TOPAZ Protocol Research Compliance System
Migration of Protocols from IBCOP to TOPAZ
Several steps have been taken to migrate approved IBC protocols from the previous software (IBCOP) to the new protocol software (TOPAZ). Each protocol that has been previously approved using IBCOP has been copied into the new form in 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. During review you can make amending changes to the original protocol, if desired. The Interim Review replaces the PDF Annual Review form that was previously used.
- Renewal – A Renewal Protocol is submitted every three years following initial approval. 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 three 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 expire in 2022.
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.
- Get to Know TOPAZ Brown Bag Sessions. Attend an interactive BYOL (bring your own laptop) brown bag session to experience the TOPAZ application as it applies to you. The 1-hour session consists of exercises to learn; basic navigation, dashboard review, creation and submission of protocols, how to respond to committee review comments, protocol amendment and review processes and utilizing the “copy” feature. Individual tutorial sessions are offered immediately following
- ORC will be holding training sessions on a weekly basis on how to navigate TOPAZ.
Due to COVID-19, all training sessions are cancelled until further notice.
All are at 12:00 pm - 1:00 pm *
|February 21, 2020||Hamilton 214|
|February 28, 2020||ABB 145|
|March 6, 2020||Hamilton 214|
|March 13, 2020||ABB145|
|March 20, 2020||Hamilton 214|
|March 27, 2020||ABB 145|
|April 2, 2020||Hamilton 214|
|April 10, 2020||ABB 145|
|April 16, 2020||ABB 145|
|April 24, 2020||Hamilton 214|
|May 1, 2020||ABB 145|
- One-on-One Training Session – If you would like to schedule a one-on-one training please contact the SME from your particular area.
- 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.
- The help function icon can be used if you have any questions. Hit the help button and an external window will open. You can search by keywords to find information within TOPAZ.
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 three-year 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.
- 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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