STREAMLYNE INITIAL GUIDE FOR PRINCIPAL INVESTIGATOR / STUDENT

Transcription

1 Rev: 06/2017 STREAMLYNE INITIAL GUIDE FOR PRINCIPAL INVESTIGATOR / STUDENT In This Document Protocol Application (Exempt and Expedited/Full Board Review)...2 NIH Certificate (Required)... 2 Logging In... 2 Password... 2 Creating a New Protocol... 3 Overview (Document Overview, Required Fields for Saving Document)... 4 Study Personnel (Protocol Personnel)... 6 Protocol& Notes (Protocol Attachments, Notes)... 9 Submission & Approval (Request an Action, Print, Summary & History, Route Log) Route Log (Faculty Supervisor / Co-Investigator approval confirmation) Protocol Status IRB Timeline Recall Protocol Disapproved Protocol Revising a Returned Protocol Accessing Your Review Comments at a later time Edit Returned Protocol...17 Protocol Approval Accessing your Approval Letter at a later time General Functions Action List All My Protocols Function...22 Permission Tab

2 Protocol Application Important! Before you start the Streamlyne process, please refer to the IRB Website to complete the Protocol Application form and the NIH Certificate: 1. PROTOCOL APPLICATION (Exempt, Expedited or Full Board 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. NIH CERTIFICATE a. All students must complete the NIH Protecting Human Subject Research Participants or other IRB certification tutorial (accepted on case-by-case basis). b. The free training tutorial provides training on ethics for working with human subjects as well as explains the background and purpose of the IRB. Logging In 1. Access Streamlyne at or through the IRBWebsite 2. Sign in using your Alliant credentials (lowercase, do not Password reminder: To ensure account security, Alliant International University s password policy requires all users to change their respective passwords every 180 days. Some systems (e.g. alliant , Moodle, Canvas, etc.) may be currently accessible, but if you cannot log in into Streamlyne, there is a need to reset the password to update access to Streamlyne and the rest of the system through the main server. If you encounter difficulties with log in process, please reset your password through Password Assistance link provided below (Password reset): 2

3 Creating a New Protocol Record STREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS Important: If you do not have the navigation path options listed below please click Research Home above the Streamlyne Logo. 1. Initiate a new document by following the navigation path: Main Menu > IRB > IRB Protocol plus sign + 2. You will see the menu bar on the left side of your screen. Use this menu to navigate through the application (Overview, Study Personnel, Protocol & Notes, Submission & Approval). 3

4 Overview Tab STREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS Important: You MUST complete the mandatory fields in the Overview tab screen to move to the other tabs in the protocol. If you try to go to another tab without completing this screen, you will get an error message. 1. Last Name, First Name: Enter your last name followed by your first name: Ex: Smith, John. 2. Protocol Type: Choose from Exempt, Expedited, or Full board. Review Type Determination Document provided in the IRB Website explains the three review types and will help you determine which review type to select and how to proceed. 3. Title: Enter the title of your protocol / dissertation title. 4. Principal Investigator: Click the magnifying glass next to Alliant User Name and search for your name (you only need to fill in ONE search field, e.g. Last Name: Smith). Click return value to choose yourself. You will be returned to the previous screen and the person s name will appear in the field. 4

5 5. Department: This field will default to your department/degree program once you select yourself as the PI. If incorrect or blank, click the magnifying to search for the correct department. Do not fill in any search criteria in the screen that appears. Simply click the Search button to view all departments. Click return value to choose your department/degree. 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 Study Personnel Tab Important: If you are a Student you must include a Core Faculty as your Faculty Supervisor. Every person included as a Co-Investigator or Faculty Supervisor will be required to approve the protocol in Streamlyne for each submission process. 1. The Study Personnel tab allows you to add additional personnel to your protocol, such as a Co- Investigator or Faculty Supervisor. 2. Only the Faculty Supervisor is required. 3. Students should not include all their dissertation committee members as Co-Investigators unless it is essential. 4. There is an option to add dissertation committee members name in the Notes sections under Protocol & Notes Tab. 5. To add a Co-Investigator or Faculty Supervisor, type the person s Alliant username ( address, lowercase, do not into the search box. Then click anywhere outside the text box and the name will appear below. 6

7 6. Select the role as Co-Investigator or Faculty Supervisor. 7. Don t forget to click the Add button to complete the step where necessary. Repeat these steps for any other personnel. 8. If you do not know the username, click the magnifying glass next to Alliant User Name and search for the name (you only need to fill in ONE search field, e.g. Last Name: Smith). 9. Click return value to choose selected name. You will be returned to the previous screen and the person s name will appear in the field 10. Select the person s role from the Protocol Role drop-down. 11. Don t forget to click the Add button to complete the step where necessary. 12. Repeat these steps for any other personnel. 7

8 13. Save your work by clicking the button. 14. If you would like to remove someone from the list, simply check mark the box in front of the name and select Delete Selected. 8

9 Protocol & Notes Tab Important: found on the IRB website. Before filling out this section, you should have complete your protocol application, Be sure to upload your application and all appendices incorporated (consent form, measures, approval s, etc.) as ONE MS Word document. 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. The IRB recommends you work on your application with your faculty supervisor prior to uploading it into Streamlyne. 1. Click the Protocol & Notes tab. 2. Click on each heading to expand the section. 3. Upload your protocol in the Protocol Attachments section. 4. Choose a Document Type: e.g. NIH Certification, Protocol Application, etc. 9

10 5. Click the Browse button to select the document from your computer desktop. The description is optional. 6. Click Add. 7. If you would like to include any extra information about your application, you may enter it in the Notes section. 8. Use this section to enter the names of any members of your dissertation committee or any other information you want IRB to know. 9. Be sure to include a Note Topic and Note Text. 10. Click Add to the right of the text box to submit the note with your protocol. 11. Save your work by clicking the button. 10

11 Submission & Approval Tab STREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS This is the section where you will submit your protocol for review. 1. Click on the Submission & Approval tab. 2. Click Request an Action bar. 3. Select the Submission Type (Application for Approval, Response to Required Revision, etc.). 4. Select Submission Review Type, which is the risk level of your protocol (Exempt, Expedited or Full Board review). 5. If you select Exempt or Expedited, Streamlyne will prompt you to choose from a list of categories. If your protocol does not fit any of these categories, it is possible you are applying under the wrong review type. 6. Choose all the Categories 1 ~ 5 that are applicable to your study. Note: Amendment or Renewal: No change in category of review box is for already received IRB Approval protocol applications only. 7. Click the Submit button to process the protocol. 11

12 8. If you have a designated a Co-Investigator or Faculty Supervisor, Streamlyne will send your submission for approval prior to sending it to the IRB Administrator 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. There is a guide for Faculty Supervisors on the IRB website in the myalliant portal. A message will appear on the screen stating your application was successfully submitted. Congratulations!!! You have successfully submitted your protocol. Route Log (Faculty Supervisor / Co-Investigator approval confirmation): You may check the date and time when the protocol was completed, approved by Co-Investigator or Faculty Supervisor and submitted to the IRB by accessing Route Log. Submission and Approval > Route Log > Action Taken > Pending Action Request 12

13 Protocol Status: STREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS You may check the status of your protocol at the top right corner of the screen. When the Submission Status Reads Submitted to Committee, your application has been sent to a committee member for review. IRB Timeline: IRB cannot fast-track or expedite an application for any reason. Below are estimates of the amount of time you should allow for your application to go through the review process. Note that each time frame is an estimate and reviews may take more or less time than indicated. Exempt: 3-5 weeks Expedited: 5-7 weeks 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. This time frame applies to initial submissions and all subsequent revisions. Once a PI submits an initial protocol he/she can expect a minimum of 10 business days to receive approval or revisions. Once a PI submits revisions he/she can expect a minimum of 10 business days to receive another response. Recall Protocol: 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 to quickly access your protocols. To access this section, go to: Main Menu > IRB > All My Protocols 13

14 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. 4. Enter a reason and click Yes. 5. This process will then take you back to the protocol application process, make all necessary changes and resubmit. 14

15 Disapproved Protocol This section describes how to edit and resubmit your protocol if your Faculty Supervisor disapproves it. You will receive an notification alerting you that your protocol was disapproved. In your Action List, you will see your disapproved protocol with an acknowledge symbol Click on the ID number hyperlink to access the protocol. next to it. Go to the Submission & Approval tab and click the Acknowledge button at the bottom of the screen. You will be taken back to the Action List page. In your Action List, click the hyperlink next to your protocol to make the appropriate changes and resubmit your protocol through the Submission & Approval section following the same steps you used to initially submit your application. 15

16 Revising a Returned Protocol This section explains how to edit a protocol that is returned. 1. Once sent for review, your protocol may be returned to you by the IRB Administrator with instructions incorporated in the If the protocol is returned by the IRB Committee Member for revisions, you will receive two s: An Action List Reminder and a detailed with instructions. You can click either on the link in the to access instructions on Action List Reminder, or The detailed will contain link protocol number to access your protocol or View REVIEW letter here to access the PDF letter returned with revisions from a reviewer. 16

17 Accessing Your Review Comments at a later time STREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS Though you will receive review comments in an and PDF letter, you may want to access them in Streamlyne at a later time. 1. To view the comments, first click on the Submission & Approval tab. Click on the Summary & History section. 3. Click the Show button to expand the Reviews and Attachment section. 4. Click on the Show button to expand the Review Comments section. Edit Returned Protocol 1. Address the specific minor revisions or substantive revision by responding to all the comments in the appropriate section in the original protocol application. DO NOT use Track Changes. 2. Highlight all changes made in the original protocol. 3. If you disagree with the committee's recommendations, you may justify to the review committee why the revisions should not be incorporated in the Cover Letter. 4. Replace your revised and highlighted protocol in the Protocol & Notes section. 17

18 5. Select Browse to find your revised protocol application from your computer desktop and Save. 6. As a new attachment, write a cover letter with a point-by-point response, including suggested reviewer comments with a DETAILED explanation on changes made to each revision listed (Q&A format). 7. Action responses such as: Attached as requested or Changed, will not be accepted. 8. Upload cover letter in the attachments section by selecting: Document Type: Revision Cover Letter. 9. There should not be more than three protocol attachments: NIH Certification (if you are a student), Protocol Application (Revised and highlighted) and Cover Letter. 18

19 10. When you are finished re-submit your protocol through the Submission & Approval section. 11. Follow the same steps you used to initially submit your application to submit the protocol back to the Faculty Supervisor for approval for the IRB Administrator to receive it. 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. 19

20 Protocol Approval STREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS 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 view your approval 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. Important: If you do not have the navigation path options listed below please click Research Home above the Streamlyne Logo. 1. Select the All My Protocols Function which will allow you to quickly access your protocols. To access this section, go to: Main Menu > IRB > All My Protocols 20

21 2. Your protocol will appear below the search box. Click Edit next to the protocol you want to access. 3. Go to the Submission & Approval tab. 4. Open the Summary & History section. 5. Click the Show button next to History. 6. Click the Show button next to Correspondences. 7. Click View to see your letter. General Functions This section discusses basic functionality that appears throughout the Streamlyne program. These instructions will help you navigate the program more easily section explains how to edit a protocol that is returned. 21

22 Action List STREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS Your Action List will be the first screen you see when you log in. It is a list of all items that require your attention. You can always return to your Action List by clicking Research Home at the top of the screen. 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 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 Approve, Disapprove, or Reject the document s content. Complete This item requires that you complete one or more sections of the document. All My Protocols Function 1. The All My Protocols Function allows you to quickly access your protocols. To access this section, go to: Main Menu > IRB > All My Protocols 2. Your protocols will appear below the search box. 22

23 Permissions Tab STREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS This tab allows you to grant permission to an individual not listed on your protocol, such as research assistant. Follow these steps to grant access to a research assistant. 1. Click on the Permission tab. 2. To add a user, search for the user by clicking the magnifying glass to access the lookup. 3. Use the Role field to select the permission for the user. 4. Click the Add button to complete this action. Repeat steps for all additional permission. 23