NYU Cayuse IRB Manual
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1 IRB NYU Cayuse IRB Manual prepared by the NYU UCAIHS (University Committee on Activities Involving Human Subjects)
2 What is Cayuse? The Cayuse Research Suite is NYU s system to support the submission of proposals to external sponsors (Cayuse 424). It also allows for management of the proposal submission and award process and provides a framework for tracking and reporting on sponsored project activities (Cayuse SP), as well as the submission of protocols to NYU s IRB.! First time accessing Cayuse? Make sure to register for the Cayuse Research Suite at NYU s Cayuse Resources page. If you try to log in and see a message that your account has been disabled, please register using the above link. Seeing this message means your account has not yet been created. 2
3 Logging In There are two ways to log into the Cayuse Research Suite: Navigate to nyu.cayuse424.com. If you are not already logged into NYU Home in the current browser, you will be asked to enter your NYU Home credentials. In NYU Home, click the Research tab and find the link for the Cayuse Research Suite under the eresearch Toolkit. 3
4 Once you are logged into the Cayuse Research Suite, click the link for the Cayuse IRB module 4
5 Table of Contents Creating a New Protocol in Cayuse IRB...6 Checking the Status of an Existing Protocol...17 Creating a Modification (Amendment) in Cayuse IRB...22 Creating and Submitting a Renewal...31 Where to find your documents...38 Submitting an Incident Report...41 Submitting a Study Closure...48 Editing and Submitting a Reopened Submission
6 IRB Creating a New Protocol in Cayuse IRB 6
7 To begin a new protocol, click New Study 7
8 Add Study Title here Click here to confirm creation of new study 8
9 Click here and select Initial to add a new submission to your study 9
10 Click here to begin editing your submission Remaining tasks 10
11 Questions marked with a red star are required Once all required questions in a section are complete, a green check will appear next to the section Starred attachments must have something uploaded. If n/a, upload a Word doc stating such. 11
12 For student research, the faculty sponsor MUST be the PI Only the Primary Contact, Primary Investigator, and Co-Investigator can access the IRB study 12
13 Make sure to save your work! 13
14 Select COMPLETE SUBMISSION to send the submission to the PI to certify. This option will not appear until all sections of the application are complete. 14
15 The PI must certify the submission in order for it to be submitted to the IRB 15
16 Once certified by the PI, the application is submitted to the UCAIHS and placed in Pre-Review 16
17 IRB Checking the Status of an Existing Protocol 17
18 Click Studies for a list of all your protocols. Click the IRB Number of the protocol you are interested in. 18
19 Click Submissions on the Study Details page for a list of submissions related to the protocol 19
20 Click the link for the submission you are interested in 20
21 Click the Task History tab to view activity on the submission 21
22 IRB Creating a Modification (Amendment) in Cayuse IRB 22
23 On the Dashboard, click here to view your studies 23
24 Click on the Study you wish to submit a Modification (Amendment) for Only the PI, PC, and co-pi can view or edit the Study. 24
25 Click New Submission then select Modification Only one Modification may be open at a time. Once approved, you may submit additional Modifications. 25
26 Describe and check off all items that are being changed (please include names of new personnel in the description of changes as well as the Research Personnel section) 26
27 Be sure to make all applicable changes in all sections 27
28 *DO NOT DELETE ANY DOCUMENTS THAT ARE STILL BEING USED* Only upload documents that have changes. Please include the date in the file name. When all information has been updated, click COMPLETE SUBMISSION to submit to PI for certification 28
29 The submission will remain at Awaiting Approvals and will not go to the IRB until the PI has certified the Modification 29
30 The PI can Certify the Modification by clicking here (refer to the start of the Modification guide for directions on navigating to this page) 30
31 IRB Creating and Submitting a Renewal 31
32 On the Dashboard, click here to view your studies 32
33 Click on the Study you wish to submit a Renewal for 33
34 Click New Submission then select Renewal 34
35 Click Edit to begin working on your Renewal 35
36 Please answer all questions in each section 36
37 Once all sections are finished, click COMPLETE SUBMISSION to send to the PI for certification Submitted Renewals are scheduled to be approved as close to the expiration date as possible 37
38 IRB Where to find your documents 38
39 For stamped documents, look under Study Details and click the Attachments tab Click the ellipsis next to the document you wish to view and select Download 39
40 Click the Letters tab under the Submission Details to view and/or print your letters 40
41 IRB Submitting an Incident Report 41
42 On the Dashboard, click here to view your studies 42
43 Click on the Study for which an Incident will be entered 43
44 Click New Submission then click Incident 44
45 Click here to begin editing the Incident report 45
46 Be sure to answer all questions 46
47 When finished, click COMPLETE SUBMISSION to send to the PI for certification 47
48 IRB Submitting a Study Closure 48
49 On the Dashboard, click here to view your studies 49
50 Click on the Study which will be Closed 50
51 Click New Submission then click Closure 51
52 Click here to begin editing the submission 52
53 Be sure to answer all questions 53
54 When finished, click COMPLETE SUBMISSION to send to the PI for certification 54
55 IRB Editing and Submitting a Reopened Submission (returned by IRB for changes) 55
56 On the Dashboard, click here to view your studies 56
57 Click on the Study that Requires Changes 57
58 Click on the appropriate Submission 58
59 Click here to edit the Submission 59
60 A bubble with the number of comments will display in each section needing changes Clicking on Expand Comments will allow you to read and address the Reviewer s comments 60
61 Changes/information must be added to the questions and/or text boxes themselves, not just in a reply to a comment Click here once you have made the requested changes and select Address 61
62 Once you have addressed all comments, select COMPLETE SUBMISSION to send the submission to the PI to certify 62
63 The PI must certify the submission in order for it to be returned to the IRB 63
64 IRB Still have questions? For questions and problems relating to logon or technical issues, please For questions regarding your submission to the IRB, please 64
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