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Ryan Bartlett, ryan.bartlett@montana.edu, (406) 994-6733

MSU office of Research Compliance


Table of Contents

Research Protocols

Definitions

Creating an Original Protocol

Navigating the form

Completing form

Opening a Saved Protocol

Creating an Amendment Protocol

Creating an Interim Review Protocol

Creating a Renewal Protocol

Submitting a Protocol

Editing a Protocol: Returned for Modification 


Montana State University (MSU) utilizes TOPAZ Elements to manage protocols associated with the Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), Institutional Review Board (IRB), or the Institutional Animal Care and Use Committee (IACUC). This guide will serve as an overview of the process of submitting protocols in TOPAZ. TOPAZ can be accessed using the button at the top of the main MSU TOPAZ page.

Please note, some images will vary based on permissions granted depending on your role (e.g., PI, Administrator). 

Research Protocols

The following sections explain how to manage a research protocol in TOPAZ. The tutorials cover all of the submissions you will be required to submit throughout the lifetime of the study to include: an original protocol, annual renewal(s), and amendment(s). 

Definitions

  1. Original Protocol – An Original Protocol is the first submission of your study. In an Original Protocol, you are submitting new research for its first approval period. 

  2. 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. 

  3. Interim Review – An Interim Review protocol is submitted annually following initial approval and again annually after approval of renewal protocols. During review you can make amending changes to the original protocol, if desired. 

  4. 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. 

Creating an Original Protocol

A Original Protocol is the first submission for your study. In an Original Protocol you are submitting new research for its first approval period. 

  1. Go to the TOPAZ login page 

    • Bookmark this page for easy access.
    • Login with your MSU NetID and Password.
  2. Click the appropriate protocol module under the Compliance mene

     protocol module

  3. Hover (with your cursor) over Protocols and a menu will appear. Select Create Original Protocol.select create originial protocol

  4. In the Select Form window, seleft that appropriate protocol for your research.protocol

Navigating the Form 

  1. Once you have selected the form, the screen will display the protocol screen with an Outline of the sections and corresponding questions. 

    The Outline section is indicated below. Use this to quickly navigate between sections. outline selection

    You may hover over each button in the Outline to see each function. each function

     

Answer each question of the sections and click Next at the bottom of the section. To return to a previous section, click the Back button at the bottom of the page. 

Note: Do not use the browser’s Back button to navigate to a previous section. 

Reminder: Click the Save button at the top of the form often – before moving to a new section of the form is a good point to save.icons you will see

Completing the Form

This section will outline how to complete protocol forms. Examples of common question types are shown below. 

There is no auto-save feature in TOPAZ, so save often to ensure information is not lost. To save progress on the form, click save button at the top left of the page. After saving the protocol, you can exit Topaz and re-access the saved protocol at a later time. See the Opening a Saved Protocol section. 

 

save

Note: Many of the questions will expand after answering a ‘Yes’ or ‘No’ question. Be sure to answer all parts of the question. 

  1. Selecting PI/ Personnel

    When adding personnel to the protocol, utilize the add personbutton to bring up the staff list. Select the correct staff from the list. 

    • You may filter by first or last name by clicking the 3 vertical dots next to the column header. 

    • Click on Filter and select the filter option. filter

    • Enter the desired filter parameters and click Filter  

    • Select the role for each staff based on the description in the section. 

      • Co-Investigators have the same privileges as the PI. 

      • Key Associate does not have any editing privileges but will receive email notifications. 

      • If no role is selected, associates are able to view the approved protocol only. 

    • Do not fill in the Responsibilities or Comments boxes. comments or responsibilities

    • You can click the info button to bring up the staff’s information. Click on the Staff Competency tab to show current training records. These records are automatically uploaded to TOPAZ and the PI/Lab Manager does not need to input training dates. 

       

  2. Pre-Populated Lists

    Many questions of the protocol will have the ability to select responses from a pre-populated list. Use the add to add rows to the table. In each cell with a drop down, select the proper response. Other cells in each row will need manual input. 

    prepopulated lists

    If the pre-populated list does not contain your required answer, the following questions will allow for manual input of information. 

    Use the add to add rows to the table and enter all required information for each row.manual info

  3. Required Questions

Many questions throughout the form are required to be answered. These questions are marked by required button

required questions

Ensure that all required questions are answered as you progress form. You can use button in the Outline panel to navigate to all required questions. The number below the required problem in the Outline panel changes as you answer questions and save the form. 

Once you have answered all of the required questions, the form has now been completed and is ready to be submitted. See the Submitting a Protocol section for next steps. 

Opening a Saved Protocol

After saving an unsubmitted protocol, you can access it at a later time by following the steps below. 

  1.  Go to the TOPAZ login page at http://www.montana.edu/orc/topaz/topaz.html. 

    •  Login with your MSU NetID and password. 

  2. Click the appropriate protocol module under the Compliance menu. 

  3. Hover (with your cursor) over Protocols and a menu will appear. Select Open Unsubmitted Protocols.unsubmitted protocol

  4. Click on the protocol that you wish to open. protocol

  5. The protocol will open, and you can continue to edit the form.

Creating an Amendment Protocol

The steps below outline how to create an Amendment Protocol. An Amendment Protocol is used to add new information to a previously approved protocol. 

  1. Go to the TOPAZ login page at http://www.montana.edu/orc/topaz/topaz.htm

    • Bookmark this page for easy access. 

    • Login with your MSU NetID and password. 

    • Note: To access TOPAZ from off-campus, you must sign into the VPN (i.e. Cisco AnyConnect). 

  2. Click the appropriate protocol module under the Compliance menu.                                             .compliance menue                                              

  3. Hover (with your cursor) over Protocols and a menu will appear. Select Create Amendment Protocol. amendment protocol



  4. In the Select Protocol for Amendment window, select the protocol you wish you amend. select protocol

  5. In the Select Form for Amendment window, select the appropriate form for your research. approperiate form

  6. Provide a brief description of the Amendment in section 1.1. 

  7. Add information to applicable sections of the protocol as needed. 

  8. After adding all applicable information, Save and Submit. 

Creating an Interim Review Protocol

The steps below outline how to create an Interim Review Protocol. 

  1. Go to the TOPAZ login page at http://www.montana.edu/orc/topaz/topaz.html
    • Bookmark this page for easy access. 
    • Login with your MSU NetID and password. 
  2. Click the appropriate protocol module under the Compliance menu.                         menue

  3. Hover (with your cursor) over Protocols and a menu will appear. Select Create Interim Review Protocol.review protocol

  4. In the Select Protocol for Interim Review window, select the protocol you wish you renew. 

  5. In the Select Form for Interim Review window, select the appropriate form for your research. 

  6. Answer question 1.1. 

  7. Update required sections (i.e. annual equipment certification dates). 

  8. If the protocol requires changes, edit the applicable sections, save, and submit 

  9. If the protocol does not require changes, save and submit. 

Creating a Renewal Protocol

The steps below outline how to create a Renewal Protocol. 

  1. Go to the TOPAZ login page at http://www.montana.edu/orc/topaz/topaz.html. 
    • Bookmark this page for easy access.
    • Login with your MSU NetID and password.
  2. Click the appropriate protocol module under the Compliance menu.                           menue
  3. Hover (with your cursor) over Protocols and a menu will appear. Select Create Renewal Protocol. renewal protocol

  4. In the Select Protocol for Renewal window, select the protocol you wish you renew. select protocol

  5. In the Select Form for Renewal window, select the appropriate form for your research. 

  6. Answer question 1.1. 

  7. Update required sections (i.e. annual equipment certification dates). 

  8. If the protocol requires changes, edit the applicable sections, save, and submit 

  9. If the protocol does not require changes, save and submit. 

Submitting a Protocol

You can submit a protocol that is currently open and being worked on, or you can submit a previously saved protocol. 

If submitting a previously saved protocol, open the desired protocol by following Steps in the Opening a Saved Protocol section. 

Once the desired protocol is open and is ready to be submitted, click the Submit button at the top of the protocol. 

submitting protocol

This will open the E-Signature Information window. Click Sign at the bottom of the window. This will open a second window for you to enter your NetID and Password. 

Editing a Protocol: Returned for Modification

This section will outline how to address comments on a protocol that has been returned for modification. The protocol may be returned after a pre-review, or after committee review. 

The investigator will receive an email that the protocol has been returned for modification. Follow the link in the email to log in and open the protocol directly. 

The protocol may also be accessed by: 

  1. Logging into Topaz and selecting the appropriate protocol module under the Compliance menu. 
  2. Hover over Protocols and a menu will appear. Select Open Returned Protocolsopen returned protocol
  3. Click the protocol that you wish to open. protocol wish to open

  4. The protocol will open and can be edited to address the comments.

Once the protocol has been opened, address the comments by using the Outline panel. The Outline will show how many comments have been left for the protocol and will allow you to quickly navigate to the specific sections. 

  1. Click on the Questions with Previous Submission Summary Comments button in the Outline. outline

  2. This will narrow down the Outline panel to only those sections with comments. Click on a section to open it and view the comments. outline comments

  3. The comments will appear on the right side of the protocol. Each comment will show the specific section number and will have a text comment that needs to be addressed. You may address comments directly in the section by editing the questions, or if no edits are necessary reply to each comment by clicking the Reply button next to the time stamp in the comment. reply

  4. Use the Outline panel to navigate to the next section with comments. Address all comments, remembering to Save often. 

  5. After all comments have been addressed, select Submit and apply the E-signature.