This manual will guide you through the fourth and fifth tabs in List Configuration and Maintenance within System Administration.

List Configuration and Maintenance houses many of the system wide list configurations such as master lists, system setup tools, user setups, notifications, as well as maintenance tools such as clean-up and system audits.

Upon entering the List Configuration and Maintenance area, you will have access to the configuration options, displayed as a tabbed list with 5 main categories, System Setup, Site List Setup, System Notifications, Clean-up and Audits. Each category is viewed by selecting the tab at the top of the screen. The following sections of this manual review functionality in the first tab Clean-up, and later, the Audits tab.

Clean-up

The Clean-up tab allows a System Administrator the ability to clean-up duplicate records and add/edit information for studies, projects, subjects and users.

Study Clean-up

This area allows a System Administration the ability to clean-up study related issues. That will allow studies to be deleted or copied, specific users to be added or removed from study records, and review board numbers can be changed.

Typically, these types of changes are made by submitting proper submission forms to a study review board of record. However, if there is a need to administratively add, delete or copy certain items, this area can be used.

Copy Study

From this area you will have the ability to manually copy a study to create a new copy of the study that will be set in a DRAFT status.

After selecting the Copy Study link filter selections will populate which allow you to search for a Study you wish to Copy.

Select a Department – This field requires the selection of a department that is associated to the applicable study.

Please enter the Study to be Copied – Here the study info can either be entered or by selecting Find Study will populate a pop-up window with advanced search options.

After a selection has been made, selecting Copy Selected Study will create a DRAFT copy of the study, which can be found using Find a Study in Study Assistant, or within the KSP’s My Studies area.

Delete Study

From this area you will have the ability to manually set a study as deleted in the system. Be Cautious when deleting a study as there are no restrictions from deleting any study in any status in this area. When you delete a study, you delete all corresponding records with that study, including user access to that study, documents uploaded to that study and submissions that have been made from that study.

After selecting the Delete Study link, filter selections will populate which allow you to search for a Study that needs to be deleted.

Select a Department – This field requires the selection of a department that is associated to the applicable study. Select the study to be deleted – Here the Study info can either be entered or selecting Find Study will populate a popup window with advanced search options.

After a selection has been made, selecting the Delete Selected Study button will set the study as deleted within the system.

Add KSP To Studies

From this area you will have the ability to manually Add KSP (Key Study Personal) to a study.

After selecting the Add KSP To Studies link, filter selections will populate which allow you to search for the user you wish to add.

Selecting the Find button will bring you to the Directory to browse for the correct user. After the user has been selected the system populates additional options.

Select the Department associated to the Studies – This field requires the selection of a department that is associated to the applicable study, in order to retrieve the available studies for this action.

Select the role – Here, the Study Role you wish to assign to the KSP that is being added to the study can be selected. Note that you cannot add a user as a Principal Investigator using this tool, only Research Support Staff can be added with this tool.

After the selections have been made, selecting the Get Available Studies will populate a list of studies that match the listed criteria.

Select the applicable study, and User to Selected Studies.

Review Board Study Access

From this area you will have the ability to manually add access for specific existing review boards to a particular study.

This will cause any submissions that are sent on this study to send to the added review board, dependent upon the workflow setup. Also, reports run from this review board would include the study and study information that is accessible to the review board.

After selecting the Review Board Study Access link, filter selections will populate which allow you to search for the study you wish to add review board access to. Selecting the arrow button will populate an advanced search popup window.

After a study has been selected the system will direct you to a list of existing Review Boards, select the review board(s) that you wish to provide access to a particular study, and save.

Change Study Number

From this area you will have the ability to manually change the Project Number for existing studies within iRIS.

This area applies only to Project Numbers. You will not be able to change any other type of number (IRB, IBC, IACUC, etc.) from this area.

After selecting the Change Study Number link, filter selections will populate which allow you to search for the study you wish to make the adjustments to. Selecting the arrow button will populate an advanced search popup window.

Select a Department – This field requires the selection of a department that is associated to the applicable study, in order to retrieve the available studies for this action.

Please enter the Study to be changed – Select the applicable study. The Find a Study button here will populate a popup window with advanced search options.

Once a study has been selected, the Old Project Number will display with a field to enter the New Project Number.

Be sure to Save Changes when you have finished editing.

Remove Study Access

From this area you will have the ability to manually Remove KSP (Key Study Personal) from a study.

After selecting the Remove Study Access link, filter selections will populate which allow you to search for the user you wish to remove.

Selecting the Select a User to Remove KSP Access button will bring you to the Directory to browse for the correct user. After the user has been selected the system populates with all the Studies and Roles applicable to that users account.

After the selections have been made, selecting Remove Access to the selected User will remove that user(s) from the particular Role(s) on for that Study.

Project Clean-up

Copy Project

From this area you will have the ability to manually copy a project to a new copy of the project that will be set in a DRAFT status.

After selecting the Copy Project link filter selections will populate which allow you to search for a project you wish to Copy.

Select a Department – This field requires the selection of a department that is associated to the applicable project.

Please enter the Study to be Copied – Here the project info can either be entered or selecting the Find button will populate a popup window with advanced search options.

After a selection has been made, selecting Copy Selected project will create a DRAFT copy of the project, which can be found using Find a Project in Project Assistant, or within the KSP’s My Projects area.

Delete Project

From this area you will have the ability to manually set a project as deleted in the system. Be Cautious when deleting a project as there are no restrictions from deleting any projects in any status in this area. When you delete a project, you delete all corresponding records with that project, including user access to that project, documents uploaded to that project and submissions that have been made from that project.

After selecting the Delete Project link, filter selections will populate which allow you to search for a project that needs to be deleted.

Select a Department – This field requires the selection of a department that is associated to the applicable project.

Select the project to be deleted – Here the project info can either be entered or selecting Find Project will populate a pop-up window with advanced search options

After a selection has been made, selecting the Delete Selected Project button will set the project as deleted within the system.

Add KSP To Projects

From this area you will have the ability to manually Add KSP (Key Study Personal) to a project.

After selecting the Add KSP To Projects link, filter selections will populate which allow you to search for the user you wish to add.

Selecting the Find button will bring you to the Directory to browse for the correct user. After the user has been selected the system populates additional options.

Select the Department associated to the Projects – This field requires the selection of a department that is associated to the applicable project, in order to retrieve the available projects for this action.

Select the role – Here, the Project Role you wish to assign to the KSP that is being added to the project can be selected. Note that you cannot add a user as a Principal Investigator using this tool, only Research Support Staff can be added with this tool.

After the selections have been made, selecting the Get Available Projects will populate a list of Projects that match the listed criteria.

Select the applicable study, and User to Selected Project.

Subject Clean-up

This tool allows a System Administration the ability to clean-up subject related issues, it contains tools, allowing subjects to be deleted, you can transfer subject tasks to another study user and for locked subjects, you can administratively unlock their account for editing.

Delete Subject

Subjects on a study cannot be deleted from the system in any other area. Subject records can be removed from a study, based on the study status and subject status, but the subject record will remain in the system. This area allows you to delete a subject completely from the system.

After selecting this link, a page for finding a specific subject will display. You will have the ability to filter by Departments associated to subjects. After selecting the correct department, click the Find Subject button.

This will open a smaller window that contains several fields you can use to search for a particular subject. Enter the necessary information then click the Search button. Any subjects that meet your search criteria will list in the results, displaying MRN, Last Name, First Name and SSN (if using SSN in the system). If you locate the subject you want to delete from the system, click the icon in the Select column.

The subject you select will populate in the Select the Subject be deleted field. Click the Delete Selected Subject button.

The system will ask you to confirm the deletion of the subject. When you confirm, the subject and all corresponding records will be deleted from the system, including subject tasks completed by the subject. You will receive a notice when the subject record is successfully removed from the system.

Change Subject Following CRC

Within each subject record on a study, you are able to select a Following CRC. These Following CRC tasks can be transferred administratively allowing you to transfer tasks from multiple subjects to a new CRC at one time, as opposed to accessing each subject record and making the reassignment.

After selecting this link, the Change Following CRC page will open. You will have the ability to select a current Following CRC and transfer subjects to another user.

This page is broken up into two groups. The left side of the page is related to current Following CRC information. The right side of the page will contain information about the user you want to transfer the subjects to. Begin by selecting a user from the first drop down. This is the user you want to transfer tasks away from. If you do not know who the user is, you can select a department associated to the subjects below the current Following CRC drop-down list.

Once you make a selection from either drop-down list, the page will refresh with any subjects that are assigned to that user. The results display in the bottom portion of the page.

Next, select a user to transfer subjects to by selecting a user from the drop-down list on the right side of the page.

You can only transfer users who also have a role on the study that the subject is enrolled on. The screenshot below shows the ability to transfer subjects from one user on a study to another user on the study. Next to each subject is a checkbox allowing you to indicate whether to include the subject in the transfer. Checkboxes are selected by default. If you do not want to transfer over a particular subject, make sure the check box next to that user is not selected. Click the Transfer subject(s) to new following CRC and the system will move the subjects you selected to the new Following CRC.

If you need to transfer subjects to a user who does not have a role on the same study the subject is enrolled on, the ability to transfer will work a little differently.

In place of a checkbox next to the subject record, you will receive an indication that the user you selected to transfer to is not a KSP on the study. You can choose to add this user to the study by selecting a Research Support Role from the drop-down list then click the Add button.

The system will alert you that the user has been added to the study and you may proceed to transfer the subject to this user.

Any user you transfer a subject to will list as the Following CRC for that subject on the study in the On-Study Registration Information page.

Unlock Subject on Study

Unlock Subject on Study is a tool that can be used to open locked subject records for specific users on the study.

This tool is only used when your Subject Management module has the ability to add multiple subjects on a study at one time and you need to update an older subject record.

User Clean-up

This area is related to the LDAP login interface which iMedRIS offers as an additional interface to the software, if your institution has purchased this interface, this tool will assist in cleaning up duplicate account records, caused by unresolved LDAP configuration issues. It is very important that this area not be used for any resolution other than LDAP issues. If you feel this tool would be beneficial to your institution; please contact your Project Manager or Custom Support Representative before using this.

Merge User Account

The LDAP sign-in interface, interfaces with clients’ networks, the configurations for this setup are often extensive and if not setup correctly can cause the system to create duplicate accounts for a single user over multiple login attempts.

Note: This tool does NOT merge training records, ongoing study records and so forth; this is a basic merge tool for duplicate accounts that do not both have in-process active data.

This basic tool allows you to select the user accounts that you wish to merge. Once the accounts are selected the system will display applicable information related to those accounts, and request that you designate which account will be deleted.

Select the account that you wish to merge/delete and Delete Selected Record.

Workflow Clean-up

This area gives the System Administrator the ability to maintain workflow issues, and submissions out of cycle in workflow issues.

Workflow Submission out of cycle

Workflow Clean-up allows you to oversee active workflow issues and resolve them accordingly. If a workflow for a form was not created properly, often submissions will get stuck in a cycle and the system does not know how to proceed.

After selecting this link, a list of any out of cycle workflow issues will display. You will have the ability to View the workflow steps, as well as select to Move Submission on workflow issues you believe can be resolved.

View – When selecting to view the workflow steps will display the steps that were applied to the submission. This area will assist in pinpointing why the system did not know where to direct the submission.

Move Submission – Once the issue that caused the submission to be out of cycle has been resolved, checking the submission and selecting the Move Submission button, should then push the submission back into the workflow, so further steps can be taken. Please see the Workflow Manual for additional assistance on the Workflow Designer tool.

Note: If the issues with the workflow have not been corrected properly, the submission will remain on this screen, and still be listed as out of cycle. If the issue was correct, the item will remove from this area and will continue to the next step in the workflow.

CITI training Clean-up

This area is related to the CITI training interface which iMedRIS offers as an addition to the software, if your institution has purchased this interface, this tool will assist in cleaning up unmatched training records.

Merge Matchless CITI training records

Records coming from CITI training must match the records within iRIS. Training records from the feed need to map to users in the system by e-mail address or CITI ID. This means the e-mail address and CITI ID entered in the iRIS user account field must match the e-mail address stored within CITI. When this information does not match the system catches those records within this tool. Here you have the ability to merge these records with the correct user accounts in order to maintain consistency and accurate information.

After selecting this link, a list of the records (if any) will display. You will have the ability to Revolve matchless records, as well as Delete Selected Record(s). The name and email address in the screen shot below has been removed for security, as this image displays an actual matchless record.

Resolve – Selecting to resolve a record displays a Search User Directory screen.

From here the user account, which should be associated to the CITI record can be searched for, selected, and resolved.

Last Name / First Name / E-mail – Displays the personnel’s CITI information associated to the matchless record. (Removed from screen shot above for User privacy)

Group /Stage Number / Stage / Date Completed – Displays the CITI training information associated to the matchless record.

Once a record has been successfully merged to a user account, the record will be removed from this area and the user accounts Training information will update accordingly.

Selecting to Delete Selected Record(s) will allow records to be deleted without resolving. Remember to select the checkbox of the Record(s) that needs to be deleted, before selecting the delete button.

When records with different email addresses are imported into iRIS from CITI, iRIS will not recognize the secondary email address unless it has been added in the user’s profile (My Profile > My Account). If the user does not have their CITI user ID in their profile, there will be no association between the CITI record and the user.

System Administrators are also able to reconcile the matchless records due to conflicting email addresses. System Administrators can choose the two records and check them under Resolve on the left column, and then click the Resolve button on the right side. Once the different accounts have been reconciled, the secondary email address and CITI user ID will populate in the user’s profile.

Define Access

Define Access allows users to customize their feed columns. Users will be able to manually select which columns from CITI get pulled into their iRIS system by navigating through the different feed columns.

TMS Training- Matchless Records

Matching records from TMS Matchless Records when a user account is created, or an email address, or an additional email address is updated, a process to find matches will be trigged. In this process, the system will look for a match under the training import table and match the records with the user, instead of having users resolve an entry manually.

AALAS Training Records

The AALAS Interface will pull training records from AALAS into iRIS that has been created. Records coming from AALAS training must match the records within iRIS. Training records from the feed need to map to users in the system by e-mail address. This means the e-mail address entered in the iRIS user account field must match the e-mail address stored within AALAS. When this information does not match the system catches those records within this tool. Here you can merge these records with the correct user accounts in order to maintain consistency and accurate information.

Resolve – Selecting to resolve a record displays a Search User Directory screen.

From here the user account, which should be associated to the AALAS record can be searched for, selected, and resolved.

Last Name / First Name / E-mail – Displays the personnel’s AALAS information associated to the matchless record. (Removed from screen shot above for User privacy)

Group /Stage Number / Stage / Date Completed – Displays the AALAS training information associated to the matchless record.

Once a record has been successfully merged to a user account, the record will be removed from this area and the user accounts Training information will update accordingly.

Audits

The Audits tab allows a System Administrator the ability to Audit key components of iRIS for the entire system. The following sections of this manual describe the audit process in detail.

System Audits

System Audits allows you to oversee and run audits on several areas of the system at any given time.

Audit System Logins

Audit System Logins is a simple tool that allows the auditing of past and present logins by user. Selecting this tool automatically directs you to a page that displays logins for the past 7 days. Additionally, the amount of days the system displays can be adjusted and viewed as needed.

Logged in? – Displays whether the user was able to successfully login into the system.

Name – Name of the user.

Location – Displays the IP address the user is logging in with.

Browser type – Displays the browser type being used to login (this field is helpful in cases when a user is having an issue due to using a browser type that is not supported by iRIS).

Audit System Notifications

Every notification that is sent out by the iRIS™ system is logged and can be tracked. Since the system automatically generates the notifications, this notification audit tool can be very useful to track if notifications are being sent by the system to their intended users.

Clicking on this icon opens the following Audit Notifications screen with several filters to pull up the notifications you want to see.

Notifications will be displayed with fifty items per page. Selections can be made using the following filter tools:

Notification Type – Select a notification type from the drop-down list to filter by Notification Type.

Recipient(s) – Use this field if you wish to perform an audit for a specific user in the system who would have received the notification you are searching for. Only user(s) with entered criteria that have received notifications will be displayed.

When the Select User button is clicked, a new screen will be displayed (see below). Enter the search criteria and click the Find button.

When you have found the user, click the Select User Icon next to his/her name.

Once added to the search filter, you can clear a name by selecting the Clear User button. This tool will only allow for reporting of one user at a time, so if you happen to select more than one user on a page, only the topmost user will be selected and inserted into the search tool (shown in the screenshot below).

Additional filtering can be selected from the other fields on the page.

Date Range – If the approximate date of a notification is known, then this would be the best filter.

IACUC/IRB/Proposal/IBC Number – This depends on the selection made from the Display Projects by drop-down list.

Subject – Enter a key word or phrase that appears in the subject. Use the “%” to do a ‘wildcard’ search.

Content – Enter a key word or phrase that would appear within the content of the notification. Use the “%” to do a ‘wildcard’ search.

Provide information for one or all of the search fields to locate the necessary notification. Click the Search button and all of the results will be displayed in the table under the search engine, with the most recent notification being at the top of the page. You can sort the notifications displayed in ascending or descending order by clicking in the column headings (as shown in the screenshot below). This feature is not included in the View and Recipient(s) columns.

The following columns populate for your search results: View, Notification Type, <chosen> Number (IRB, IACUC, etc., depending what you chose to Display Project by), Date Posted, Subject, Recipient(s), and Additional Recipient(s).

Click the View icon to view the actual notification that was sent. You will see a screen similar to the screenshot below (information is read-only):

Audit System Events

This area of the system is a higher-level Administration Tool which is not available within this manual, please discuss with your Project Manager or Customer Service Representative before utilizing.

Display Audit Log