STREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS

Transcription

1 STREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS Rev: 01/2017 In This Document Logging In... 1 Creating a New Protocol... 2 Revising a Returned Protocol... 7 Submitting an Amendment or Renewal Application... 8 General Functions... 9 Logging In 1. Access Streamlyne at or through the IRB Website. 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: 1

2 Creating a New Protocol 1. Initiate a new document by following the navigation path: Main Menu IRB IRB Protocol plus sign + 2. You will see this menu bar on the left side of your screen. Use this menu to navigate through the application. Overview Tab Complete the following mandatory fields in the Overview tab. You MUST complete the required fields in this 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. 2

3 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. 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. first name). Click return value to choose yourself. For further instructions, go to Lookup Functions. 4. Title: Enter the title of your protocol / dissertation title. 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 glass 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. 6. Save your work by clicking the Save button. Study Personnel Tab The Study Personnel tab allows you to add additional personnel to your protocol, such as a Co- Investigator or Faculty Supervisor. Note: Only the Faculty Supervisor is required. Students should not include their dissertation committee members as Co-Investigators or Faculty Supervisors. Every person included as a Co-Investigator or Faculty Supervisor will be required to approve the protocol in Streamlyne for each submission. There is an option to add the names in the Notes sections under (see below: Protocol & Notes Tab). 1. Click the Study Personnel tab. 2. To add a Co-Investigator or Faculty Supervisor, type the person s Alliant username ( address without into the search box. Then click anywhere outside the text box and the name will appear below. If you do not know the username, click the magnifying glass to search for the person. 3

4 3. Select the person s role from the Protocol Role drop-down. To add a Faculty Supervisor, select the role as Co-Investigator or Faculty Supervisor. 4. Click the Add button. 5. Repeat these steps for any other personnel. Protocol & Notes Tab Before filling out this section, you should complete your protocol application, found on the IRB Website. Be sure to upload your application and all appendices (consent form, measures, etc.) as ONE MS Word document. 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. Choose a Document Type and click the Browse button to select the document from your computer. The description is optional. 4

5 4. Click Add. 5. If you would like to include any extra information about your application, you may enter it in the Notes section. Use this section to enter the names of any members of your dissertation committee or any other information you want IRB to know. Be sure to include a Note Topic, Note Text, and to click Add to the right of the text box to submit the note with your protocol. Submission & Approval Tab This is the section where you will submit your protocol for review. 1. Click on the Submission & Approval tab. 2. Select the Submission Type and Submission Review Type. 3. 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. 4. Click the Submit button to send the protocol into workflow. If you have designated a Co-PI or Faculty Supervisor, Streamlyne will send your submission for approval prior to sending it to the IRB Administrator. 6. If there are any errors, you will see a red error message at the top of the page. To correct errors, go to the Data Validation section. 7. Click the Show button to expand the Validation Errors subsection. 8. Click the Fix button next to the listed error. 9. Streamlyne will take you to the section of the document where you can correct the error. Repeat for all errors. Once all errors are addressed, click the Submit button. A message will appear on the screen stating your application was successfully submitted. 5

6 Congratulations!!! You have successfully submitted your protocol. 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. Route Log: 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. Protocol Status: 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. 6

7 Disapproved Protocol This section describes how to edit and resubmit your protocol if your 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. Click on the hyperlink to access the protocol. 3. Go to the Submission & Approval tab and click the Acknowledge button at the bottom of the screen. 4. In your Action List, click the hyperlink next to your protocol to make the appropriate changes and resubmit using the steps above. Revising a Returned Protocol Once sent for review, your protocol may be returned to you by the IRB Administrator or an IRB Committee Member for revisions. This section explains how to edit a protocol that is returned for either of these reasons. 1. You will receive an with either a link to a PDF of your revisions letter (if returned with revisions from a reviewer) or an with instructions from the IRB Administrator (you will not see a PDF letter). 2. Click on the link in the to access your protocol. To access the protocol from your Action List, click the hyperlink next to your protocol. 7

8 3. Address the comments in the appropriate areas of your protocol and highlight all revisions. Re-upload your revised protocol in the Protocol & Notes section using the Replace button. 4. As a new attachment, write and attach a cover letter with a detailed point-by-point response to each revision listed. Note: If your protocol was returned by the IRB Administrator, and you did not receive a Substantive or Specific Revisions Letter, this cover letter is not necessary. 5. Resubmit your protocol through the Submission & Approval section following the same steps you used to initially submit your application. You will receive an approval letter via once your protocol receives final approval. Submitting an Amendment or Renewal Application IRB approval is required to amend or renew an already approved protocol. All expedited and full board protocols require annual renewal (exempt protocols do not expire). The process is the same for either of these applications. 1. Click on the Amend or Renew IRB Protocol option in the menu. 2. You will be taken to a list of all your protocols. Choose Perform Action next to the protocol you wish to renew or amend. 8

9 3. You will be taken to the Request an Action section. Click Show next to the option you need. Do not click Notify IRB. 4. IMPORTANT: If your selection is Create Renewal without Amendment, in the summary box, indicate that there are no amendments in your protocol and click the Create button. There is no need to complete, nor upload a renewal request form. Skip steps #6 and #7 and continue to #8 Submission & Approval tab. If your selection is Create Amendment or Create Renewal with Amendment. In the Summary text box, indicate the sections of your protocol in which you will make changes, if any. Follow all steps #5 through #9. 5. Click the Create button Click on the Protocol & Notes tab Utilize the steps outlined above to upload your completed Amendment or Renewal Application with your approved protocol and any appendices as one MS Word document. These applications are on the IRB Website. Return to the Submission & Approval tab. Select the Submission Type and Submission Review Type and click Submit. 9. Correct any errors using the process described in the Submission & Approval section under Creating a New Protocol. 9

10 Congratulations!!! You have successfully submitted your Amendment or Renewal Application. 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. General Functions This section discusses basic functionality that appears throughout the Streamlyne program. These instructions will help you navigate the program more easily. Action List Your Action List will be the first screen you see when you login. 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 Approve Complete This item requires your acknowledgement that processing is complete. This item requires that you review the details and make a decision to Approve, Disapprove, or Reject the document s contents. 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 your protocols. To access this section, go to Main Menu IRB All My Protocols. Your protocols will appear below the search box. 1

11 Lookup Function The Lookup Function allows you to search for a specific item to enter into a field. The most common use of this function is a person lookup, which is the example shown here, though the steps are the same for any type of lookup. 1. To begin the lookup, click on the magnifying glass next to the field you wish to complete. 2. A screen will open in which you may enter search criteria. If you enter no criteria, the search will return all items. 3. Once you find the correct person or entity, click return value next to the name. You will be returned to the previous screen and the person s name will appear in the field. Don t forget to click the Add button to complete the step where necessary. Permissions Tab This tab allows you to grant permission to an individual not listed on your protocol, such as a research assistant. Follow these steps to grant access to a research assistant. 1. Click on the Permissions tab. 10

12 2. To add a user, search for the username 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 permissions. to complete this action. Repeat steps for all additional Accessing Your Approval Letter Though you will receive your approval letter in an , you may want to access it in Streamlyne at a later time. 1. Go to the Submission & Approval tab. 2. Open the Summary & History section. 3. Click the Show button next to History. 4. Click the Show button next to Correspondences. 5. Click View to see your letter. Accessing Your Review Comments 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. 2. Click on the Summary & History section. 3. Click the Show button to expand the Reviews and Attachments section. 4. Click on the Show button to expand the Review Comments section. 11