TOPAZ Protocol Research Compliance System
Migration of Protocols to TOPAZ
IACUC, IBC, RSC, and LSC compliance programs actively use TOPAZ, and all protocols have been migrated.
IRB: The new application for Expedited and Full Committee review is now open, and any new submission in these categories will now be submitted via TOPAZ. The Exempt category form is under development and will be released later this year.
Each active IRB protocol that has been previously approved will be migrated (copied) into the new protocol software (TOPAZ). Protocols must then be Submitted and Approved in TOPAZ. For your convenience, this process will be completed by Office of Research Compliance. TOPAZ sends automatically generated emails to alert you of the completion of this process.
While your previously approved protocol will be submitted and approved within TOPAZ, there are several new/updated questions that will need to be addressed the first time you edit your protocol in the new system. There are three possible routes to edit your protocol:
- Amendment – An Amendment protocol must be submitted if you need to make changes to an approved study. You can submit an amendment at any time during the lifetime of the study.
- Interim Review – An Interim Review protocol is submitted annually for certain types of protocols. During review you can make amending changes to the original protocol, if desired.
- Renewal – A Renewal Protocol is submitted every 3-5 years following initial approval (program dependent). Most renewal protocols are sent to full committee review. During renewal you can make amending changes to the protocol, if work outlined in the protocol has changed. Upon approval, renewals extend the expiration of the protocol for another 3-5 years.
When it is time for submission of an Interim Review or Renewal, you will receive an email from TOPAZ to notify you of the due date. Please refer to the user guide located in the TOPAZ User Guide section of this page for assistance.
Note: Protocols will have the original approval dates, for example, if your protocol has a 2019 approval date it will still expire in 3 years (or 5 years for IRB).
This training is for PIs, personnel, and students and who will be entering and amending human subjects research protocols in Topaz. As we roll out new IRB forms, we are now offering training for those who will be working with human subjects in the Expedited and Full Committee review categories.
This interactive BYOL (bring your own laptop) session will introduce you to the Topaz software system so that you can experience the Topaz application as it applies to you. The 1 hour session will cover:
- Basic navigation
- Dashboard review
- New form questions
- Creation and submission of protocols
- How to respond to committee review comments
- How to copy a protocol
- How to submit protocol amendments
Individual tutorial sessions are offered immediately following (available until 2pm).
Sign up to attend an IRB training session by emailing [email protected]. Sign up deadline is 2 days prior to the training date.
|IRB Expedited and Full Committee Applications||January 19||Hamilton Hall Conference Room #214||12pm - 1pm|
|IRB Expedited and Full Committee Applications||January 25||Hamilton Hall Conference Room #214||12pm - 1pm|
|IRB Expedited and Full Committee Applications||January 26||WebEx - SESSION FULL -||12pm - 1pm|
|IRB Expedited and Full Committee Applications||February 15||WebEx||12pm - 1pm|
|IRB Expedited and Full Committee Applications||March 24||WebEx||12pm - 1pm|
|IRB Expedited and Full Committee Applications||April 25||WebEx||12pm - 1pm|
One-on-One Training Session – If you would like to schedule a one-on-one training in any research compliance area, please contact the SME from your particular area.
This system will ultimately reduce the burden on principal investigators and provide other benefits such as:
- Committee Integration – All PI protocols from the different compliance committees will appear on the same PI dashboard. In addition, protocols from different committees can be linked if both pertain to the same research project.
- Single Sign-On – MSU NetIDs and passwords will be used for TOPAZ sign-on and CITI sign-on.
- Learning Management System – All individuals associated with projects requiring a committee protocol have been uploaded to TOPAZ’s Learning Management System. MSU, CITI and in-house training records are maintained on TOPAZ and associated with each individual. This learning management system eliminates the “tracking down” of training records by the PI.
- Improved Review Process – TOPAZ allows PIs to access their protocols and view the history, track changes, and review details including comments, assignments and PI responses. Review details can be seen throughout the life of the protocol.
- Automated Reminders – Automated messages will be generated for approvals, protocol reviews, and committee decisions.
- Integrated Amendments/Modifications – Amendments/Modifications are integrated and time stamped onto the original protocol, allowing for quicker amendments/modifications, reducing confusion, duplicative responses, and protocol discrepancies.
- Protocol Cloning Capabilities – Protocols can be copied to generate a renewal if a protocol is expiring or if a PI does not want to “start from scratch” on a new protocol. This allows pertinent information such as personnel and training records to be transferred over to the new protocol.
- Embedded Annual Renewals – Annual renewals will be integrated into the original protocol on TOPAZ. This eliminates paper based annual renewals that have been used.
- The website to access TOPAZ is: https://montanaprod.topazti.net/Elements/app/login/login.html?ReturnUrl=%2FElements%2F
- What is my username and password?
- Your username is your MSU NetID and password. For individuals new to MSU, you will need to request access to TOPAZ before being able to login into TOPAZ. ORC will need information from your request in order to set up your account. Please send request to Committee Administrator.
- TOPAZ does not have an auto-save feature. Please save as frequently as you are comfortable with, not losing important data.
- Do not hit “X” or any arrows (e.g. back button) on the web browser’s tool bar. The only time you can hit “X” is on pop-up or external windows.
Click the appropriate protocol module under the Compliance menu:
- Click on the Protocols button and select one of the following options:
- New protocol requests: To create and begin work on a new protocol or a renewal protocol, click the Protocols icon, select “Create Original Protocol” and select the appropriate protocol form.
- Amendments: To create and begin work on an amendment for an already approved protocol in TOPAZ, click the Protocols icon and select “Create Amendment Protocol”. Then you will select the protocol that you want to submit an amendment for.
- Annual Renewals: To create and begin work on an annual renewal for a protocol that is approved in TOPAZ, click the Protocols icon and select “Create Renewal Protocol”. Select the protocol for annual renewal.
- I am getting an error when I try to log into Topaz. What should I do?
- Try reloading the page in your browser.
- Renavigate to this Topaz login page and try again.
- Clear your browser cache.
- How do I see my protocols?
- The “My Dashboard” section is where you can access all of the protocols you are associated with.
- Or select the Protocols icon and select “Open Approved Protocols”, and all protocols you are authorized to view will be in the list.
- Why does my TOPAZ start page look different than my PI’s?
- TOPAZ is a role dependent application, which means based on your role, you will have different icons.
- What is my protocol number?
- Protocols are automatically assigned a reference number in TOPAZ once you begin working on it. The protocol number is assigned once your protocol has been approved.
- Where can I find the protocol number and approval dates for my protocol?
- The information button at the top left. This is an information sheet for the protocol and displays all information regarding the protocol.
- I can see my protocol, but why can’t I edit it?
- Click the information button to check the status of your protocol. If you have submitted it, then the protocol is in review process. If you need to make changes, you will need to wait for the protocol to be returned.
- Why aren’t the appropriate lab staff receiving emails about the status of my protocol?
- Check the “protocol associates” section to see if you have indicated that certain lab staff should be “key associates” and be receiving email notifications regarding your protocol.
- Why can’t my lab staff make changes to my protocol?
- Check to see if you have indicated that the certain lab staff are “Co-Investigators” for the protocol in the “protocol associates” section. Only the PI, Co-Investigators, Author and Creator can edit an existing protocol.
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