MAESTRO Version 2.0 Review System PI and Research/Approval Team Training Document

Transcription

1 MAESTRO Version 2.0 Review System PI and Research/Approval Team Training Document Questions and Helpdesk Support: Call Office of Research Compliance at or or Office of Research Compliance IRB website MAESTRO Login, Help & Training: 1

2 Overview and New Features of Maestro Version 2.0 What is Maestro Versions 2.0? Maestro Version 2.0 is the new version of the Maestro review system with an all new look and loaded with features and improvements which include a new user interface, a user dashboard, advanced menu system, user account control, PI/Co-PI Collaboration tools, notification system, advanced comment and revision system, certificate replacement system, and much more. With these new features, improvements, and capabilities Maestro Version 2.0 can now be expanded to be used by other institutions, organizations, and committees involved in a wide range of research and review activities. The Maestro V1 review system is currently used by NMSU s Office of Research Compliance to process applications for research activities involving human subjects for the Institutional Review Board (IRB). Maestro allows researchers to complete, submit and manage their application for research involving human subjects, throughout the IRB process. Maestro also provides a mechanism for managing training certificates as part of an active application. Automatic notifications are sent out via Maestro to notify users when their application and training certificates need renewal. 2

3 Maestro User s Guide All Maestro Users The following features are available to all Maestro users. Accessing the System and Logging In/Out How To Log In Go to in your Internet browser. Next click the MAESTRO Login link in the left sidebar. On the main login page type your NMSU user id and password in the Username and Password fields and click Log in. If you do not have an NMSU username you can request an account via the Click here to request access button below the login fields. This will drop down the following menu in which you must enter your full name, valid address, the username you wish to use for the account, as well as a short description of why you need access to the Maestro system. Once all the required fields are filled out simply click Request Access to apply for an account. 3

4 Once you have an account and have logged into the system you will be greeted with the new Dashboard Page. This is the main page of the new Maestro system and from here you can access all of the tools necessary to manage your applications. How to Log Out To logout of Maestro simply click the Logout link in either the upper right corner of the screen (A), or in the lower right corner of the screen (B). Session Timeouts Maestro 2.0 has a new feature called Session Timers that keeps track of the amount of time since your last activity on a given session. Activity may be anything from refreshing the page to saving changes to an application and the time remaining is displayed via the session logout indicator at the upper right corner of the screen (C). After you have been inactive for 25 minutes, the following notification will be displayed indicating you will have only 5 minutes left in the session before the system logs you out. If you continue to remain inactive than a 1-minute warning will be displayed as well. The system will automatically log you out after 30 minutes of inactivity. 4

5 How To Manage Your Maestro Account Managing your Maestro account is easy in version 2.0 with the addition of the My Account tab and the User Control Panel. Monitoring your Account Information A summary of your account information is always displayed on the Dashboard page when you first log in. However, if you wish to view your account information from any other Maestro webpage, you can simply hover over the My Account tab at the top of the screen to get the adjacent dropdown menu. This dropdown will also give an indication of how many unread notifications you might have. Clicking on the My Account tab itself will take you to the User Control Panel where you can manage your account settings and information. The User Control Panel If you wish to make changes to your account first go to the User Control Panel by clicking the My Account tab at the top of any Maestro webpage. Here you can modify your account settings and information (1), manage your notifications (2), and with authorized permission even add or remove personal proxies (3). 5

6 1.) Update Your Account Settings and Information Personal Information The Settings panel contains several editable fields that display your current information. To update your account information, simply replace the text in the appropriate fields with the new information and click the Update Information button. Fields marked with an asterisk ( ) are required fields and must be filled out in order to submit the change. Please note that your username and primary are determined by your NMSU account credentials and therefore cannot be changed from within the Maestro system. Since the primary address cannot be changed by the Maestro system, we have added the ability to enter a secondary address to which copies of the notification s will automatically be forwarded. Account Settings Also within this panel are four radio button toggles that correspond to the four available account settings you can change. A.) File Downloads determines how Maestro will attempt to open any PDF files you download to your system. Attachment This is the default setting and when it is selected any file you download will be saved directly to your default download location and you must open it from there. Inline This setting causes Maestro to use your browser s settings for how files should be downloaded. In most cases this will cause the browser to attempt to open the file in a new tab where you can then save it to your system. B.) Notification Popups controls whether the system will use pop-ups to alert you of important notifications. Enabled When enabled the system will display small popups at the bottom of the screen for all new unread notifications. Disabled When disabled the system will not display the popups but the notifications can still be found in the Notifications section of the User Control Panel page. C.) Badges toggles whether the Menu Bar at the top of each page will display the Badges icons when there are unread notifications relating to that page. Enabled When enabled the system will display the Badges as normal. Disabled When disabled the system will simply hide the badge icons though the notifications can still be found in the Notifications section of the User Control Panel Page. Disabling Badge icons does not affect whether Notification Popups will still be displayed. D.) Sounds governs whether the system also uses sounds when displaying an alert. Enabled When enabled the system will play a jingle sound will be used each time a Notification Popup is displayed. Disabled When disabled the system will only display the popup and it will not play the sound. Help & Hints If you forget what these settings do, you can always hover over the question mark to get helpful hints and information about that setting. 6

7 Profile Summary Popup In addition, clicking on the link at the top of the panel will allow you to view the user information summery popup that others will see when they view your account profile. In most cases, the popup should look similar to the panel displayed below. 2.) Managing Your Notifications As you use the Maestro system you will occasionally receive Notification popups at the bottom of the page such as the one pictured below. The Maestro system keeps track of all of the alerts you receive and displays them in a list on the Notifications section of the User Control Panel. In this list you can find what the alert was about, when it occurred, if it was simply an alert or an important warning, and whether or not you have read and acknowledged the alert already. Over time these alerts will build up and eventually span more than one page on the list. To scroll through the different pages in the list use the arrows at the bottom right corner of the panel (A). If you have seen a given notification and don t want it to pop up anymore click the checkbox under Read to acknowledge you are aware of it (B). Read items will appear in a lighter muted color. You can also use the Mark all 7

8 as read link at the top of the list to mark all unread notifications as read (C). If for some reason you wish for a previously read notification to start popping up again you can simply uncheck the box and it will do so. If you want to completely remove a notification from the list you can do so by clicking the red X on the right of the entry (D). Use caution, deleting an alert cannot be undone! If you wish to delete multiple alerts from the list please give a few seconds between each removal in order to give the system time to process your request. 3.) Managing Your Personal Proxies If you have been authorized to designate other users as Personal Proxies to your account, then you will see the Click here to manage personal proxies link under the Settings section of the User Control Panel. Clicking this will open up the Personal Proxy Management Window similar to the one shown below. To designate a user as your Personal Proxy first type the name of the user into the text field above the Add as Personal Proxy button (A) and then click the appropriate user from the resulting dropdown. Try to keep your search specific as there are many users in the Maestro system and only a few will have permission to be a Personal Proxy. Once you have selected the correct user, simply click the Add as Personal Proxy button to enable them as your Personal Proxy. You can have multiple Personal Proxies at a time and if you ever need to remove a user from being your Personal Proxy you can do so by clicking the red X to the right of their name (B). How to find additional help and information about the Maestro Review System If you have any questions or simply want to know more about Maestro please visit the help website either by clicking the link at the bottom of any Maestro webpage or by going to directly in your browser. If you encounter an issue not covered in either this document or the help website or want to submit a suggestion on how we can improve Maestro, you can contact The Office of Research Compliance via the link at the bottom of the page or by sending an to care@research.nmsu.edu You can also send suggestions to the Maestro team from the Maestro Help Website by clicking the Suggestions tab on the maestro help website or accessing this link on your browser: 8

9 How to Upload, Manage, and Update Your Training Certificates Managing your training certificates To manage your training certificates you can click the My Certs tab at the top of any Maestro webpage to access your User Certificate List. The list is separated into 3 sections: 1) Certificates that you have uploaded to replace an expiring or expired certificate and are active but are awaiting administrative review and verification 2) Certificates that have expired or are expiring soon for which an updated certificate still needs to be uploaded and approved as a replacement. 3) List of all your certificates that have been uploaded into Maestro. To view an existing certificate, simply click on the certificate s title and a pop-up pane will appear with the certificate details and a small preview image of the uploaded PDF. To download a copy of your certificate to your computer, click the Download link below the certificate image. 9

10 You can also use the following dropdown menu to manage your certificates by simply hovering over the My Certs tab instead of clicking on it. Here you can upload a new certificate, view the details of the listed expiring certificates, and submit a new certificate intended to replace an expiring certificate. If a certificate is currently or nearing expiration and is attached to an active application, it will be listed here with the expiration date highlighted in yellow. How to Upload Your Training Certificates In both cases, if you wish to upload a new certificate, you may click the Add New Certificate button and the Add New Certificate panel will be displayed. This panel allows you to (A) enter the certificate number; the name of the training course for which the certificate was issued; the agency associated with the training; the topic category of the training; the date of the training itself as well as the date the certificate expires. It also lets you attach a scan of the certificate as a PDF file (B). Fields with an asterisk ( ) are required fields and must be completed in order to submit the certificate. How To Update Your Expired Certificates Replacing an expired certificate is very similar to adding a new one; the only difference is that you must indicate which of the existing certificates the new one is intended to replace (C). 10

11 How to Create, Manage, or Edit Your Applications Managing applications via the Forms and Submissions Page Any Maestro user can manage their applications by clicking on the My Apps tab at the top of any Maestro webpage. This will take them to the Forms and Submissions page shown below where they can easily create new applications or monitor the status of their existing submissions. For most users there are only two main sections on this page. First there is the Available Form List (1) that displays a collection of form templates, sorted by department, which can be used to create a new application. To the right of each template is a display of the current version of that form as well as the date it was last updated. 11

12 Below this is the Your Submissions (2) panel. This section lists every application for which the user is the Primary Investigator and arranges them into categories based on their status. Each of these categories can be opened or collapsed independently by clicking the category title itself. Furthermore, the entire list may be sorted by clicking the fields at the top of the list and will sort them in either ascending or descending order depending on the direction of the arrow. These features allow the user to more easily locate the application they wish to find without having to sift through all the other applications they have. If this is still not enough, the user can have the list filtered using the search bar at the top of the display. For users who have been granted Proxy Permissions to act on behalf of another user, there is a third section known as the Proxy Submissions (3) panel. This segment functions exactly like the Your Submissions panel; with the exception that the applications listed within are not owned by the current user. Depending on the extent of the proxy permissions that have been given to the current user, there may be only a few applications listed here (for which the user is either a COPI or Proxy level team member), or many (as is the case for users acting as Personal Proxies to another user). Creating a New Application To start a new application in the Maestro system, simply click on the name of the type of form you wish to create in the Available Form List. This will create a new application in that category and automatically redirect the user to the page where they can fill it out. Please note that, in most cases, creating a new application automatically assigns you as the Principle Investigator for that submission. For users with Proxy Permissions creating a new application requires an additional step. Since Personal Proxy users are able to create applications on behalf of another user(s), there will be a window displayed asking the proxy to indicate which user will be the PI for the application they are creating. 12

13 How to Fill Out an Application and Ensure Required Information is Included The Application Editing Page When either creating a new application, or editing an existing one, you will be taken to the Application Editing page such as the one shown below. The contents of this page will differ depending on what form you are filling out but the general process remains the same. As a reminder, you can always hover over the question mark next to a question or field to get helpful hints and information about that field. Fields with an asterisk ( ) are required fields and must be completed in order to finalize and submit your application. 13

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15 1.) The Submission Toolbar This floating toolbar will always remain on your screen and provides access to the following useful features: Quick Save -- As the name suggests, the Quick Save function allows you to rapidly save any changes you have recently made to the application. Clicking this will also activate the Auto Save function if that feature remains enabled. Auto Save -- This feature is enabled by default and will cause the application preform a Quick Save every 5 minutes after the first manual save. Hovering over the button itself will indicate how much time remains before the next Auto Save, and at any time, you can click the Auto Save button to toggle the function on or off. Sticky Note -- Sticky Notes are small notes that you can leave for yourself or share with others. Clicking on the Sticky Note button will create a note such as the one shown here. Once the note is created, you can move it to anywhere on the page, resize it to fit your needs, and fill it with any message you like. You can then choose to share the note with another team member, which allows that person to view and edit the text thus enabling easier collaboration, or chose not to share in which case the note is only visible to you. If you have shared the note, and do not want others to move or resize it, than you can lock it in place using the padlock icon at the top of the sticky note. Get PDF The Get PDF button allows you to download a PDF copy of any of the five main sections of the application. These sections are Submission, Team, Certificates, Attachments, and Comments. Get Packet The Get Packet button works similarly to the Get PDF function, except it will download all five sections as a single unified packet. Toggle Tabs The Toggle Tabs feature allows the user to enable or disable the display of the navigational shortcut tabs along the side of the page. 2.) Navigational Aids Tabs Tabs are navigational shortcuts that appear along the side of the Application Editing page and allow the user to rapidly scroll to a desired section on the page. Since applications vary depending on the type of form being completed, these tabs allow for quick access to important locations, particularly in large forms with many sections. Top Button Located in the lower left corner of the screen, the Top button acts as a shortcut that will quickly scroll you back to the top of the application. 3.) General Info This is the first section of any form and always contains the most basic information about the application. This includes the Project Title and Project Summary text fields, which is where you would define the name of the project and a short 500-word description of it. The Previous Submission drop down list contains the list of active submissions that user has in the Maestro system and can be selected to identify a link between the current application and a previously submitted form. 4.) Submission Team Assignment This section is where you identify the team members of your project both those participating in the research as well as those who must be aware of the research and give sign off, the role each person plays which also can determine the approval routing level or order that each person will be notified that their review and sign off is required. To add a research and approval team member type in the person s name into the search bar and the system will display a list of possible matches. Select the person from the dropdown and then select the role that person will play on the project then click Add to Team button. The person will appear to the right of the team assignment section with the persons name, , role, and system routing level. 15

16 If the person is not in the pull-down list then you can manually add them by clicking the My team member is not in the list link. This will display a small window where you can type in the person s NMSU username and Maestro will attempt to locate them in the system. If user is found then the system will display the person s username, name, and address and ask you to verify it is the person you are looking for. After verifying that this is the correct person, simply click the Correct: Add Them button. The person will then be added to the Maestro system where they can now be added to the submission team assignment section. If the user does not exist in the NMSU database then the message Could not find a user with the specified username and will appear at which point you will need to contact support. After finding the person in the list of users, the person must be assigned a role and routing level for that team member. The level represents the routing order in which each research and approval team member needs to take action and sign off on the application. Team members playing similar roles should have the same routing level. Level 1 receives notification first then after all 1's have completed their approval then 2's and after 2's then 3's and so on. The default order is as follows: Co PI = 1 Faculty Advisor = 2 Department Head = 3 Research Assistants = 0 (they are identified as part of the team but won t go through the approval process or receive s; they are automatically listed as having approved the application. Other can be assigned any number (say 4) and represents some other role that may be played. 5.) Certificate Attachments To add or remove one or more certificates to your application, click the Choose a Certificate search field and choose the appropriate one from dropdown list of your team s active certificates. To remove a certificate from your application for a person simply click the red X to the right of the certificate you wish to remove. 6.) File Attachments The file attachments section is where you include the supporting files for your research, which may include consent or assent forms, the research instrument, as well as the proposal or grant if the research is funded by an agency, etc. Files may be added either by clicking the box below the File Attachments header and using the file select menu, or by simply dragging and dropping the desired files into the same space. Please note that PDF files are can be attached to an application and the current file size limit is 100MB. Please care@research.nmsu.edu if your attachment is larger than this limit or if you have problems attaching your file. To remove an attached file from your application, click the Remove File or red X button. 7.) Save, Finalize, and Delete Save The save button is used to save any edits made to the application. This button can be used in conjunction with the Quick Save button as well as the Auto Save function to help insure the entered information is recorded as efficiently and as timely as possible. Finalize The finalize button is used when the application has been completely filled out and the user is ready to route the application for review and sign-off by the team members. In order to do this, the user must first check the checkbox indicating acknowledging they have reviewed the document and that the information is accurate. After the last team member signs off the application during the Team Review process, the application will be automatically submitted to the Office of Research Compliance to begin the IRB review process. Delete The delete button can be used to delete an un-finalized application from the system. However, if the application has already been finalized and had been returned, deleting the application will instead render it as inactive and disable the user s ability to edit or submit it for review. 16

17 How to use the submission assistance (CARE form) checklist to minimize problems and possible resubmissions of my application when filling out the IRB New Application to Use Human Subjects in Research (Expedited or Exempt) form The submission assistance form (previously referred to as the CARE form) is provided as an aid for filling out the your IRB application. It can be used as a checklist to make sure you have filled out and included all necessary information and supporting documentation. Please note, that these items correspond to the IRB reviewer CARE form checklist items that will be used to add comments to an application for the PI during the review process when further clarification is needed or if items are missing. Some questions may have a reference to a particular item(s) listed in the submission assistance indicating that special attention should be taken to ensure that reference is addressed and provided in that question as well as all other related questions or supporting documentation. The submission assistance references are also provided in the tool tip section for that question. 17

18 Principle Investigators The following features are only available to users who are the Principle Investigator on a research team. And although users such as COPI s who have been identified with the role as COPI are also given proxy edit capability, no other member is authorized to finalize or submit an application. How to Finalize an Application If you are the Primary Investigator of an application and you wish to finalize that application, simply check the checkbox indicating you have reviewed the document and then click the Finalize button at the bottom of the Application Editing page. Errors on finalize After an application has been filled out and is ready for team signoff, the PI must click the Finalize button to begin the routing process. If any questions have not been addressed or if there are any problems with the contents of the answer text, a list of errors will appear and must be addressed before the application can be finalized. How to check the status of my team s sign-off After an application has been successfully finalized, the PI can monitor the sign-off status of each team member in the Submission Team Assignment section of the View Submission page for that application. This page can be accessed by first going to the Forms and Submissions page via the My Apps link at the top of any Maestro webpage; then expanding the Finalized Applications category in the Your Submissions panel, and clicking the View next to the desired application. To the left of each team member you will see an hour glass for pending sign-off and green check mark indicating the person has signed off. If a team member is still pending sign-off, the PI can click the envelope icon to have an notification reminder sent to the team member that review and sign-off is requested. How to Submit my Application to the Office of Research Compliance for IRB Review When the last team member has sign-off an application, then the application is automatically submitted to the Office of Research Compliance to being the IRB Review process. An will be sent to the PI and team members notifying them that the application has been submitted. How to Amend and Resubmit an Application During the IRB Review process, the committee may find questions or other elements of the application that require further detail or information. The IRB Chair or designated head approver reviewer will return the application to the PI with comments. The PI will click the Amend link to the right of the application, which will be located in the Returned Applications section of the submission list. After making the necessary changes to the application and acknowledging that each comment has been addressed, the PI will click the Finalize button to route the application back through for team sign-off and then resubmitted to continue the review process. How to review comments (general and by question) and revisions To review comments on a returned application, click the edit link to the left of the application that appears in the Returned Applications category of either the Your Submissions or the Proxy Submissions panels on the Forms and Submissions Page depending on your role in the application. On the Application Editing page there will be small word-bubble icons next to a question to indicate where a comment has been made about that field (A). Click or hover over the comment bubble to view the text of the comment(s). After viewing and making the necessary changes to address the 18

19 comment, be sure to click the addressed checkbox acknowledged it. next to the comment to indicate that you have After all comments have been addressed and you have saved your application, new revisions will be noted by the revision icon and an associated badge number (B). You can click or hover over the revision icon to view the associated revisions as well as the detail of the revision. Multiple revision tabs will appear if the application is returned and resubmitted multiple times. Using the tab control you can easily view comments and revisions and easily navigate to those comments throughout your application (C). Just click on the comment tab or revision tab to quickly scroll to that specific comment and/or revision section. After all comments have been addressed the application can be re-finalized, re-routed for team sign-off and resubmitted to continue the review process. 19

20 How To Proceed After Approval of an Application Once your application has successfully gone through the review process and been approved, you will receive an notification with a copy of your approved application packet with all supporting certificates and attached files as well as an approval memo. The application will be marked with an Approved status and will now appear in your Approved Applications section of your submission under My Apps. You can always access any of your applications no matter their states. Application Expiration Notifications You will receive Expiration Notification s when your application approaches it s expiration date. Expiration s are sent at 30, 60, and 90-day intervals as well as if the application expires prior to a continuation being submitted or a final report. It is recommended that you submit a continuation form if you need extension of time to continue your research. If your research project is complete then you must submit a Final Report form in order to have the project closed and marked completed. Both the continuation and final report form templates are located in your Available Forms List of your Forms and Submissions page. If an application does expire before a continuation is submitted, a new application must be filled out and submitted in order to conduct your research. Training Certificate Expiration Notifications Similar to approved applications, Expiration Notification s will be sent at 30, 60, 90-day intervals as well as if the training certificate expires. You must visit the training website and update your training certificate and then upload your updated certificate into Maestro but indicating you are replacing an expiring or already expired certificate. Application Approved with Stipulations Applications can be approved with stipulations which will be indicated in the approved with stipulation packet and memo. The application will be flagged and the stipulation recorded in order to document that the requirement has been made. Once the stipulation has been satisfied, then the application will be updated to an Approved state. Adverse Event Occurs during the research project If during your research some adverse event occurs, you must submit an adverse event form to the Office of Research Compliance to be reviewed by the IRB. Modification of Protocol Research Any modifications to your protocol or team members must be communicated to the IRB committee by filling out and submitting a continuation/modification form and indicating the reasons for the modification. Since the continuation and modification use the same form, it is also possible to submit a combination continuation & modification form should your project need extending in addition to documenting the modification of your research. Continuation of Research A continuation of your research project after the original approval must be submitted prior to the current approved application expiring. Completion of Research When your research project is completed, you will fill out a final report and submit it to the Office of Research Compliance to be reviewed and action taken to close out the application project and all related original parent and children applications. All application forms for that project will be marked as completed and no further action is needed. 20

21 Research and Approval Team Research and Approval Team members should review the application and its contents and then you re their electronic sign off of an application prior to it being submitted to the Office of Research Compliance. How to Review and Give Electronic Sign off of an IRB Application After the PI has identified you as team member of a research application and project, you will receive an when the PI has completed filling out the application and finalized the application. The application will have been electronically routed to the team members for review and electronic sign off. You can find the list of applications requiring your review and sign-off under the My Team Reviews tab on the menu of any Maestro webpage. Indicating Your Approval If after reviewing the application you concur and approve of the application you can click the Approve link to the right of the application. After all team members have signed off the application will be automatically submitted to the Office of Research Compliance to begin the IRB Review process. Indicating Your Dis-Approval If after reviewing the application, you do not concur with the project or if any changes need to be made or addressed, then you can choose to Dis-Approve the application by clicking the Reject link to the right of the application. Clicking the Reject link will cause the application to be returned to the PI in working state so that he or she can address any edits or concerns you may have. When the PI has made the necessary changes, he or she will re-finalize the application for Team Review. After the last team member has approved the application than it will automatically be submitted to the Office of Research Compliance to begin the review process. 21