Mentor eirb Researcher User Manual
|
|
- Joleen Cobb
- 5 years ago
- Views:
Transcription
1 Ascension Wisconsin IRB Mentor eirb Researcher User Manual Contents 1 Introduction 1.1 Purpose of this Manual 1.2 User Support 2 Mentor eirb & User Accounts 2.1 About Mentor 2.2 User Roles 2.3 Requesting a User Account 3 General Tips & How-Tos 3.1 Logging in 3.2 Resetting your password 3.3 Navigation and Important Pages 3.4 Designating a Research Coordinator 3.5 Bookmarked Pages 3.6 File Management 3.7 Mentor Messages 4 Submissions 4.1 New Studies 4.2 Continuing or Final Reports 4.3 Amendments 4.4 Reportable Events 4.5 Acknowledgement of Other Materials 4.6 Humanitarian Use Devices 4.7 Request to Defer to NCI CIRB or other Single IRB Reliance Request AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 1 of 22
2 1 Introduction Purpose of this Manual This manual provides essential information that Researchers need to use Mentor eirb. The manual includes a description of the Mentor system and step-by-step explanation of common uses. User Support Mentor System Help To access the Mentor System help text, click on this red question mark icon: You will see this icon and other red color icons or text through Mentor. You can interact with the red items for more information usually you hover over them or click them. Training and Assistance You can contact IRB staff anytime during normal business hours for assistance using Mentor or to schedule a training session. Refer to the IRB website for current contact information. 2 Mentor eirb & User Accounts About Mentor Mentor is an electronic IRB submission and document management system. All submissions to the IRB are submitted using Mentor. Mentor is online and available from any device with internet access. IRB submission forms and templates, including consent form templates, are located on the IRB Info page in Mentor. User Roles The role titles in Mentor are based on the privileges each role has in the system. The role assignment or titles of research personnel in Mentor may be different from that on the Site Delegation of Authority Log or other study documentation. The Mentor Protocol application requires individuals to be identified as one of the following roles: PI: This is the Principal Investigator, as defined above. All approval notices, expiration reminders and other announcements and notifications from Mentor will be sent to the PI. External PI: The designation should be used when the PI is someone external to Ascension Wisconsin with no formal affiliation to the institution. This person would have the research personnel role of Co-I or Sub-I. If added as an External PI in Mentor, they will not be able to access Mentor at all; if they require access, they could request a Mentor user account. Sub-I: The Sub-I role in Mentor should include all Sub-I s and Co-I s as defined above. Persons assigned to this role will have access to view all information in Mentor, but will not receive notifications and are not able to submit and manage protocols. Research Coordinator: Principal investigators may designate one or more other Mentor users as Research Coordinators. Research coordinators are authorized to submit and manage protocols on behalf of their PI. They will also receive all approval notices, expiration reminders and other announcements and notifications from Mentor that are sent to the PI. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 2 of 22
3 Research Associate: Any other study staff should be identified in Mentor as a research associate. Research associates have access to view all information in Mentor, but will not receive notifications and are not able to submit and manage protocols. 2.3 Requesting a User Account You must have a Mentor account before you can access Mentor. Additionally, before staff can be added to a study, they must also have an account. There are two steps in creating an account. STEP 1: Create a New Mentor Account 1. You will need the Form Code: 2. Go to: 3. Complete and submit the form. 4. You will get an to confirm your address and set your password. You can only set up an account online using this method if you use an address from Ascension Wisconsin or common research affiliates ( addresses such as Gmail won't work). If you do not meet these criteria you must contact IRB staff to request an account. STEP 2: Complete your User Profile Once you have a Mentor account, there may be additional steps you need to complete before submitting a project through Mentor. Your User Profile will depend on the kinds of projects that you will submit for review. Involved in the conduct of human subject research CV/ Resume CITI Training Humanitarian Use Devices (HUD) X X Only non-human subject research proposals (like Quality Improvement projects and Emergency or Expanded Access to an investigational product.) Students, residents and fellows conducting research Conflict of Interest Training/ Disclosure X X X Advisor has/will create account X X X X To upload the required documents: 1. Log into Mentor 2. Go to the IRB tab across the top 3. Click on My Training Certificate along the right 4. Use the grey upload button to upload the documents AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 3 of 22
4 3 General Tips & How-Tos 3.1 Logging in You will get an automated from Mentor when your account is established providing instructions. In order to login to the Mentor IRB system the first time, you must set a password. 1. Go to the Mentor website. This link is also found on the IRB public web site. 2. The Institution ID is ASCENSION. Click the box below that field so the Institution ID is filled in every time you visit the Mentor site. 3. The User ID field is your address. This is the you requested when you opened the account. For most Ascension Associates and employed physicians this will be the Ascension address. It will also be the same as the you use for COI SMART. Non- Ascension researchers should enter the address listed on the IRB application form. 4. Enter the password that you chose when you logged in for the first time. 3.2 Resetting your password Go to the Mentor website and choose the "Forgot Password" link just below the login fields. Follow the instructions in the reset your password section above. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 4 of 22
5 3.3 Navigation and Important Pages Mentor Home Page You will be taken to this page when you first log in. Click the IRB tab to get to the IRB forms and other functions. *If there are announcements, they will be displayed here IRB Info Page After clicking the IRB tab, you will be taken to the IRB Info page that lists all IRB submission forms. IRB forms- click the red link to download the document My Protocols Page From this page you can: - Create a new protocol - See all studies that you are listed on and filter by type of study, or your role on the study - Click the study title (red link) to go to the study page - Quickly see the study status, if revisions have been requested and the date the next annual review is due. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 5 of 22
6 Protocol Main Page Each protocol has a main page that lists the general information about the protocol. These fields are completed at the time of initial submission. The main parts of that page are noted below: Protocol title Study team Review type and approval/ expiration dates General study questions Questions depending on the kind of review requested Documents uploaded with the initial review Current approved documents Tabs for ongoing submissions (Cont. Review, Amendments, deviations, etc.) AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 6 of 22
7 3.4 Designating a Research Coordinator Research Coordinators identified in Mentor are able to complete and submit to the IRB on behalf of the PI. However, the PI must designate a coordinator in order for the Research Coordinator field to appear on the PI's protocol summary. Only the names of Research Coordinators who are designated to the PI will be able to selected on that PIs studies. If the PI is unable to do this, contact the IRB office. To designate a Research Coordinator the PI must: 1. Log into Mentor eirb and go to Research Coordinators on the left navigation bar. 2. Click the Designate a New Research Coordinator button. 3. Start typing the coordinator s last name. If the coordinator has a Mentor eirb account, their name will appear. Choose the name and click Designate. If the coordinator does not have a Mentor account yet, they must request one. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 7 of 22
8 4. The Research Coordinator s name will now appear on the PI s Research Coordinator page. *Designated Research Coordinators names are listed here The designated Research Coordinator s name will also show up as an option in the Research Coordinator field when creating a new protocol for that PI. Selecting a Research Coordinator here assigns the coordaintor to a specific study. 3.5 Bookmarked Pages The Mentor Home page includes a My Bookmarks link so that you can have quick access to pages that you commonly use. To bookmark a page, you can click on this red B icon at the top right corner of each page: AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 8 of 22
9 3.6 File Management Before any submission is approved by the IRB, the PI or coordinator are able to click on the red page icon next to the file name to edit, replace or delete the document. To do this: 1. Navigate to the submission in Mentor. 2. Left click on the red page icon that is to the left of the file name link. 3. Choose the option. Edit= rename or change file type Replace= submit a new version of a document already uploaded to Mentor, you should replace the file NOT upload a second one Versions= see all uploaded versions Delete= remove the document from Mentor 4. Follow the instructions on each step to complete the selection. 3.7 Mentor Messages The study team, IRB staff and IRB members can all send messages through Mentor. There is a Messages link at the top right corner of every submission section. On the Message page, you will be able to create a new massage, view and respond to any past messages. When a new message is sent, the recipient receives the message via their account. You can respond via , and all messages are stored in the appropriate section in Mentor for documentation. However, you CANNOT include attachments to Mentor messages, they are not sent. You must upload any documents directly into Mentor. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 9 of 22
10 4 Submissions 4.1 New Study Creating a new protocol in Mentor 1. After logging into Mentor, all of the IRB forms are located on the IRB info page. 2. Make sure to have the materials completed as outlined in IRB Submission Guide for Expedited or Full IRB Review or Exempt studies. Go to the My Protocols page and click on the Create New Protocol button. 3. A Protocol Summary page will open. Complete the questions. a. Research Personnel Researchers must have a Mentor eirb account in order to be added to a study. To request an account go to the Mentor eirb page on the IRB website. Once a Mentor account is set up, you can type last name of the individual and Mentor will populate the field. i. Principal Investigator: Choose the PI name from the drop-down menu. ii. Research Coordinator: If the PI has designated research coordinators, a Research Coordinator field will appear. Choose the Research Coordinator s name from the drop-down menu. The Research Coordinator will be copied on all eirb correspondence sent to the PI. Instructions for designating a Coordinator are on the IRB website. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 10 of 22
11 iii. Sub-I: Type the first few letters of the individual s last name. Choose the name from the list and click Add. These people will have view only privileges. iv. External PIs: Do not add research collaborators at other sites unless they are engaged in the conduct of the research at the institution. If you have a question about engagement contact the IRB staff at IRB@ascension.org or v. Research Associate: Type the first few letters of the individual s last name. Choose the name from the list and click Add. These people will have view only privileges. b. Protocol title Enter the protocol title. c. Start and End dates Enter the anticipated Start and End dates; start date is required. d. Sponsor information Select the Sponsor Funding type and, if appropriate, enter the study Sponsor/Funding agency and Sponsor or grant study ID. e. Review Type Different questions appear based on the review type you select. i. Full Review: Studies greater than minimal risk ii. Exemption Requested: Human subject research that meets the an exemption category or projects that are not research or do not include human subjects iii. Expedited Review Requested: Studies that are no greater than minimal risk iv. Delegate to and External IRB: Studies requesting another IRB complete the review v. Humanitarian Use Device Request: HUD protocols vi. Emergency Use: Emergency use of an investigational product f. Complete review type specific questions Different questions appear based on the review type you select. g. Upload the Protocol and Main Consent form- you can upload other documents later h. Message If desired, you can send a message to the IRB staff/chair i. Save the Completed Protocol Summary. Click Save when the summary is complete. After saving, an Upload Documents button will appear on the top of the protocol summary. 4. Once saved, you will then be taken to the protocol main page, where you can upload any additional documents. Click on the Upload Docs button at the top of the page. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 11 of 22
12 In Upload Documents pop up, choose a file type from the drop down menu (IRB application, questionnaire, advertisement, additional consent, etc.). Repeat this to attach and save all applicable items. 5. The uploaded documents will automatically appear at the bottom of the protocol summary under a header that matchers the chosen file type name. 6. Your submission IS NOT complete unless you click the Submit Protocol for Review button at the top of the main protocol page. 7. Once you click this to submit the protocol, the IRB staff is notified of the submission and will contact you with any questions. If the IRB requests modifications AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 12 of 22
13 The PI and Research Coordinator will receive an notification if there are questions about your application or revision requests. Follow the steps below to submit revised documents. 1. Log into Mentor and go to the My Protocols page and click on the study title. This takes you to the Protocol Summary page. 2. All of the documents uploaded for the new study are towards the bottom of the page. 3. To replace a document with a revised version, first make sure the revised version has been saved to your PC. Then click on the icon next to the current document, and choose Replace. IRB staff will receive notice that a revised document has been submitted. Follow the steps below to submit additional documents 1. Log into Mentor and go to the My Protocols page and click on the study title. This takes you to the Protocol Summary page. 2. There are gray buttons on top of the Protocol Summary page. To upload a new document, click the Upload Docs button. 3. Choose the file type that best describes the document. Click Browse to add the file and Save to notify IRB staff that a new document has been submitted. 4. The document will appear at the bottom of the protocol summary under a header that matchers the chosen file type name. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 13 of 22
14 4.2 Continuing or Final Reports 1. Go to the Mentor eirb Info Page download the current Continuing or Final report form. Complete the form and gather other necessary documents indicated in the form. Save all documents as separate electronic files on your computer. 2. When you are ready to submit the continuing or final report, click on "My Protocols" and choose the study. Scroll down to the bottom of the page and click on the "Cont. Reviews" tab. 3. The first item listed should be the report with the Status "Due". Click on the icon, select "Edit". AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 14 of 22
15 4. On the Cont. Review page, indicate the current enrollment status of the study and upload any related documents. You can also enter a note for the IRB staff. Click Submit Report. 5. Your submission is complete, and an IRB staff member will contact you with any questions. Continuing or Final Report IRB revision requests The PI and Research Coordinator will receive an notification if there are questions or revision requests. To submit new or revised documents in the Cont. Review workspace: 1. Locate the study on the My Protocols page and click on the study title. This takes you to the Protocol Summary page. 2. Scroll down to the bottom of the page and click on the Cont. Review tab. Locate the report you are working on (most recent will be on the top). 3. Left click the icon and choose Upload or Replace. Upload the new or revised document(s). Make sure the document is saved with the title you want to display in Mentor eirb. IRB Staff will receive notice that a new/revised document has been submitted. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 15 of 22
16 4.3 Amendments 1. Go to the Mentor eirb Info Page download the current Amendment form. Complete the form and gather other necessary documents indicated in the form. Save all documents as separate electronic files on your computer. 2. When you are ready to submit the Amendment, click on "My Protocols" and choose the study. Scroll down to the bottom of the page and click on the "Amendments" tab, then click the Upload New Amendment. 3. On the Amendment page, upload the completed amendment form and any related documents. You can also enter a note for the IRB staff. Click "Save" to submit. 4. Your submission is complete, and an IRB staff member will contact you with any questions. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 16 of 22
17 Amendment IRB revision requests The PI and Research Coordinator will receive an notification if there are questions or revision requests. To submit new or revised documents in the Amendment workspace: 1. Locate the study on the My Protocols page and click on the study title. This takes you to the Protocol Summary page. 2. Scroll down to the bottom of the page and click on the Amendments tab. Locate the report you are working on (most recent will be on the top). 3. Left click the icon and choose Upload or Replace. Upload the new or revised document(s). Make sure the document is saved with the title you want to display in Mentor eirb. IRB Staff will receive notice that a new/revised document has been submitted. IRB revision requests 4.4 Reportable Events 1. Go to the Mentor IRB info page and download and complete the appropriate form. Save the form and any supporting documents as separate electronic files on your computer. 2. When you re ready to submit the Unanticipated Problem Report, Significant Deviation/Noncompliance Report, or Safety Update (new information from Sponsor, FDA, or DSMB), go to My Protocols and click on the title of the study. Scroll down to the bottom of the page and click the applicable reportable event tab (Unanticipated Problem, Deviation, or Safety Update). Then, use the button to create a new submission. 3. A report information box will open. Attach the report form and check boxes relevant to the submission. Click Save to submit the report. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 17 of 22
18 4. To upload additional document, go to the submission and click on the icon to upload additional documents (revised IB, IND safety report, DSMB report, etc.). 5. Your submission is complete, and an IRB staff member will contact you with any questions. 4.5 Acknowledgement of Other Materials 1. If the study team or study Sponsor want to inform the IRB about something that does not meet the criteria of other submission, you can use the Administrative Review section. Go to "My Protocols" and click on the title of the study. Scroll down to the bottom of the page to the Administrative Review tab, and click New Item AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 18 of 22
19 2. On the Administrative review page, upload the file and enter a brief description. Then, click Save. 3. To upload additional document, go to the submission and click on the icon to upload additional documents related to the administrative review. 4.6 Humanitarian Use Devices 1. Go to the Mentor IRB info page and download and complete the HUD form. Save the form and any supporting documents as separate electronic files on your computer. 2. After completing and organizing materials as outlined in the HUD Instructions & Application Form, you are ready to submit the study in Mentor eirb. Go to the My Protocols page and click the Create New Protocol button. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 19 of 22
20 3. A Protocol Summary page will open. Answer the Protocol Summary questions. Some specific guidance is provided here. a. Adding Physicians to a HUD: Physicians must have a Mentor eirb account in order to be added to a new HUD protocol. b. Review Type: Choose HUD c. Upload HUD product brochure and Patient Information Booklet (or consent if applicable): These documents can be uploaded at the bottom of the survey. Other documents can be uploaded later. Click "Save" when the survey is complete. 4. Click the Upload Documents Button. In Upload Documents, choose a file type from the drop down menu and attach all applicable items. The uploaded documents will automatically appear at the bottom of the Protocol Summary. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 20 of 22
21 5. Your submission IS NOT complete unless you click the Submit Protocol for Review button at the top of the main protocol page. 6. Once you click this to submit the protocol, the IRB staff is notified of the submission and will contact you with any questions. Humanitarian Use Device Continuing Review 1. Locate the HUD Continuing Report form on the Mentor Info Page. 2. After completing and organizing materials as outlined in the HUD Continuing Report Form, follow steps for the standard Continuing or Final Report submission. 4.7 Request to Defer to NCI CIRB or other Single IRB Reliance Request 1. Go to the Mentor IRB info page and download and complete the appropriate form. Save the form and any supporting documents as separate electronic files on your computer. 2. Follow the instructions for a submitting a New Study, with the special considerations below. 3. If you are requesting to rely on an external IRB (including NCI CIRB) select the review type Delegate to an External IRB. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 21 of 22
22 4. If you are requesting for our IRB to be the single IRB of record, select the appropriate review type and make sure to complete the following question during the submission. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 22 of 22
eirb Electronic Institutional Review Board User Guide For more information contact: Research Administration (803)
eirb Electronic Institutional Review Board User Guide For more information contact: Research Administration (803) 434 4899 Developed August 2008 by Research Development University of South Carolina 1 Introduction
More informationera(infoed) Electronic Submission Instructions and Tips: Initial Application
era(infoed) Electronic Submission Instructions and Tips: Initial Application This instructional document introduces users to submitting NEW research protocols electronically through the era(infoed) system.
More informationIRBNet User Manual. University of Denver Human Research Protection Program (HRPP) Institutional Review Board (IRB)
University of Denver Human Research Protection Program (HRPP) Institutional Review Board (IRB) IRBNet User Manual Office of Research Integrity and Education Mary Reed Building 222 INTRODUCTION The Office
More informationKuali Research User Guide: Create an IRB Protocol
Kuali Research User Guide: Create an IRB Protocol Version.0: November 06 Purpose: To create an IRB Protocol document to be used for tracking new Human Subjects Research requests. Trigger / Timing / Frequency:
More informationELECTRONIC RESEARCH STUDY APPLICATION (ERSA) INITIAL APPLICATION GUIDEBOOK. (Version date 03/03/2006)
ELECTRONIC RESEARCH STUDY APPLICATION (ERSA) INITIAL APPLICATION GUIDEBOOK (Version date 03/03/2006) Table of Contents ERSA Home Page and Login 3 CRC Desktop 4 Creating a: New Study Application 5 Amendment
More informationNew Protocol - expedited & full board
New Protocol - expedited & full board training guide 2015, The Trustees of Indiana University KC IRB Training Guide: New Protocol - Expedited & Full Board 1 table of contents Table of Contents 2 table
More informationrenew & Amend A Protocol training guide
renew & Amend A Protocol training guide 2015, The Trustees of Indiana University 1 table of contents Table of Contents 2 table of contents 3 About this guide 4 login 5 Before You Begin Hyperlinks The Table
More informationUNIVERSITY OF NORTH FLORIDA. Institutional Review Board (IRB) Guide to IRBNet:
UNIVERSITY OF NORTH FLORIDA Institutional Review Board (IRB) Guide to IRBNet: Version 2 11-15-2013 Table of Contents i Introduction 2 IRBNet User Registration 2 IRBNet ID Number 2 Training and Credentials
More informationReviewers Guide on Clinical Trials
Reviewers Guide on Clinical Trials Office of Research Integrity & Compliance Version 2 Updated: June 26, 2017 This document is meant to help board members conduct reviews for Full Board: Clinical Trial
More informationDrexel University. Page 1 of 48. Version November agf
Drexel University Page 1 of 48 TABLE OF CONTENTS Getting Started. 3 Creating a New Protocol.. 4 General Information... 7 Organization Information... 9 Investigators/Study Personnel.. 10 Correspondents
More informationLast revised: September 30, e-protocol User Guide 1
e-protocol User Guide Last revised: September 30, 2015 e-protocol User Guide 1 e-protocol is an electronic system for submitting and monitoring the status of Institutional Review Board (IRB) submissions.
More informationUVMClick IRB Study Submission Guide
UVMClick IRB Study Submission Guide September 2018 Table of Contents How to Login 3 How to Create a New Study 4 Find More Information 5 How to Edit a Study 6 Check the Study for Errors 7 Submit the Study
More informationIntroduction to webirb
Introduction to webirb Training Course for Investigators and Study Staff V: 01.24.13 0 You will learn to 1. Navigate webirb 2. Create a new Study application 3. Respond to IRB Requests 4. Create an Amendment
More informationDrexel University. Version March Page 1 of 58 Version 01 March 2017 agf
Drexel University Version March 2017 Page 1 of 58 TABLE OF CONTENTS Getting Started 3 Connecting through the VPN.. 4 Electronic Questionnaires and Applications...10 Welcome to eirb 11 Creating a New Protocol.13
More informationOnline Reliance System FAQs
Online Reliance System FAQs Table of Contents Online Reliance System FAQs... 1 When should the Online Reliance System be used?...3 Who can use the Online Reliance System?...3 Do I have to use the Online
More informationVersion GENESIS HEALTH SYSTEM. Institutional Review Board (IRB) IRBNet User s Guide
Version 1 7-1-2012 GENESIS HEALTH SYSTEM Institutional Review Board (IRB) IRBNet User s Guide G E N E S I S H E A L T H S Y S T E M I N S T I T U T I O N A L R E V I E W B O A R D IRBNet User s Guide Genesis
More informationeirb User Manual for Research Staff
eirb User Manual for Research Staff Version 4 1 10.2016 Table of Contents eirb Access... 3 Log-in to eirb... 4 Overview of the eirb Submission and Review Process... 7 Create a New Application and Specify
More informationNEW PROTOCOL - HUMANITARIAN USE DEVICE (HUD) TRAINING GUIDE
NEW PROTOCOL - HUMANITARIAN USE DEVICE (HUD) TRAINING GUIDE 2014, The Trustees of Indiana University KC IRB Training Guide: New Protocol Humanitarian Use Device (HUD) 1 Table of Contents Table of Contents
More informationPCORI Online: Awardee User Guide Research Awards
PCORI Online: Awardee User Guide Research Awards Updated as of 1/31/18 1 Table of Contents Section 1: Introduction to PCORI Online... 3 1.1 Getting Started - Tips for Using PCORI Online... 4 1.2 Logging
More informationFAQs. Q What is the status of my study application?
FQs Q What is the status of my study application? One of the best things about the eirb system is the transparency regarding the status of your study at any point through the application process. You can
More informationKuali Research User Guide: Create a Protocol Amendment, Renewal or Event
Kuali Research User Guide: Create a Protocol Amendment, Renewal or Event Version.0: November 06 Purpose: To create an amendment, renewal or event on an existing IRB Protocol document. Trigger / Timing
More informationNova Southeastern University IRBManager User Manual IRBMANAGER USER MANUAL
IRBMANAGER USER MANUAL Contents 1. What is IRBManager?...1 2. IRBManager User Accounts/Login...1 a. Creating an IRBManager Account...1 b. Logging into IRBManager...2 c. Forgot Password...2 d. Locked Out
More informationQuestions and Answers. Converting Existing Protocols into CHeRP IRB
Questions and Answers Converting Existing Protocols into CHeRP IRB Questions: (hold ctrl and click on the question to jump directly to that answer) 1. Do I need to convert my existing protocol applications
More informationSTUDY ASSISTANT. Adding a New Study & Submitting to the Review Board. Version 10.03
STUDY ASSISTANT Adding a New Study & Submitting to the Review Board Version 10.03 Contents Introduction... 3 Add a Study... 3 Selecting an Application... 3 1.0 General Information... 3 2.0 Add Department(s)...
More informationHuman Subjects Development Guide
Research Integrity & Compliance Institutional Review Board Human Subjects Development Guide ERA Version 15, Nov. 2016 Table of Contents Logging In... 3 Adding a Delegate... 4 Viewing Items as a Delegate...
More informationARC IRB Chair s Manual
ARC IRB Chair s Manual This guide serves to aid an IRB Chair in becoming familiar with the basic functions of the ARC system and how to review and approve an application. ARC IRB Chairs Manual Page 2 Table
More informationOnce you have created a Project, you must submit the Project s first Package to the ORA.
CREATING, SIGNING, AND SUBMITTING PACKAGE #1 Once you have created a Project, you must submit the Project s first Package to the ORA. CREATE PACKAGE #1 1. Go to the Designer page. This is where an IRB
More informationCOEUS LITE IRB COEUS 4.5.1_P3 USER GUIDE
COEUS LITE IRB COEUS 4.5.1_P3 USER GUIDE Version: August 24, 2016 1 TABLE OF CONTENTS A note about this guide... 4 Getting access to Coeus Lite... 4 Preparing to enter a protocol... 4 Getting Started:
More informationNAU New Project Submission. Guidance for creating a new project
NAU New Project Submission Guidance for creating a new project Go to IRBNet Website address: https://www.irbnet.org/release/index.html Login to your account Enter your Username and Password and select
More informationSTREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS
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...
More informationOffice of Human Research
Office of Human Research JeffTrial End-User Training Document Regulatory Coordinator Training for Non-Oncology personnel Office of Human Research 8/16/2013 Ver. 1.0 Contents The REG Role: Completing Basic
More informationWITH MODIFICATIONS ), S, PHONE NUMBERS OR OTHER FORMS, PLEASE VISIT THE IRB S WEBSITE AT:
Modification Request Dominican College Institutional Review Board (IRB) IRB #: Date Received: IRB Approval Name & Signature: FOR MORE IRB INSTRUCTIONS, APPLICATIONS (including the RENEWAL FORM that should
More informationYou may also scroll through the Table of Contents and click on the topic or question of interest.
We have posted our IRB process related FAQs in a searchable PDF format. You may search by using the CTRL/F key combination. Just type the search word in the box that appears. You may also scroll through
More informationMy Research, Human Protocols (MRHP) PI User Guide October 2017
My Research, Human Protocols (MRHP) PI User Guide October 2017 October, 2017 Page 1 of 22 Contents System Requirements... 3 Browsers... 3 Pop-ups... 3 Chrome... 3 Internet Explorer... 4 Firefox... 4 Safari...
More information***** ***** June
SLU eirb Investigator Guide Saint Louis University ***** eirb Investigator Submitter Guide ***** Institutional Review Board June 2011 http://eirb.slu.edu Institutional Review Board Saint Louis University
More informationInformation Sheet for Scientific Approvers
1 Information Sheet for Scientific Approvers This document will provide you with the basic instructions for your role as a scientific approver in OSIRIS. All listed approvers have been designated by their
More informationNEW PROTOCOL - REQUEST TO DEFER IRB REVIEW
NEW PROTOCOL - REQUEST TO DEFER IRB REVIEW TRAINING GUIDE 2014, The Trustees of Indiana University KC IRB Training Guide: New Protocol - Request to Defer IRB Review 1 Table of Contents Table of Contents
More informationInstitutional Review Board (IRB)
IRBNet User s Instructions for On-line Submission of Research Protocols to the Institutional Review Board (IRB) www.irbnet.org If you have any questions regarding the submission of an IRB protocol contact:
More informationBuck-IRB Amendment User Guide
Office of Research Buck-IRB Amendment User Guide Office of Responsible Research Practices 1960 Kenny Road, Columbus, OH 43210-1016 Institutional Review Board General Guidance for Amendments: The Start
More informationClick. IRB Study Submission Guide
Click IRB Study Submission Guide October 2016 Table of Contents Logging In... 3 Creating a New Study... 4 Finding More Information... 5 Editing a Study... 5 Checking the Study for Errors... 6 Submitting
More informationInstitutional Review Board (IRB)
IRBNet User s Instructions for On-line Submission of Research Protocols to the Institutional Review Board (IRB) www.irbnet.org If you have any questions regarding the submission of an IRB protocol, contact:
More informationChapter 10: Regulatory Documentation
Table of Contents Chapter 10: Regulatory Documentation... 10-1 10.1 Regulatory Requirements:... 10-1 10.2 Ongoing Regulatory Documents:... 10-4 10.3 After study completion or termination of the trial...
More informationHow Does the PI make Pre Review ICF Changes?
How Does the PI make Pre Review ICF Changes? 1 You, as PI of a study, have received notification from the IRB that Changes [are] required by IRB Staff. These changes include a request for a revision of
More informationNAU IRBNet Application
NAU IRBNet Application Guidance for NAU Research Application Revised 17-0202 Go to IRBNet Website address: irbnet.org/release/index.html Login to your account - Enter your Username and Password and select
More informationAmend A Protocol training guide
Amend A Protocol training guide 2015, The Trustees of Indiana University 1 table of contents Table of Contents 2 table of contents 3 About this guide 4 login 5 Before you Begin Hyperlinks The Table of
More informationThe most current protocol information should be entered. This includes incorporation of all past amendments and modifications.
Georgetown University Institutional Review Board Frequently Asked Questions (FAQs) about eric 1. What is eric? eric stands for Electronic Research and Institutional Compliance. This is an on-line IRB application
More informationeirb Training Investigators/Research Coordinators Topics Covered:
eirb Training Investigators/Research Coordinators Topics Covered: 1. Home Page 2. My IRB Protocols 3. Completing New Protocols 4. Amendments & Continuing Reviews 5. Submitting a Protocol 6. Certifying
More informationirb.unm.edu
IRBNet Submission Instructions The purpose of this document is to provide IRBNet submission instructions for UNM researchers using IRBNet. Please contact the Office of the IRB for assistance: irb.unm.edu
More informationeprmc User Manual For Investigators and Research Staff
eprmc User Manual For Investigators and Research Staff Table of Contents How to Get an Account... 3 Logging In... 3 Overview of the eprmc Database... 4 Searching for a Protocol... 5 Adding a New Protocol...
More informationProtocol Management System (PMS) Investigator User Guide. Harris Health System Administrative Approval
Protocol Management System (PMS) Investigator User Guide Harris Health System Administrative Approval November 2013 eprotocol - Investigator User Guide 2 Table of Contents 1. INTRODUCTION 3 2. STARTING
More informationBOULDER IRB era InfoEd Continuing Review
BOULDER IRB era InfoEd Continuing Review Last Update: 2017/11/30 Preface: This guide explains how to submit a continuing review for a previously approved expedited or full board study that is nearing expiration.
More informationOffice of Research Integrity / Office of Sponsored Projects IACUC PROTOCOL SUBMISSION GUIDE
Office of Research Integrity / Office of Sponsored Projects IACUC PROTOCOL SUBMISSION GUIDE Coeus Lite 4.5.1.Px Document Version 3 Updated May 2016 Table of Contents ABOUT COEUS... 3 o About the Coeus
More informationIRBManager Quick Start Guide AMENDMENT SUBMISSION - CHANGE IN PERSONNEL
Page 1 of 12 IRBManager Quick Start Guide AMENDMENT SUBMISSION - CHANGE IN PERSONNEL NOTE: This Quick Start Guide provides instructions for removing and/or adding personnel, other than the Principal Investigator,
More informationIRB News : Addition of a new application type for submitting reliance agreements
In alignment with the NIH mandate for single IRB review that goes into effect in January 2018, HSERA is being updated to include a new reliance agreement specific application. This abbreviated online form
More informationNew Protocol - NoN-humaN subjects research training guide
New Protocol - NoN-humaN subjects research training guide 2015, The Trustees of Indiana University KC IRB Training Guide: New Protocol - Non-Human Subjects Research 1 table of contents Table of Contents
More informationIRBNet User Manual IACUC
IRBNet User Manual IACUC Version 5/29/2012 1 User Manual This user manual is designed to assist in the use of IRBNet. You will find assistance in registration, submission, continuing review, amendments
More informationIRBManager Quick Start Guide INITIAL APPLICATION - OVERVIEW
Page 1 of 16 GENERAL INFORMATION IRBManager Quick Start Guide INITIAL APPLICATION - OVERVIEW Initial Application Types: The IRBManager initial application form (xform) is available for specific types of
More informationUniversity of the Sciences. IRBNet User s Guide
University of the Sciences IRBNet User s Guide Instructions for On-line Submission of Research Protocols to the Research Committees - IRB, IACUC or IBC. www.irbnet.org If you have any questions regarding
More informationCoeus Extension IRB Administrative Process Grant Exemption/Expedited Approval (Initial Protocol or Amendment)
Coeus Extension IRB Administrative Process Grant Exemption/Expedited Approval (Initial Protocol or Amendment) Complete the following steps only when ALL Reviewers have indicated Grant Exemption AND there
More informationRevised: February 28, Investigator/Coordinator Guide
2014 Revised: February 28, 2014 Table of Contents Getting Started... 3 Navigational Tips... 4 Adding a New Application (Form 1)... 6 Routing Form... 11 Routing for Signatures... 15 Workflow Tracking and
More informationSTREAMLYNE INITIAL GUIDE FOR PRINCIPAL INVESTIGATOR Rev. 10/2018. I. Protocol Application & IRB Certification Tutorial...2
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...
More informationSTREAMLYNE INITIAL GUIDE FOR PRINCIPAL INVESTIGATOR / STUDENT
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...
More informationOffice of Human Research
Office of Human Research JeffTrial OHR Training Document OHR Workflow and Data Entry Office of Human Research 8/16/2013 Ver. 1.0 Table of Contents OHR and JeffTrial... 2 JeffTrial Workflow... 2 Workflow
More informationSUBMITTING A NEW IBC PROJECT APPLICATION (INITIAL)
SUBMITTING A After you have established and activated your username and password, you can begin to create an IBC application in IRBNet. To start building a new IBC application, you must first CREATE A
More informationGeneral Guidance for Maintaining a Regulatory Binder
General Guidance for Maintaining a Regulatory Binder Study documentation should be well organized, providing a complete and thorough history from protocol development to study completion. Maintaining a
More informationANNUAL PROGRESS REPORT SUBMISSIONS
SUBMISSIONS The submission of an annual report of an open study requires the creation of a subsequent PACKAGE in a project. As part of the DU IACUC post-approval monitoring program, all IACUC-approved
More information- Direct your browser to This is the homepage for the IRB application.
I. Logging on/setting up an account. - Direct your browser to http://irb.kean.edu. This is the homepage for the IRB application. - First time applicants will have to create a new account. Click on the
More informationHow to Submit a New UIW IRB Application
How to Submit a New UIW IRB Application Step Log In Visit https://uiw.forms.ethicalreviewmanager.com/ click on at the top right corner of the page. New Users: Click on New User Fill in the applicable information
More informationEthical Review Manager. Applicant User Guide
Ethical Review Manager Applicant User Guide Last Updated: June 2017 Introduction The Ethical Review Manager (ERM) System has been designed to enable applications for ethical approval to conduct research
More informationeirb Training Georgia Washington Anne DiSorbo
eirb Training Georgia Washington Anne DiSorbo 1 Agenda IRB Overview Navigator Overview Insight Overview Navigating Insight Reading Workflow History 2 Agenda Case #1: Submitting a New Application Case #2:
More informationFIELDS REQUIRED TO SAVE A PROTOCOL
Human Subject Research Protocols If conducting human subject research, a protocol must be submitted in WVU+kc to the WVU Institutional Review Board for review. Click on the Create IRB Protocol link located
More informationNEW PROTOCOL - NON-HUMAN SUBJECTS RESEARCH TRAINING GUIDE
NEW PROTOCOL - NON-HUMAN SUBJECTS RESEARCH TRAINING GUIDE 2014, The Trustees of Indiana University KC IRB Training Guide: New Protocol - Non-Human Subjects Research 1 Table of Contents Table of Contents
More informationretrieving study documents training guide
retrieving study documents training guide 2015, The Trustees of Indiana University 1 table of contents Table of Contents 2 table of contents 3 about this document 4 retrieving study documents 5 current
More informationBOULDER IRB era InfoEd Amendments
BOULDER IRB era InfoEd Amendments Last Update: 2017/12/06 Preface: This guide explains how to submit an Amendment to modify an approved study. If you already have a submission pending review do not submit
More informationRomeo. How to Apply for a Faculty Conference Travel Grant
Romeo How to Apply for a Faculty Conference Travel Grant Please note: Romeo is compatible with Internet Explorer, Firefox, Edge, Google Chrome and Safari. If you have any problems or questions, please
More informationNew Protocol - emergency use training guide
New Protocol - emergency use training guide 2015, The Trustees of Indiana University KC IRB Training Guide: New Protocol - Emergency Use 1 table of contents Table of Contents 2 table of contents 3 about
More informationUniversity of North Florida
Last edited by: Kayla Champaigne Last edited on: December 5, 2012 University of North Florida Institutional Review Board IRB Protocol Please note, this is a sample of the North Florida - IRB Protocol output.
More informationThe IACUC is charged with the responsibility of ensuring that the Animal Welfare Act policies and procedures are followed.
Protis is an online application system in support of research activities that require approval by the Institutional Animal Care and Use Committee (IACUC) or the Institutional Review Board (IRB). The IACUC
More informationGuide for Researchers: Online Human Ethics Application Form
Guide for Researchers: Online Human Ethics Application Form What is Quest Quest is our comprehensive research management system used to administer and support research activity at Victoria University.
More informationWeill Research Gateway
Table of Contents The - What is the? - Logging In to WRG - The WRG Homepage Conflicts of Interest - What are Conflicts of Interest? - Submitting your Conflicts Survey - Submitting a Travel Disclosure -
More informationDocumentation for Non-Medical Research Ethics Board Researchers Full Board and Delegated Board Review
Documentation for Non-Medical Research Ethics Board Researchers Full Board and Delegated Board Review July 23, 2013 Office of Research Ethics If you run into any difficulties or have questions about Romeo,
More informationTable of Contents. 1. Background Logging In Account Setup Requests Submissions Discussions...
Trust Safety: PwC Connect Tool Upload Release: Final Updated November 2018 Table of Contents 1. Background... 3 2. Logging In... 4 3. Account Setup... 8 3. Requests... 9 4. Submissions... 10 5. Discussions...
More informationReference Card for ORSP
Reference Card for ORSP https://eresearch.umich.edu Log in from eresearch Homepage 1. Go to https://eresearch.umich.edu. 2. Click Login in the Proposal Management box. 3. Enter your Login ID (uniqname)
More informationTRAQ DSS Form. Researchers - User Manual
TRAQ DSS Form Researchers - User Manual January 2014 Introduction to TRAQ TRAQ (Tools for Research at Queen s) is an electronic research management system which replaced all internal certification paper
More informationLogging in to grantsera
Logging in to grantsera OFFICE OF GRANTS AND SPONSORED RESEARCH COASTAL CAROLINA UNIVERSITY What is grantsera? grantsera is an Electronic Research Administration system Professional Profile module stores
More informationDrexel University. Version April Page 1 of 23. Version April agf
Drexel University Page 1 of 23 TABLE OF CONTENTS Getting Started 3 IRB Protocol Committee Member Reviewer..4 Review IRB Protocol Submission..6 Enter Reviewer Comments... 7 Upload Reviewer Attachments......9
More informationReminder: Please refer to the 2018 Convening & Collaborating (C 2 ) competition page for more details.
Reminder: Please refer to the 2018 Convening & Collaborating (C 2 ) competition page for more details. The MSFHR ApplyNet system identifies the Researcher and Research User Co-Leads as Third Party Personnel.
More informationcopying a protocol in Kc irb training guide
copying a protocol in Kc irb training guide 2015, The Trustees of Indiana University 1 table of contents Table of Contents 2 table of contents 3 about this guide 4 copying a protocol 5 protocol actions
More informationIRBNet Picture Guide
IRBNet Picture Guide Instructions for On-line Submission of Research Protocols to the Institutional Review Board (IRB) www.irbnet.org For any questions or concerns regarding your submission, visit CSUSM
More informationNova Scotia Health Authority Research Ethics Board. Researcher s (PI) User Manual
Nova Scotia Health Authority Research Ethics Board Researcher s (PI) User Manual The Researcher s Portal is available through the Login at the following URL: http://nsha-iwk.researchservicesoffice.com/romeo.researcher/login.aspx
More informationKuali Coeus Implementation: IRB Progress Report. October 7, 2013
Kuali Coeus Implementation: IRB Progress Report October 7, 2013 IRB Presentation Outline Current State Documentation Future State Process Development KC-IRB24 Protocol Development-Submission Process Process
More informationDISCOVR-e USER MANUAL. Vanderbilt University Human Research Protection Program
DISCOVR-e USER MANUAL Vanderbilt University Human Research Protection Program Table of Contents Introduction and Overview... 3 Log into the System... 4 Investigator Dashboard... 5 Submitting a New Study...
More informationSUBMITTING AN IBC AMENDMENT
The submission of an amendment/modification to an approved IBC protocol requires the creation of a subsequent PACKAGE in a project. After an IBC application is approved, the project may require modifications
More informationCayuse IRB. Submitting a New Protocol. Office of Research Compliance (657)
Cayuse IRB Submitting a New Protocol Office of Research Compliance irb@fullerton.edu (657) 278-7719 How to use this tutorial This tutorial is written from the point of view of a Primary Investigator (PI),
More informationGuide for Candidates: Online Progress Reports
Guide for Candidates: Online Progress Reports What is Quest Quest is our comprehensive research management system used to administer and support research activity at Victoria University. All Progress Reports
More informationInsight 3.4: Release Date September 27, Help Desk/ Service Center # (If Available) Internal TFS # Description
Insight 3.4: Release Date September 27, 2013 Internal TFS # Help Desk/ Service Center # (If Available) Description Agreements- Patient Care Implement Patient Care Details for BWH Patient Care Details are
More informationGuide for Researchers: Online Human Ethics Application Form
Ethics & Integrity Research Office HUMAN RESEARCH ETHICS ONLINE APPLICATION October 2016/V1.03 Guide for Researchers: Online Human Ethics Application Form ENQUIRIES Senior Human Ethics Officer University
More informationerequest How to apply guide
Overview is an application that assists UCB in request life cycle management. UCB has clear guidance in place on what they can support or sponsor. Online requests will go through an internal review and
More informationHere s how this whole external IRB thing works: A handbook for external IRB submissions
Here s how this whole external IRB thing works: A handbook for external IRB submissions For all communication relating to external IRBs, call 414-219-7744 or email CentralIRB.Office@aurora.org. External
More informationeprotocol Investigator Role Manual
eprotocol Investigator Role Manual Table of Contents Table of Contents Auto-Population of Stored User Data...17 5.4 Module Specific Work Flow Sections...18 1 Overview...4 1.1 Things to Remember...4 2 Creating
More information