popup window displays.
Click the CANCEL button to cancel deletion.
Click the CONFIRM button to confirm deletion.
Note that deleting an F&A history record also deletes any attachments saved to the record.