Revised: February 28, Investigator/Coordinator Guide

Transcription

1 2014 Revised: February 28, 2014

2 Table of Contents Getting Started... 3 Navigational Tips... 4 Adding a New Application (Form 1)... 6 Routing Form Routing for Signatures Workflow Tracking and Signoff

3 Getting Started 1. If you are new to using the UTK IRB, please go to our website at this page!) and review the Frequently Asked Questions page The site contains the basic information you need to know when preparing to submit a research application to the IRB. 2. Open your web browser. Make sure you are using a version of an Internet browser that is supported by imedris. Internet Explorer (however, not compatible with the newest version 10) Google Chrome Firefox Safari 3. Type in the imedris home page web address: and the imedris log-in screen will appear (bookmark this page!). 3

4 4. Log in using your UT Net ID and Password. If you have forgotten your UT Net ID or need to obtain one, go the UTK OIT website at and click "Find Your NetID" on the left-hand navigation. If you are having trouble with your password, you will information on resetting your password under "Password Management" in the same menu. Navigational Tips 1. For security reasons, imedris will log you out after 30 minutes of inactivity. There is a 25-minute warning that will ask if you would like to continue working. If you are not available to click the button, you will lose any unsaved information when the system logs out. Before leaving the computer, make sure you have clicked away from your work. on the top right of the screen before stepping 4

5 2. Once you have logged into imedris, you will be asked if you would like to try the iris Modern Theme. Click Yes, as the Classic Theme is being phased out. The Modern home screen will appear as: 3. The button on the top right of the screen and the home page. logo in the top left corner will return you to the imedris 4. The button on the top right of the screen allows you to exit the imedris system. 5

6 5. The button on the top right of the screen provides links to the IRB member and clinical researcher imedris Guides & Tips and link to the IRB policies. 6. The button on the top right corner of the screen will take you to the previous page. DO NOT USE the back button on your Internet browser when you are in imedris! To navigate back through the application, click on the Sections in the column on the left side of the screen. The Back button will not take you back one page (to the previous section) when you are working on an application. 7. The tab on the left contains your account information including your CITI training, imedris announcements, IRB Confidentiality Agreement, and links to the IRB policies and help files. 8. The tab on the left contains the button to add a new project via the IRB new application form (Form 1):. In addition, under this tab you may access all of your studies that have been registered or created in imedris under. Adding a New Application (Form 1) 1. Under, click. 6

7 2. The first section of the Form 1 (new application) will show as below: 3. After you have answered all of the questions in a section, click to get the next set of questions. 4. When adding personnel to the application in section 3.0, click. 5. Click Find after typing in the last name for the person. 7

8 6. When you have found the person you want to add, click the checkmark beside the name. The screen should then return to your application, and you should see the name in section In questions with charts, you should click Add a New Row to receive text boxes. 8

9 8. Carefully read all of the options in section (418) to ensure you are choosing the correct application for your project. 9. In section (485), if you are uncertain as to whether your study will require full board, expedited, or exempt review, please call the the Office of Research & Engagement at Carefully read section (495). You should only check Yes if you have a multi-site externally sponsored study for which a master protocol has been written by a commercial entity, cooperative study group, non-profit foundation, or NIH grantee. 9

10 11. If you receive this message, you did not answer one of the required fields (questions) in the application. There will be a red exclamation point and red font instructions beneath the required questions that you did not answer. 12. You are not finished with your application until you see the section that says Complete Form or Form Completed. 10

11 13. Once you save the last section (Form Completed), the system will automatically take you to the Routing Form. Routing Form The Routing Form is the package you send to the IRB that contains your application, consent form (if applicable), and other study documents such as surveys, sponsor protocols, investigator s brochures, package inserts, etc. 1. You save through the routing form just as you did the application and the sections populate on the left side of the screen. 11

12 When it prompts you to upload the protocol or consent form, click the or the button. 2. When you click the Add a New Consent button, make sure that the 2 nd option is checked: 3. Each document you upload will need a general title, such as Main Consent Form, Repository Consent Form, Questionnaire, Screening Script, etc. Note that the Version Number will populate automatically; you do not need to change this. Next, you should make the Version Date the exact same date that is shown inside your document! Lastly, if you are uploading a document that is not a consent form, you also must choose the most appropriate category, such as Master Protocol, Investigator s Brochure, Recruitment Materials, etc. 12

13 4. After you have attached the consent form, ensure that it shows up on the consent form page of the routing form. 5. If you have a drug or device study, attach the Investigator s Brochure, package inserts, and/or product literature when prompted. 6. There is also a section for attaching any other project documents, such as surveys, diaries, case report forms, telephone screening scripts, advertisements, etc. 13

14 7. You are not finished with your application until you see the section that says Complete Form or Form Completed. There is a comment box if you need to share any additional information with the IRB (that was not previously asked of you in the application). There are also instructions for signoff and routing at the bottom of this section, so it is a good idea to print this page now. 8. After you save, you will get the screen below, and you can either click Exit Form if you are not ready to route your submission for signatures, or you can click Signoff and Submit if you are ready to route your submission for signatures. 14

15 Routing for Signatures 1. After clicking Signoff and Submit, you will be asked if the submission requires additional routing for approval. 2. Change the answer to Yes because for a Form 1 (new application) submission, the following people must sign off: Principal Investigator (PI) All Co/Sub-Investigators UT Department Chair if PI is a UT student/fellow/resident/employee/faculty member Faculty Advisor if PI is a UT student/fellow/resident/employee/faculty member Hospital Service Chief (for Regional One Health studies) 15

16 3. Once you save, your investigator names will appear. Make sure you check off all of them (for a Form 1 new application) so they are included in the routing for signatures. Note: if some investigator names do not appear, you did not include them in section 3.0 of your application, so you must go back and revise your application. 4. Once you save, the next page shows your UT department chair, and if your study is at Regional One Health, the division chief(s) will show as well. Check off all of them. Note: if a department chair or division chief name does not appear, you did not include him/her in section 3.0 of your application, so you must go back and revise your application. 5. Once you save, you will be asked if you have completed your selection of required signatures. 16

17 6. Make sure you change the answer to Yes and save. (If you do not change the answer to Yes, you will see this warning box after you save:) (If you click on the warning box, you will be able to click on the text below and go back to the routing assignment list, where you can click Yes that you have completed your selection of required signatures.) 17

18 Workflow Tracking and Signoff 1. Once you save after saying Yes, that you have completed your selection of required signatures, you will see the Workflow Tracking page. This page allows you to see where your submission is in the electronic process. You can even see who has signed off by looking at the status column on the left. Below, Margaret and Kim have signed because there is a green check mark beside their names. We are still waiting on Holly, the department chair, to sign off because there is a blue in-process symbol by her name. Note that the department chair/division chief s name will not show up in the tracking until all other persons have signed. In addition, the IRB will NOT receive the submission until all persons, including the department chair/division chief, have signed. 2. If you want to change your routing assignment list, you can click on the Routing Assignment List icon above in the 2 nd column and re-save your list. 18

19 3. If you are the principal investigator or a co-/sub-investigator submitting the routing form, you will be asked to sign off on the submission after you finish the routing assignment list. 4. Click Approve if all of the submission components accurately represent your project, enter your NetID and password, and click Save Signoff. 19

20 5. If you are the coordinator or research staff submitting the routing form, you will then see the screen below. This is your project s home screen. You can click on the green Waiting for Signoffs box to get to the Workflow Tracking page to see where your submission is in the electronic process, who has still not signed off, and whether the IRB has received your submission. 6. Once the IRB has received your submission, the Workflow Tracking page will state this. Note: if all persons have signed (i.e., everyone has a green check mark by his/her name) and you do not see the statement circled below in red, call the IRB immediatelyan electronic error occurred with your submission that must be corrected before the IRB will receive your submission! 7. After the IRB has received your submission, the Outstanding Submission information will no longer be on your study s home page. 20

21 8. You must go to your Submission History to get to the Workflow Tracking page. 9. Then, click the Track Location button. 10. You can then see the status of your submission again, including who was assigned as your analyst in the IRB office. If you have questions about your project, call and ask for this person, as she will be the most familiar with your project. 21

22 11. If you log out of imedris and want to find your project again, you should click My Projects. 12. Find the project you want to view, and Click to open it from the left column. 22