Axiom Mentor completed a number of updates to its popular Mentor IRB module. These updates are active and available to customers at no additional cost.
Show/Hide Assigned Reviewers – New Reviewer Role Settings
In order to give committees the freedom to make some reviewers visible to the PI and some reviewers visible/identified to the PI, we have moved the control for the visibility settings from the IRB Setup à System Settings 1 à Reviewers à Reviewer section (where it governed all reviewer assignments) to the Reviewer Role definitions. We copied the previous settings to all reviewer roles for each client so if you are happy having all reviewer roles with the same visibility settings, you need not make any changes. If you would like to set individual reviewer roles to be identified or have reviewer comments visible to the PIs, then you can go to IRB Setup à System Settings 1 à Reviewers à Reviewer Roles and select “Add/Remove” on the context menu. On the resulting table of reviewer roles, select “Edit” for the desired reviewer role and then scroll down to the form below the table where the role definitions are displayed in editable form. At the bottom of the list of role definitions you will find switches to Show/Hide the Reviewer Name, the Reviewer Comments and Reviewer Names on the Agenda.
Sequencing Reviewer Roles
We have added support for sequencing reviewer roles so that reviewers can be automatically notified only after specified assigned reviewers have completed their reviews.
We have added a new method to handle research coordinators (those individuals who can create and manage protocols on behalf of one or more investigators). The existing model for research coordinators requires an investigator (or an IRB administrator) to name one or more other users who are then authorized to submit new protocols on their behalf. This research coordinator role can be defined so that the research coordinators can access and manage all of the protocols belonging to their assigned PIs or only those protocols the research coordinators are assigned to.
There is also a super research coordinator role that can grant specified users the rights to add themselves to any user as a research coordinator and add any other users as research coordinators to their PIs. Some institutions have a research office that handles IRB protocol submissions and this role was necessary so that the IRB administrators don’t have to update who has these privileges.
The standard research coordinator role is based on the affiliation of one or more research coordinators with one or more PIs. This model prevents any user from submitting a protocol on behalf of any other user.
A new client, however, operates on the assumption that any user can create and manage a protocol on behalf of any other user (PI) as it is too cumbersome to keep up with the task of affiliating these research coordinators with specific PIs. So we have created a new research coordinator role: unaffiliated research coordinator. As this is a bit long, if you choose to use this role, you can relabel it as you see fit (e.g., research coordinator).
By default, the unaffiliated RC role is disabled so those Mentor IRBs that do not see the need for this role need not do anything. The unaffiliated RC role can be configured so that either all users can be an unaffiliated RC OR only a designated list of users can be an unaffiliated RC. An unaffiliated RC can create new protocols on behalf of any Mentor user and is automatically assigned to the protocols they create as an unaffiliated RC. They can thus manage all aspects of the submission of the protocol as well as all post approval reporting. Unaffiliated RCs can also add other users as unaffiliated RCs to their protocols. What unaffiliated RCs cannot do is access other protocols of their PIs if they are not already named as an unaffiliated (or affiliated) RC on those other protocols.
The affiliated and unaffiliated research coordinator roles are mutually compatible. That is, they can be used concurrently.
New Personnel Application Section
We have added a “Personnel” application section. This application section has built in data structures that link to the personnel listed on the protocol and allows you to specify the responsibilities and qualifications of each person listed on the protocol. It also can automatically display the training certifications (from the PI Documentation page) that you can access from the “Click here to view PI Docs” link on the view protocol page. You can also add your own questions that must be answered for each person listed on the study (not by each person, but questions that the PI or research coordinator answers about each person on the study).
This application section can then be used on amendments. When the PI wants to add or remove personnel on a study, they select the Personnel section on their amendment and then they can add personnel and mark other personnel to be removed from the protocol. These changes are held on the amended personnel section until amendment approval and then Mentor updates the personnel records on the protocol automatically.
Variables, Templates & Logic
We have added a number of new features for Mentor’s notification templates:
- Addition of variables for all protocol survey and application section questions.
- Addition of a [ROLE] variable to determine if PI is a Student or General Faculty (Mentor will use the custom labels for these values.)
- Addition of [PIFACULTYTYPE] variable: displays the Faculty Type value from the faculty profile on the user record.
- Addition of variables for each custom menu created on the Menus 2 setup tab.
- Addition of support for complex comparisons, including date comparisons and RegEx string comparison functions. These can be used within our existing IF/THEN logical operators.
- Addition of custom notification templates: if you need a separate template for certain situations and the IF/THEN logical operators are not sufficient, you can create additional notification templates and then choose from these templates when Mentor loads the notification email form.
- Addition of Discussion Notes templates: you can now define templates with canned blocks of text embedded within IF/THEN statements that will automatically output the appropriate block of text based on satisfaction of protocol data conditions in the IF/THEN statements.
Using Conditions for Individual Application Section Questions
Those of you who have setup Application Sections will know that you can set conditions on these sections so that a given section only appears if some condition is satisfied. Thus, you might have an application section that only appears if the PI requests waiver of informed consent.
We have applied the same method for setting conditions on individual questions. This allows you to set complex conditions (e.g. Full Board Review or Expedited Review protocols that answers “Yes” to a given multiple choice question in another form). The conditions allow for AND logic and OR logic. You can also use conditions in the context of branching logic surveys. Branching logic surveys are more limited since there is a one to one correspondence between answer option and the subsequent question. Adding conditions provides for a much richer logical structure.
Linking File Upload Questions to Protocol File Types
Mentor has long had a “File Upload” question type that can be used in Protocol Surveys and Application Section questions. A disadvantage of this question type is that the file(s) uploaded are only accessible by viewing the actual question on the protocol, they do not appear on the protocols list of files. To remedy this problem, we have added a feature to the file upload question (and the option to request file upload on specific options in a single- or multiple-select question). You can link new file upload questions to protocol file types. You can also link existing file upload questions to protocol file types, however, the linkage will only apply to new file uploads, not to files that were uploaded to these questions in the past.
Option to Require Explanation Field When Present
When a single- or multiple-select question is setup, you can request an explanation of the answer for some or all options selected. We have added on the Create New Question form an “Explanation is Required” check box below the “Request Explanation of Answer” check box when it is checked. Mentor then requires the respondent to have at least some text in the explanation field.
Tooltips, Tooltips, Tooltips!
You can now add tooltips to the following labels:
Submission Form Labels – all labels of fixed elements that appear on the Create New Protocol form. To access the tooltip, select “Tooltip” on the context menu on the label item in IRB Setup à System Settings 1 à Config à Submission Form Labels.
Menus 1 Labels – each menu now has a tooltip field. To access the tooltip field, click the context menu to the left of the menu title and select “Tooltip”.
Menus 2 Labels – each menu you create has a tooltip field on the Add/Edit form for the menu.
The tooltips should allow you to create shorter labels for these items while making available more extensive explanations. When viewed by the respondents, items with a tooltip appear with the icon to the left of the label.
You can now provide your own graphic for that icon that has always been available on protocol survey and application section questions. For example, you might prefer this icon: To change the icon used for all tooltips, go to Admin à Setup à System Config 2 à Custom Labels and scroll to the bottom of that tab and you will find an “Explanation of Question Mouse Over Icon” section where you can upload your own image. Please be careful to use small images. The two shown above are both 14 pixels x 14 pixels. Too large of an image will break formatting on the page and not look very nice.
Disable “Request Signatures” Button Until Required Items Complete
We have added an option to disable the Request Signatures button on the view protocol page until all required items on the protocol have been completed. This assures that the study personnel whose signatures are requested will review a completed protocol. You will find this checkbox on the IRB Setup à System Settings 1 à PI à Electronic Signatures for New Submissions (section) when you Edit the section.
Automatically Submit Protocol on Last Electronic Signature
We have added an option to automatically submit a protocol when the last electronic signature is received. You will find this checkbox on the IRB Setup à System Settings 1 à PI à Electronic Signatures for New Submissions (section) when you Edit the section.
Protocol Specific Conflict of Interest Reporting
While Mentor has a full COI/FCOI reporting system that integrates with the IRB system, many institutions have an independent general FCOI system in place and what they need is protocol specific conflict of interest reporting. We have developed a system for this reporting at the protocol level. Since it may be required that each person named on a study (PI, co-PIs, Research Coordinators, Research Assistants) must file an FCOI report, we have linked this function to the Electronic Signatures, since this is the only part of a protocol that is specific to each person on the protocol.
In the Development Queue
Here are some of the new features we have in our queue:
IRB Administrator Time Tracking on Protocols – We built into Mentor a check-in/check-out time tracking system that we use for our own staff when reviewing protocols. Several client IRBs have expressed an interest in using this system themselves so that they can get data on the amount of time their administrative staff spends on each protocol and in aggregate across multiple protocols. When this becomes available it can be limited to just committee administrators or extended to members as well.
Enable Explanation Field on Questions in a Table – Currently, when you set multiple choice questions to use the “horizontal array” option, Mentor formats the options as a horizontal array down the left side of the page. The labels are at the top and each question in the table uses the same set of options (much as a standard scantron course evaluation form looks). Presently, these questions do not support an explanation field if the user selects an option that you have set to require explanation. We will be adding support for the explanation field on these questions.
Ad Hoc Reporting System – With the development of a wide range of protocol data variables, we plan to create an ad hoc reporting system that will employ these variables so that the client can specify the variables to include, the filter parameters and the output format (spreadsheet or page). We think the variables will be more intuitive to use and arrange that traditional ad hoc reporting systems. We plan to also build into this reporting system scheduling of reports and automatic emailing of them to specified recipients.
Option to Arrange Order of Items on Create New Protocol form and View Protocol page – this would allow the client to define the ordering of items on the protocol. Currently that ordering is fixed.