Getting Started with TOPAZ

Ascension Seton IRB submission process is facilitated through TOPAZ Electronic Protocol Application System. This system provides an efficient way to electronically track protocols throughout the IRB submission and review process. Any Ascension Seton PI without any UT faculty appointment must submit their human subjects research to the Ascension Seton IRB for review, through TOPAZ, by following the instructions below:

Note: If you are not on a Ascension Seton computer, you will need to install the Citrix receiver on your personal computer. This will enable you to navigate safely behind the Ascension Seton firewall. You will then go log on using the username and password provided above. You will be asked to change your password. If you need assistance, contact the Ascension Seton IS Help Desk at 512-324-1675. Once you have access to Citrix, contact Ascension Seton Research Administration at RA@seton.org or 512-324-8383 to request access to Topaz.

TOPAZ Training Center

Step-by-step guides, quick links and how-to videos are available to help you navigate TOPAZ in the TOPAZ Video Center.

How to Access/Log In to TOPAZ

This video covers getting to the TOPAZ login screen, logging in, issues with logging in and how to obtain a login.

How to Access TOPAZ Through Citrix

This video covers getting to TOPAZ using Citrix, downloading a Citrix receiver if you have not already and how to attach documents through Citrix.

How to See If Your Team’s CITI Training Has Been Uploaded to TOPAZ

When you complete your CITI training, you receive a Completion Report (certificate). This video shows you how to see if your report and the reports for your study team have been updated into TOPAZ.

How to View and Respond to IRB Stipulations in TOPAZ

This video shows how to view the stipulations (summary comments) when items are incomplete or missing during the IRB pre-review or when the IRB has stipulations on the Protocol Amendment such as the addition of a funding source or study location, increase in enrollment, etc.

How to Submit Financial Disclosures in TOPAZ

Be sure you have an account in TOPAZ before you start or use the TOPAZ Account Request Form to obtain your user account. DO NOT use your computer’s backspace or BACK button as those will eject you from the system. The TOPAZ system BACK button is at the bottom of the screen with the section number; it is safe to use this one. SAVE often while using the form.

  1. There are six sections to the form, but you will use only five.
  2. Section 1 automatically shows your name.
  3. Section 2 sets out Ascension Seton Policy 1000.46 Financial Conflict of Interest in Research: Disclosure Management and Reporting and requires you to attest that you have read it.
  4. Section 3 discusses CITI Conflicts of Interest Training and asks whether you have completed it in the last 4 years.
  5. Section 4 asks if you have anything to disclose and will allow you to make your disclosure(s) if you answer “yes.”
  6. Section 5 asks for your affirmation and e-signature and allows you to submit the form for further processing.
  7. Section 6 is for administrative staff only.

Ready to Begin Financial Disclosures in TOPAZ

  1. Access TOPAZ through the Ascension Seton Intranet under WEB APPLICATIONS; click TOPAZ Elements.
  2. Log in: Type your user name and current password in the first two boxes that are displayed.
  3. Choose CONFLICT DISCLOSURES on the next screen, then, move your mouse over the DISCLOSURES icon to see the drop-down menu.
  4. Click CREATE ORIGINAL DISCLOSURE and when the window opens click on STATEMENT OF FINANCIAL INTEREST. You will be in Section 1, which basically displays your name.
  5. Click the NEXT arrow button at the bottom of the screen to go to Section 2. Section 2 displays the Ascension Seton Conflicts of Interest Policy. Read it and complete the attestation.
  6. Click the NEXT arrow button at the bottom of the screen to go to Section 3. Section 3 displays information about CITI training. Answer the question about CITI training.
  7. Click the NEXT arrow button at the bottom of the screen to go to Section 4.
  8. Section 4 is where you will make your disclosure(s). If you have no disclosure(s) to report, click “No” and then click the NEXT arrow button at the bottom of the screen to go to Section 5. If you have disclosures to report click “Yes” and give the system about 3 seconds to refresh.   

If You Have No Disclosures

  1. Complete the attestation in Section 5. Click SAVE and enter your e-signature. This is the same as the one you used to log on to TOPAZ.
  2. Click SUBMIT (about ½ inch to the right of the SAVE button).
  3. A window will pop open. In it, click SET STATUS at the lower right-hand corner of the window.
  4. Enter your e-signature, click SAVE and SEND yourself the automated message.
  5. If you receive the automated message, you’re done!

If you did NOT receive the automated message, the submission failed. Log back into TOPAZ and look for UNSUBMITTED DISCLOSURE. Open it and repeat the process. Be sure to SET STATUS. To exit TOPAZ, click the drop-down arrow next to the black human figure icon at the top right-hand part of your screen where your name appears and select LOGOUT.

If You Have Disclosures

  1. After you click YES, the system will show a new field box entitled BUSINESS ENTITY LIST. If you do not see it, scroll down.
  2. Follow the directions to click the green + button and you will see 2 boxes. The left box contains an alphabetical list of companies. The right one will be empty.
  3. To choose companies you have interests in, click on the green + sign that appears on the left of their names. This action moves the company name into the big box on the right. Click all the companies you have interests with, then click OK to start the disclosure process.
  4. If a company you need to disclose is not on the list, you will need to request that it be added to the list. Send an email to COI@seton.org with a subject line of ADD BUSINESS ENTITY. If you are NOT a Ascension Seton employee, you will need to enter the name of your employer from the BUSINESS ENTITY LIST.    
  5. Once it is added you will receive an email to proceed with your disclosure.

Remember:

  1. Hit the SAVE icon that appears in the upper left-hand corner of the form often and
  2. Never use your computer’s BACK button or back arrows.
  3. NOTICE: For each BUSINESS ENTITY you selected the system will ask you questions about your relationship with that entity. The first questions are always about whether you do research with that company, are involved in business decisions with that company, or earn a salary (non-Seton) with that company. The remaining questions are labeled A through H and correspond to the list you saw in the instructions. Certain responses prompt the system to ask you more questions.
  4. After you complete information about each business entity you selected you will get to the end of Section 4. You will know you are there because there are no more boxes to enter information. At the bottom of the screen click NEXT to go to Section 5, which is the affirmation section.
  5. Read the affirmation statement, click the I AGREE button and click SAVE. The e-signature window will open and you will fill in your username and password. Click the SAVE button that is displayed in the window.
  6. Now click SUBMIT (icon that is 4 spaces to the right of the save icon). Another box will appear that is entitled SET STATUS with big blue letters that say SUBMITTED. Click SET STATUS at the bottom of the box. If you get an error message, see the last paragraph of this instruction sheet. Enter your username and password again and click SAVE in the window. A final box, “Disclosure Submitted for Approval,” will appear to indicate your disclosure was submitted. The system will offer to send an email to you. Click SEND and you are done.
  7. To exit TOPAZ, click the drop-down arrow next to the black human figure icon at the top right of your screen where your name appears and select LOGOUT.

NOTE: Section 6 is only for COI office staff. It is entitled “Management Plan.” You should not be able to enter any information in that section. At the bottom of the screen, click the Topaz BACK button to return to the affirmation screen (Section 5, where you will e-sign and submit) or Section 4 (which has the business entity choices and is where you make disclosures).

Error Message

A SAVE FAILED box will appear that will list any omitted items.

  1. Click OK. The SAVE FAILED box disappears. Now click CANCEL.
  2. Use the TOPAZ BACK button at the bottom of the screen to return to Section 4.
  3. Look on the far left-hand side of your screen. See the word OUTLINE.
  4. Move your mouse across the four symbols to the right of the word OUTLINE.
  5. Click on REQUIRED ANSWERS, and notice the extended outline that appears in the box below.
  6. Now click on UNANSWERED QUESTIONS and notice the subset that appears. These are required fields that you overlooked.
  7. Double-click the first one. It will take you to the relevant section. If you provided an answer already, double-click on the next item in the outline window and continue doing so until you exhaust the list within the Outline window. SAVE often.
  8. Return to Section 5 (Affirmation) and submit your disclosure again starting with Instruction #5.

TOPAZ Troubleshooting

Uh oh! If you are unable to find a protocol associate name on the staff list in Topaz, click on the next page button found at the bottom left of your screen. If you need technical support or receive an ERROR message in TOPAZ, let us know. We may know what went wrong, and if your issue cannot be resolved quickly, we’ll work with TOPAZ Support to resolve the issue ASAP.

How to Register on the CITI Website for First Time Users

  1. Go to http://www.citiprogram.org/default.asp?language=english and Select “Register” at the top right. Then follow these seven steps:
  • Step 1: Under Select Your Organization Affiliation, type in the search bar: Ascension Health and then Enter key.
  • Step 2: Fill out personal information and click the blue “Continue to Step 3” button.
  • Step 3: Create Your username, password, security question and answer. Then click the blue”Continue to Step 4″ button.
  • Step 4: Fill in gender, ethnicity, race and click the blue “Continue to Step 5” button.
  • Step 5: Indicate whether you want CE credit for CITI classes and if you wish to be included in CITI. surveys and click the blue “Continue to Step 6” button.
  • Step 6: Fill out Ascension Health requested information. Just select “Other” for courses you intend to take. That will be addressed in Step 7 and later.
  • Step 7: There are 4 questions on this step:
    • #1. Choose the learner group that best describes your role. (Note: You will have the option to change your learner group later.
    • #2. Select “No
    • #3. Leave it blank you don’t need any of these classes to do research at Seton
    • #4 Select “Yes
  • Then click the blue “Complete Registration” button
  • Click the blue”Finalize Registration” link.

You will be directed to your main menu, click the blue banner that says “Ascension Health Courses.” The course/module group options that appear here auto populated based on the learner group you picked in Step 7.

Registered! Now Start Taking Modules

Select the link with the name course you want to take. (Note: Upon completion of one group, you can complete modules in the other group if you believe it will be of benefit to your training.) The course will appear next with a list of required modules for that course, your current average score and a link to agree to the Integrity Assurance Statement. Click on the Integrity Assurance Statement link, read it, select “I agree” and select submit. You will be directed back to the course page where you can start taking the modules within the course. Click the blue link with the name of the module to begin.

Once Inside a Module: Read the educational information provided in each module, take a quiz covering that info. You must complete the quiz at the end of each of the required modules before you can proceed to the next module.

You can quit and return later any time during the taking of a group of modules, however, you must quit after taking the quiz for a particular module, not DURING the taking of that quiz, or your answers will not be recorded.

Returning Ascension Users Taking Refresher Courses

If you’re already a CITI user and have not taken your CITI basics refresher course in the last 2 years:

  1. Go to http://www.citiprogram.org/default.asp?language=english
  2. Sign in with your CITI username and password
  3. Under your main menu, choose Ascension Health courses
  4. Click on “Add a Course or Update Learner Groups” from the My learner Tools for Ascension Health sub-menu
  5. Select the course you wish to add and click Submit
  6. Return to your main menu

Returning Users from Other Institutions

If you are already a CITI user from another institution, log in and affiliate with Ascension Health.

  1. Go to http://www.citiprogram.org/default.asp?language=english
  2. Sign in with your CITI username and password
  3. Under your main menu, Choose “Click Here to Affiliate with Another Institution”
  4. Type in Ascension Health and click the Enter key or “Next” button
  5. Provide the demographic information required by Ascension Health
  6. Return to your main menu and you will see a new tab for Ascension Required Courses

How to Register for CITI Conflict of Interest Mini-Course

If the Conflict of Interest course does not already appear in your CITI main menu under Ascension Health Courses, you should add it:

  1. Go to http://www.citiprogram.org
  2. LOGIN using your CITI Username and password
  3. On your main menu, My Learner Tools for Ascension Health, select “Add a Course or Update Learner Groups”
    1. Under Question 1 identify your role
    2. Under Question 2 select “not at this time”
    3. Under Question 3 make sure nothing is selected
    4. Under Question 4 select “yes”
  4. Click the blue “Submit” button at the bottom
  5. On your main menu, under Ascension Health Courses, you’ll now see “Conflict of Interest”
  6. Click on the blue link “Conflict of Interest” to begin the course

How to Register for CITI Good Clinical Practice (GCP)

If the GCP course does not already appear in your CITI Main Menu under Ascension Health Courses, here’s how to add it:

  1. Go to http://www.citiprogram.org
  2. LOGIN using your CITI username and password
  3. On your main menu, My Learner Tools for Ascension Health, select “Add a Course or Update Learner Groups”
    1. Under Question 1 identify your role
    2. Under Question 2 select “not at this time”
    3. Under Question 3 make sure CITI Good Clinical Practice is selected
    4. Under Question 4 select “yes”
  4. Click the blue “Submit” button at the bottom
  5. On your Main Menu, under Ascension Health Courses, you’ll now see “Conflict of Interest”
  6. Click on the blue link “Conflict of Interest” to begin the course

Remember:

  1. Hit the SAVE icon that appears in the upper left-hand corner of the form often and
  2. NEVER use your computer’s back button or back arrows. 
  3. NOTICE: For each BUSINESS ENTITY you selected the system will ask you questions about your relationship with that entity. The first questions are always about whether you do research with that company, are involved in business decisions with that company, or earn a salary (non-Seton) with that company. The remaining questions are labeled A through H and correspond to the list you saw in the instructions. Certain responses prompt the system to ask you more questions.
  4. After you complete information about each business entity you selected you will get to the end of Section 4. You will know you are there because there are no more boxes to enter information. At the bottom of the screen click NEXT to go to Section 5, which is the AFFIRMATION section.
  5. Read the affirmation statement, click the “I AGREE” button and click SAVE. The e-signature window will open and you will fill in your username and password. Click the SAVE button that is displayed in the window.
  6. Now click SUBMIT (icon that is 4 spaces to the right of the save icon). Another box will appear that is entitled SET STATUS with big blue letters that say SUBMITTED. Click SET STATUS at the bottom of the box. If you get an error message, see the last paragraph of this instruction sheet. Fill in your username and password again and click SAVE in the window. A final box will appear “Disclosure Submitted for Approval” to indicate your disclosure was submitted. The system will offer to send an email to you. Click SEND and you are done.
  7. To exit TOPAZ, click the drop-down arrow next to the black human figure icon at the top right-hand part of your screen where your name appears and select “Logout.”

NOTE: Section 6 is only for COI office staff. It is entitled “Management Plan.” You should not be able to enter any information in that section. At the bottom of the screen click the Topaz BACK button to return to the Affirmation screen (Section 5, where you will e-sign and submit) or Section 4 (which has the business entity choices and is where you make disclosures).

Error Message

A SAVE FAILED box will appear that will list required items you forgot to fill out. Don’t worry about writing them down – the system has an easy way to find them.

  • Click OK. The SAVE FAILED box disappears. Now click CANCEL.
  • Use the TOPAZ BACK button at the bottom of the screen to return to Section 4.
  • Look on the far left-hand side of your screen. See the word OUTLINE.
  • Move your mouse across the 4 symbols to the right of the word OUTLINE to see what they are.
  • Click on the 1st symbol, REQUIRED ANSWERS, and notice the extended outline that appears in the box below.
  • Now click the 3rd symbol, UNANSWERED QUESTIONS and notice the subset that appears. These are required fields that you overlooked.
  • Double-click the first one. It will take you to the relevant section. If you provided an answer already, double-click on the next item in the Outline window and continue doing so until you exhaust the list within the Outline window. SAVE often.
  • Now return to Section 5 (Affirmation) and try to submit your disclosure again (pick up at Instruction #5).

International Air Transport Association (IATA) Training

We recommend Dangerous Goods Training through Mayo Medical Laboratories. Several other courses are available online. By law, any person who causes dangerous goods to be transported by a public carrier must follow specific regulations and must have proof of training. In a laboratory environment, send-out staff, those who transport dangerous goods, and those who receive dangerous goods are among those who require training.

Upon completion of this course, you will be eligible to take an online self-assessment quiz to obtain a Dangerous Goods Shipping training-completion certificate. This self-paced training and evaluation process is only one component of the client support offered by Mayo Medical Laboratories.

The process consists of training and a quiz. Complete the following steps:

  1. Watch the training video or read the materials.
  2. Take and pass the Dangerous Goods Shipping Certification quiz. After you sign in, click the “Start evaluation” button.
  3. Generate and print the Dangerous Goods Shipping certificate that launches automatically at the end of the quiz.
  4. Sign the certificate and have a trainer or supervisor at your facility sign as “Facilitator.”
  5. Retain a copy of the training-completion certificate and a copy of these training materials according to your laboratory’s procedures.

Initial SIRB Review

IRB Review is initiated by completing the Site Approval Tool. Approval from Ascension Seton IRB is required for all human subject research that will take place within a Ascension Seton facility including research that is limited to data use. The Site Approval Tool is a REDCap Form that navigates the PI and research team through a series of questions to evaluate the operational impact of research at each Ascension Seton facility or “site.” Begin this process once all study-related documents are obtained from the Sponsor (or created, for Investigator-initiated studies). Be sure to have all relevant materials available for reference and uploading before you begin. IRB Approval and Site Approval may be initiated in parallel; both are required before study commencement.