CAYUSE IRB USER GUIDE VILLANOVA UNIVERSITY Version February

CAYUSE IRB USER GUIDE VILLANOVA UNIVERSITY Version: February 2019

CAYUSE IRB BASICS • The Villanova IRB uses an online protocol management system called Cayuse IRB for all applications, modifications, notifications, and other official communication about human subjects research. • Cayuse IRB is separate from other Cayuse services used for submitting grant materials, but run by the same company. • To be granted access to Cayuse, fill out the Cayuse Request Form available on the IRB website. • Anyone can have an account, but only faculty, post-docs, and Ph. D students may be Principle Investigators on applications. 2

GETTING STARTED: LOGGING ON 1. Logon URL: https: //villanova. cayuse 424. com 2. Sign on with your Villanova credentials 3. Select “Cayuse IRB” 3

GETTING STARTED: DASHBOARD Each time you log on you will be brought to your “dashboard” page that allows you to navigate to other areas of the site. Your Name This top pane summarizes the status of your submissions Click on the “bell” to access any notifications (e. g. study tasks or decision notices) Study Title 4 The “My studies” widget displays all of your active submissions Any pending tasks appear here Any approved studies appear here Soon to expire studies appear here Expired studies appear here

GETTING STARTED: CREATING A NEW STUDY Your Name 1. The blue “+ New Study” button in the upper right corner will allow you to create a new submission. 2. Clicking that button will bring you to the study details page. Type your study name and click the blue check box. You cannot easily change this title later on, so be sure about what you select. 5

GETTING STARTED: CREATING A NEW STUDY Your study status will be highlighted here. Your Name Study Title 1. Your study will be assigned a protocol number. This number will be used for the entire life of your protocol. To access the full application, click on the “+ New Submission” button, and then select “Initial”. 2. Click on “Assign PI”, which will lead you to the full application. 6

GETTING STARTED: CREATING A NEW STUDY Study Title - Initial The interactive form will offer different questions depending on which answers you select. Optional: Use the menu on the left to navigate through your submission. All personnel (including students) listed on your application must have completed all required CITI trainings and FCOI disclosure form. See irb. Villanova. edu for list. Move your way through the form. You may save and return later if needed. You will need to include information about your study background and rationale, design, measures, etc. 7 Note: Cayuse does not auto-save!

GETTING STARTED: CREATING A NEW STUDY The task bar on the left side of the screen will mark your progress through the application. A green check mark shows that all required questions in that section have been answered. Once all sections are complete, you will see a new option to Complete your submission. Once you do, it will be sent to: 1. ) PI and co-PI(s) for certification, 2. ) Selected person in your department who handles approval (e. g. dept. chair, dean), 3. ) ORP for pre-review to verify completeness 8

CONTINUED USE: REPLYING TO REVIEWER COMMENTS In many cases your application will be returned to you for changes before it is approved. Sections with reviewer or analyst comments will be highlighted in the sidebar. You can locate the “expand comments” bubble to view and respond to requests. Mark comments as “addressed” when you have done so. 9

MODIFICATION SUBMISSION You must seek IRB approval for modifications to your protocol including personnel changes, updates to your study instruments, or recruitment materials, etc. For exempt studies, see your determination letter for instructions about when a modification is necessary. 1. Login to Cayuse IRB and click on the study you wish to modify. 2. Click on “New Submission” and select “modification” from the drop down list. 3. Complete the modification cover page and make any necessary changes to the body of the main application. 10 4. When the application is complete the routing and “complete” buttons will appear in the sidebar to finalize.

RENEWAL SUBMISSION 1. Annual Renewals (full board studies/clinical trials) or Status Update Reports (expedited studies) must be completed each year before your expiration date Login to Cayuse IRB and click on the study you wish to renew. 2. Click on “New Submission” and select “Renewal” from the drop down list. 4. 3. Complete the Status Update Report or Annual Renewal form depending on your study’s review level. 11 When the application is complete the routing and “complete” buttons will appear in the sidebar to finalize.

CLOSURE SUBMISSION 1. 3. Close your study when you have completed all enrollment, data collection, data analysis, and manuscript preparation. Login to Cayuse IRB and click on the study you wish to close. Complete the closure report affirming that you have completed work on the study. 12 2. Click on “New Submission” and select “Closure” from the drop down list. 4. When the form is complete the routing and “complete” buttons will appear in the sidebar to finalize.

INCIDENT REPORT 1. 3. Notify the IRB via an incident report if there any unanticipated or adverse events during the course of your study activities. This includes any deviation from your approved protocol. Login to Cayuse IRB and click on the study on which you wish to report. Complete the incident report, providing as much detail as possible. 13 2. Click on “New Submission” and select “Adverse Event” from the drop down list. the form is 4. When complete the routing and “complete” buttons will appear in the sidebar to finalize. The IRB will contact you with any further information or action requests

GETTING STARTED: WORKFLOW PI creates protocol PI submits protocol Protocol is routed for Organizational Approval ORP is notified of your application before this point ORP receives protocol and conducts pre-review Protocol is returned to PI for revision or training issues PI returns protocol to ORP after revising Protocol is sent to reviewer Reviewer has up to two weeks to review initial submission. Most applications (aside from full board studies) are approved within this two week period. 14 Protocol Approved

KAITLIN GOTTUSO COMPLIANCE SPECIALIST, ORP EMAIL: KAITLIN. GOTTUSO@VILLANOVA. EDU IRBADMIN@VILLANOVA. EDU 610 -519 -5930 (OFFICE) CONTACT: irb. villanova. edu RANI MUTHUKRISHNAN DIRECTOR, ORP EMAIL: RANI. MUTHUKRISHNAN@VILLANOVA. EDU 610 -519 -4250 (OFFICE) SUZANNE SMELTZER CHAIR, IRB EMAIL: SUZANNE. SMELTER@VILLANOVA. EDU 610 -519 -6828 (OFFICE)

APPENDIX: MORE INFORMATION

HELPFUL HINTS • Cayuse does not auto-save your work! Be sure to manually save often. • Applications are sent to reviewers on Fridays in a “batch”. • Any complete application that is received by Thursday at 2 pm will be included in the weekly batch. • Be sure to allow time for organizational approval if you are trying to meet the Thursday deadline. • All communication about your study (confirmation of receipt, decisions, expiration notices) will come in writing via e-mail from irb@Villanova. edu. 17

HELPFUL HINTS • You can find monthly deadlines for the submission of protocols that will undergo Full Board review on the ORP website. • You can delete protocols that have not yet been submitted from the “submission details” page. Anything that has already been submitted must be withdrawn or closed. • Applications cannot be duplicated for ease of creating new protocols. • As a workaround, on the “submission details” page you can create a PDF of your application from which you may copy/paste. 18

SUBMISSION PROCESS • Once your protocol is submitted, ORP will verify that CITI training and f. COI requirements are up to date for all personnel listed on the protocol. • In certain cases you (PI) will also be able to verify CITI trainings for your research staff before you submit your protocol. This requires your students having a Cayuse account (see first slide). • Then reviewers will be assigned by ORP depending on the level of review required. 19

WORKFLOW ORP forwards complete applications to Reviewers on Fridays (if submitted by Thursday at 2 pm) PI submits protocol after completing Cayuse application PI ORP will send back to PI with reviewer comments or if submitted application is incomplete 20 Reviewer decisions (approvals or returns to PI) are sent to PI via ORP Reviewer has up to two weeks to review initial submission. Most applications (aside from full board studies) are approved within this two week period.

IRB OPERATIONS: TYPES OF IRB SUBMISSIONS 1. Initial Review • The first review of a human subjects research protocol. 2. Modifications • Modifications include changes to already approved protocols, like adding personnel, changing study measures or recruitment strategies. 3. Annual or Continuing Review • For many studies the IRB conducts an annual continuing review (full board) or status update (expedited) check. 4. Incident • An occurrence of any protocol violation, noncompliance, deviation, or serious noncompliance that is not consistent with the approved study procedures. For example, enrolling more participants than initially approved in your IRB application. 21

IRB OPERATIONS: TYPES OF IRB SUBMISSIONS (CONT’D) 5. Withdrawal • Used to withdraw an application from consideration by the IRB before it is officially approved. For example, when application sent in error or when you decide not to conduct the research. 6. Closure • Any study where all study procedures have been performed and data collection/analysis is complete. 7. Administrator Closure • Similar to ‘closure’ but initiated and performed by IRB Administration staff. 8. Administrator Withdrawal • Similar to a ‘withdrawal’ but initiated and performed by IRB Administration staff. 22

IRB OPERATIONS: TYPES OF IRB DECISIONS All decisions provided in writing! • Approved: The protocol is approved as submitted and research may begin. • Return to PI/Minor Stipulations: Reviewers will choose either of these decision types when they have identified issues the PI must address and revise before review can be finalized. • Exempt: This determination is given to protocols that meet a specific set of criteria laid out by the federal government. • Not Human Subjects Research: The IRB will sometimes give this determination if the research does not meet the federal definition of human subjects research and the activity is not subject to the regulations. No continued oversight required. 23