STREAMLYNE INITIAL GUIDE FOR PRINCIPAL INVESTIGATOR Rev. 10/2018. I. Protocol Application & IRB Certification Tutorial...2

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1 STREAMLYNE INITIAL GUIDE FOR PRINCIPAL INVESTIGATOR Rev. 10/2018 I. Protocol Application & IRB Certification Tutorial...2 II. Logging In (Password)... 2 III. Creating a New Protocol Record / Menu Bar... 3 a. Overview... 4 b. Study Personnel... 6 c. Protocol& Notes... 8 d. Submission & Approval IV. Route Log (Faculty Supervisor / Co-Investigator Approval Confirmation) V. Disapproved Protocol by Faculty Supervisor VI. Protocol Status VII. IRB Timeline VIII. Revising a Returned Protocol IX. Edit Returned Protocol and Create a Cover Letter X. Protocol Approval XI. General Functions Action List All My Protocols Function Recall Protocol Record

2 I. Protocol Application & IRB Certification Tutorial. Important! Before you start the Streamlyne process, please refer to the IRB Website to complete the Protocol Application form and the IRB Certification Tutorial (formerly NIH): 1. PROTOCOL APPLICATION (Exempt, Expedited or Full Board risk level review). a. Review type determination document will help you determine which review type to select. b. Sample expedited protocol: reference tool to accurately complete the initial submission. 2. IRB TUTORIAL CERTIFICATION (Online system Catalog guide provided on the IRBWebsite). All Principal Investigators, (Student/Faculty/Staff) and Co-Investigator (Student/Staff), Co- Investigator (Faculty/Faculty Supervisors are not required to provide certification), must complete the Alliant IRB Tutorial Certification for the Protecting Human Subject Research Participants or other IRB certification tutorial (accepted on case-by-case basis). a. This free tutorial provides training on ethics for working with human subjects as well as explains the background and purpose of the IRB. b. The tutorial satisfies requirements for Alliant International University's Institutional Review Board and research courses. It may not meet requirements of external organizations, including foundations and grant making institutions. It is the responsibility of the investigator to determine the certification requirements of external entities and secure any required certifications. II. Logging In. 1. Access Streamlyne at or through the IRBWebsite 2. Sign in using your Alliant credentials (e.g., jsmith). 3. Lowercase, do not 4. Some systems (e.g., alliant , Moodle, Canvas, etc.) may be currently accessible, but if you 2

3 encounter difficulties with Streamlyne log in process, please reset and update your password through Password Assistance link provided below (Password reset): III. Creating a New Protocol Record. 1. NEW RECORD: Create a new record by following the navigation path: a) Click MAIN MENU b) Go down to IRB c) Go right to IRB Protocol (do not click on word IRB Protocol) d) Click on PLUS SIGN + 2. MENU BAR: Use the menu located in the right to navigate through the application. a) Overview b) Study Personnel c) Permissions (Not used) d) Protocol & Notes e) Submission & Approval 3

4 DOCUMENT OVERVIEW-REQUIRED FIELDS TO SAVE DOCUMENT: Important: You MUST complete the mandatory fields in the Overview tab screen to move to the other tabs. 1. Last Name, First Name: Type your last name, followed by your first name: Ex: Smith, John. 2. Protocol Type: Choose from EXEMPT, EXPEDITED OR FULL BOARD. 3. Protocol Title: Enter the TITLE of your protocol application / study / dissertation. 4. Principal Investigator: Click the MAGNIFYING GLASS next to Alliant User Name. a) Fill in ONE search field (e.g., Last Name: Smith). b) Click SEARCH button. c) Click RETURN VALUE to choose yourself. d) You will be returned to the previous screen and your name will appear in the field. 4

5 5. Department: This field will default to your degree program once you select yourself as the PI. a) If Department is incorrect or blank, click the MAGNIFYING GLASS. b) DO NOT fill in any search criteria in the screen that appears. c) Click SEARCH button to view all departments. d) Click RETURN VALUE to choose your department/degree. e) If you cannot find your department, select the general degree. Once you have completed required fields, SAVE your work by clicking the button. 5

6 Important: If you are a Student you must include a Core Faculty as your Faculty Supervisor. 1. Only the Faculty Supervisor is required. 2. Every person included as a Co-Investigator or Faculty Supervisor will be required to approve the protocol in Streamlyne for each submission process. 3. Add dissertation committee members name in the Notes sections under Protocol & Notes Tab if necessary. ADD CO-INVESTIGATOR OR FACULTY SUPERVISOR: a. Go to STUDY PERSONNEL. b. Click on PROTOCOL PERSONNEL. c. Click the MAGNIFYING GLASS next to Alliant User Name. d. Fill in ONE search field (e.g., Last Name: Smith). e. Click SEARCH button. 6

7 f. Click RETURN VALUE to choose selected name. g. You will be returned to the previous screen and the person s name will appear in the field. h. Select the person s role from the PROTOCOL ROLE drop-down. i. Click ADD button. Repeat these steps for any other personnel. j. Once you have completed required fields, SAVE your work by clicking the button. REMOVE CO-INVESTIGATOR OR FACULTY SUPERVISOR: a) CHECK MARK the box in front of the name. b) Select DELETE SELECTED. 7

8 Important: 1. The IRB recommends you work on your application with your faculty supervisor prior to uploading it into Streamlyne. 2. Upload your application and all appendices incorporated (consent form, measures, approval s, etc.) as ONE MS Word document. 3. Appendices: Measure or other documents in PDF format can be converted to jpeg (copy/paste) added as image or incorporated as screen shot in the appendices. Adobe Acrobat allows you to convert PDFs to Word documents with these steps: o Open a file in Acrobat. o Click on the Export PDF tool in the right pane. o Choose Microsoft Word as your export format, and then choose Word Document. o Click Export. o Name the Word file and save it in a desired location. PROTOCOL: UPLOAD IRB TUTORIAL CERTIFICATION AND PROTOCOL APPLICATION: a) Click the PROTOCOL & NOTES tab. b) Click the PROTOCOL ATTACHMENTS bar. c) Select DOCUMENT TYPE: (e.g. NIH Certificate, Protocol Application, etc.). 8

9 d) Click the BROWSE button to select the document from your computer desktop. e) DESCRIPTION is optional. f) Click ADD. NOTES: 1. Use the NOTES section to enter the names of any members of your dissertation committee or any extra information about your application. a) Be sure to include a NOTE TOPIC and NOTE TEXT. b) Click ADD to the right of the text box to submit the note with your protocol. c) SAVE your work by clicking the button. 9

10 PROCESS SUBMISSION: Click on SUBMISSION & APPROVAL tab. a) b) Click REQUEST AN ACTION bar. c) Select SUBMISSION TYPE (Application for Approval, Response to Required Revision, etc.). d) Select SUBMISSION REVIEW TYPE (The risk level of your protocol). Exempt or Expedited: Streamlyne will prompt you to choose from a list of categories. Choose all the Categories 1 ~ 5 that are applicable to your study Amendment or Renewal: No change in category of review box is for previously received IRB Approval protocol applications only. 10

11 e) Click SUBMIT button to process the protocol. f) A MESSAGE WILL APPEAR AT THE TOP stating your application was successfully submitted. Congratulations! You have successfully submitted your protocol application. Important: If you are a STUDENT, you may want to notify your FACULTY SUPERVISOR that he or she will need to approve your application through Streamlyne before it can be sent for review. IV. Route log Faculty Supervisor/Co-Investigator Approval Confirmation. Check the date and time when the protocol was approved and submitted to the IRB. a) Click SUBMISSION AND APPROVAL. b) Click ROUTE LOG. c) Go to ACTION TAKEN of date and time when protocol was approved. d) Go to PENDING ACTION REQUEST, to check who has not approved the protocol record. 11

12 V. Disapproved Protocol by Faculty Supervisor. This section describes how to EDIT AND RESUBMIT your protocol if your FACULTY SUPERVISOR DISAPPROVES it. 1. You will RECEIVE AN NOTIFICATION alerting you that your protocol was disapproved. 2. In your ACTION LIST, you will see your disapproved protocol with an acknowledge symbol next to it. 3. Click on the ID NUMBER hyperlink to access the protocol. a) Go to the SUBMISSION & APPROVAL tab. b) Click the ACKNOWLEDGE button at the bottom of the screen. c) You will be TAKEN BACK to the Action List page. 1. In your Action List, click the hyperlink next to your protocol to make the appropriate changes. 12

13 a) EDIT requested revisions requested by your Faculty Supervisor. b) RESUBMIT your protocol. c) Go to SUBMISSION & APPROVAL section. d) FOLLOW THE SAME STEPS you used to initially submit your application under PROCESS SUBMISSION. VI. Protocol Status. a) Check the STATUS of your protocol at the top right corner of the screen. b) When the Submission Status Reads SUBMITTED TO COMMITTEE, your application has been sent to a committee member for review. VII. IRB Timeline. 1. IRB cannot fast-track or expedite an application for any reason. 2. Below are estimates of the amount of time you should allow for your application to go through the 13

14 review process. (Note: Reviews may take more or less time than indicated). a) Exempt: 3-5 weeks b) Expedited: 5-7 weeks c) Full Board: 7-10 weeks (Full Board applications may take at least one month for initial review) Important: All reviews take a MINIMUM OF 10 BUSINESS DAYS for a response. a) This time frame applies to initial submissions and all subsequent revisions. b) Once a PI submits an initial protocol he/she can expect a minimum of 10 business days to receive approval or revisions. c) Once a PI submits revisions he/she can expect a minimum of 10 business days to receive another response. VIII. Revising a Returned Protocol. This section explains how to edit a protocol that is returned. 1. IRB Administrator: Follow instructions incorporated in the IRB Committee Member: You will receive two s: An Action List Reminder and a detailed with instructions. a) Click either on the LINK IN THE to access instructions on Action List Reminder. b) The DETAILED will contain link protocol number to access your protocol. 14

15 c) View REVIEW LETTER HERE to access the PDF letter returned with revisions from reviewer. ACCESSING YOUR REVIEW COMMENTS AT A LATER TIME: Though you will receive review comments in an and PDF letter, you may want to access them in Streamlyne at a later time. a) Click on SUBMISSION & APPROVAL tab. b) Click the SUMMARY & HISTORY tab. c) Click the SHOW button to expand the REVIEWS AND ATTACHMENT section. d) Click on the SHOW button to expand the REVIEW COMMENTS section. 15

16 IX. Edit Returned Protocol and Create a Cover Letter. EDIT PROTOCOL APPLICATION: 1. Address the SPECIFIC MINOR REVISIONS or SUBSTANTIVE REVISION. 2. DO NOT use Track Changes. 3. RESPOND to revisions addressed to all the comments in the appropriate section in the original protocol application. 4. HIGHLIGHT IN YELLOW all changes made in the original protocol. a) Select PROTOCOL & NOTES tab. b) Click on PROTOCOL ATTACHMENTS c) REPLACE revised protocol with previously uploaded document. COVER LETTER (New Attachment): 1. Write a COVER LETTER with a point-by-point response, in a Question & Answer format by INCLUDING suggested reviewer comments. 2. Provide a DETAILED explanation and INCLUDE THE EXACT CHANGES made to each revision listed. 3. Action responses such as: Attached as requested or Changed, will NOT be accepted. 4. UPLOAD COVER LETTER. a) Select PROTOCOL & NOTES tab. 16

17 b) Click on PROTOCOL ATTACHMENTS. c) Select DOCUMENT TYPE: Revision Cover Letter. d) Select BROWSE to find created Cover Letter from your computer desktop. e) ADD and SAVE. a) RESUBMIT your protocol. b) Go to SUBMISSION & APPROVAL section. c) FOLLOW THE SAME STEPS you used to initially submit your application under PROCESS SUBMISSION. IMPORTANT: If you are a student, you may want to notify your Faculty Supervisor that he or she will need to approve your application through Streamlyne before it can be sent back for review. X. Protocol Approval. You will receive an notification alerting you that your protocol was approved. 1. The approval letter will be accessible by clicking on the hyperlink provided CLICK HERE TO 17

18 VIEW YOUR APPROVAL LETTER. 2. CORRESPONDENCE NOTES: If applicable, address minor requested revisions addressed at the bottom of the letter. ACCESSING YOUR APPROVAL LETTER AT A LATER TIME Though you will receive your approval letter in an , you may want to access it in Streamlyne at a later time. Select the ALL MY PROTOCOLS Function which will allow you to quickly access your protocols. a) Go to MAIN MENU. b) Drop down to IRB. c) Right down to ALL MY PROTOCOLS. Your protocol will appear below the search box. 18

19 Click EDIT next to the protocol you want to access. a) Go to the SUBMISSION & APPROVAL tab. Open the SUMMARY & HISTORY section. b) Click the SHOW button next to History. c) d) Click the SHOW button next to CORRESPONDENCES. e) Click VIEW to see your letter. XI. General Functions. ACTION LIST 1. Your Action List will be the first screen you see when you log in. 2. It is a list of all items that require your attention. Streamlyne notifies you of pending items in two ways: notifications containing hyperlinks to take you right to the Streamlyne document. Be sure not to click on old notifications. The addition of a new item to your Action List 19

20 The symbols under the Action column have the following meanings: ACKNOWLEDGE: This item requires your acknowledgment that processing is completed. APPROVE: This item requires that you review the details and make a decision to COMPLETE: (Approve, Disapprove, or Reject the document s content). This item requires that you complete one or more sections of the document. ALL MY PROTOCOLS FUNCTION The All My Protocols Function allows you to quickly access all your Active protocols. a) Go to MAIN MENU. b) Drop down to IRB. c) Right down to ALL MY PROTOCOLS. Your protocol will appear below the search box. a) Click EDIT next to the protocol you want to access. b) Your ACTIVE protocols will appear below the search box. 20

21 RECALL PROTOCOL RECORD: If for any reason, you want to make changes to the protocol or need to upload a missing document after your application has been submitted, access the RECALL button after accessing your protocol. 1. Go to All My Protocols Function allows you to quickly access your protocol. a) Go to MAIN MENU. b) Drop down to IRB. c) Right down to ALL MY PROTOCOLS. 2. Your protocols will appear below the search box. Click EDIT next to the protocol you want to recall. 3. Click SUBMISSION & APPROVAL and the RECALL button will be available at the bottom of the screen. 21

22 4. Enter a REASON you want to recall the record and click YES. This process will then take you back to the protocol APPLICATION PROCESS, make all necessary changes and RESUBMIT. 22