New TRACKS COI System: Committee Member Training Guide UAMS Conflict of Interest Compliance Straight Ahead New TRACKS COI System: Committee Member Training Guide

Sections in this PowerPoint: New TRACKS-COI System Committee Member Training Guide Sections in this PowerPoint: Completing a Basic Review Completing an Expedited Review Details about the new RBC (Research-Based Certification) process 4/12/2019 4/12/2019

Completing a Basic Review New TRACKS-COI System Committee Member Training Guide Completing a Basic Review 4/12/2019 4/12/2019

Option #1: click on the link in the email you receive from TRACKS. New TRACKS-COI System Committee Member Training Guide There are two options for logging into TRACKS-COI to complete your review. Option #1: click on the link in the email you receive from TRACKS. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide Option #2: go to http://coi.tracks.uams.edu/COI and log in using your UAMS username and password. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide You may access your assignments through your inbox or the meeting workspace (recommended). To navigate to the meeting workspace, click on Meetings on the left side of the page. In the meeting workspace, click on the meeting you wish to view. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide In the meeting workspace you can view the agenda items, assigned reviewers, SOP items, discussion items, and the minutes from the last meeting. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide To begin your review, click on the disclosure certification you want to view. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide Click on the History tab to view all activity related to this disclosure certification including Dean and Chair reviews, private comments, and any documents uploaded by the COI administrative staff. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide To view specific details about each disclosure, click on Printer Version and scroll through the form. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide Example of the printer version. Specific details about each disclosure are at the bottom of the page. 4/12/2019 4/12/2019

click the Close button or the back arrow. New TRACKS-COI System Committee Member Training Guide When you are ready to return to the discloser’s workspace to enter your primary review, click the Close button or the back arrow. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide When you return to the discloser’s workspace, you have several activities available: Submit Primary Review – enter your comments, propose a motion, and add documents. This step should be completed before the committee meeting. The next slide shows the steps of this activity. Log Comment – these comments can be viewed by all users: the discloser, dean, chair, other committee members and the COI administrative staff. Log Private Comment – these comments cannot be viewed by the discloser. They can be viewed by the dean, chair, other committee members and the COI administrative staff. Send Email – choose the recipient(s) and send an email requesting or providing more information. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide How to submit your primary review Enter your comments. Propose a motion. Add any related documents. Click OK. 4/12/2019 4/12/2019

Your review is complete after you submit your primary review. New TRACKS-COI System Committee Member Training Guide Your review is complete after you submit your primary review. To close this disclosure and return to the meeting workspace, click X on the browser tab. 4/12/2019 4/12/2019

expedited reviews, discussion items and SOP items. New TRACKS-COI System Committee Member Training Guide Please review SOP items, discussion items and expedited reviews before the meeting. Click on the link to the agenda and open the document to view all agenda items, expedited reviews, discussion items and SOP items. To view more details on each SOP item, click the link to the specific discloser’s workspace. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide The last step you should complete before the meeting is to confirm or decline your attendance. 4/12/2019 4/12/2019

Completing an Expedited Review New TRACKS-COI System Committee Member Training Guide Completing an Expedited Review 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide The Primary Reviewer will receive the first email notification from TRACKS. Click on the link in the email. When you log in, you will be taken to the discloser’s workspace to begin your review. 4/12/2019 4/12/2019

Click Printer Version to review the entire disclosure certification. New TRACKS-COI System Committee Member Training Guide As with the basic review, click the History tab to see all activity and uploaded documents related to this review. Click Printer Version to review the entire disclosure certification. 4/12/2019 4/12/2019

As with the basic review, you have several activities available: New TRACKS-COI System Committee Member Training Guide As with the basic review, you have several activities available: Submit Primary Review – enter your comments, propose a motion, and add documents. Log Comment – these comments can be viewed by all users: the discloser, dean, chair, other committee members and the COI administrative staff. Log Private Comment – these comments cannot be viewed by the discloser. They can be viewed by the dean, chair, other committee members and the COI administrative staff. Send Email – choose the recipient(s) and send an email requesting or providing more information. Please submit your primary review as soon as possible to move the certification along in this expedited review process. 4/12/2019 4/12/2019

Your review will approve or disapprove the primary reviewer’s motion. New TRACKS-COI System Committee Member Training Guide After the primary reviewer completes his/her review, the secondary reviewers will receive an email notification with a link to the disclosure certification. The primary review details are under the History tab. Your review will approve or disapprove the primary reviewer’s motion. 4/12/2019 4/12/2019

When you have completed your review, click on Submit Secondary Review. New TRACKS-COI System Committee Member Training Guide When you have completed your review, click on Submit Secondary Review. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide 1. Click Add on the first screen. 2. Enter your name on Q1. Choose Approve or Disapprove on Q2. Enter comments if you have any. Click OK. 3. Click OK on the first screen to submit. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide The COI administrative staff will record the expedited review decision and send the correspondence. 4/12/2019 4/12/2019

Details about the new RBC (Research-Based Certification) process New TRACKS-COI System Committee Member Training Guide Details about the new RBC (Research-Based Certification) process 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide When ORSP receives a notice of award, those listed on the project as Principal Investigator/Project Director, Key Personnel, or Other Significant Contributor (any person involved in the design, conduct, or reporting of research) will receive an email notification from TRACKS-COI to complete the RBC. Click on the link in the email you receive from TRACKS . Log in using your UAMS username and password. 4/12/2019 4/12/2019

Click Edit to be taken to your certification. New TRACKS-COI System Committee Member Training Guide Click Edit to be taken to your certification. 4/12/2019 4/12/2019

Answer the six questions (shown on the next slide) and click Continue. New TRACKS-COI System Committee Member Training Guide Review your previous answers, change answers as needed, and click Continue until you get to the Research Based Disclosure page. Answer the six questions (shown on the next slide) and click Continue. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide RBC Questions Are any of the reported financial interests related to the project listed above? f yes, please explain how each interest is related to this research. Are any of the reported financial interests in an entity that: 2a. Owns, manufactures or distributes a drug, compound, device or other product being tested or used in this project? If yes, provide details. 2b. Owns, manufactures or distributes a product that, to the best of your knowledge, competes with the drug, compound, device or other substance or article being tested or used in this project? If yes, please explain. 2c.  Will have a collaborative role in this project or will receive or provide materials or data used or generated in this project? If yes, please explain. 2d. Would benefit from receiving your research results before the results are made publicly available? If yes, please explain. Have you reported any licensed intellectual property (IP) or income from IP rights related to technology used in this project? If yes, please explain what the IP is and how it relates to the research. If you answered "yes" to question 3, does this research involve the evaluation or enhancement of the IP? If yes, please explain. Could an expert in your field reasonably determine there is a relationship between this project and any of your reported financial interests? If yes, please explain. Do you have any relationship with the entity funding this project? If yes, please explain. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide To submit your RBC, click on the box on the bottom left and then click Finish. 4/12/2019 4/12/2019

New TRACKS-COI System Committee Member Training Guide RBC certifications will be assigned to a monthly meeting for a basic review or as an SOP item, or they will be assigned for expedited review. 4/12/2019 4/12/2019

New TRACKS-COI System How to Submit Your Annual Disclosure TRACKS-COI Disclosure System http://coi.tracks.uams.edu/COI/ UAMS Conflict of Interest Office 501-686-6447 or 501-686-6168 PRPrincipe@uams.edu or WLAshley@uams.edu http://coi.uams.edu/ 4/12/2019 4/12/2019