DU IRBNet User`s - University of Denver
Contents
1. able to obtain project documents from the lead site and may modify their copy of these documents such as consent forms to meet the requirements of their local Board You will be able to monitor the progress of this 7 y project at every local site The other local Principal Investigators will also be able to monitor the progress of this i project at every local site including your own Transfer Transfer your ownership of this project to another user In doing so you will relinquish all access to this Forms and Templates project and the designated user will be granted Full access Select University of Denver Colorado Seminary Denver CO from the organization box click Select Organization and search for registered users with whom you d like to share this project i e Co investigators Faculty Advisor Research Assistant etc Grant each user a level of ACCESS DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page9 You may share this project with other users Sharing a project consists of three steps 1 Select an organization to display a list of users at that organization 2 Specify the access that you wish to grant each user at that organization 3 Save your changes Research Institutions _ Boards _ Sponsors Organization types to display University of Denver Colorado Seminary Denver CO University of Erciyes Kayseri TURKEY PA University of Evansville Evansville IN2. Amendment Modification 06 25 2015 Administrative Modifications 06 30 2015 Review Required Amendment Modification 05 21 2015 Administrative Pending Review Review I4 4 1 20f2 gt pi poy Your curent document package has already been submitted and is presently locked by your Board You may prepare new or modified documents such as Revision Amendment materials Renewal Continuing Review materials and Adverse Event Reports by creating a new document packege A NEW DOCUMENT PACKAGE will appear as a Work in Progress Click on the New Document Package title and you will be brought to the DESIGNER screen where you can add your documents for this package Step 4 You will now be on the DESIGNER screen where you can add your documents for this package From the DU IRB Library Step 1 top of screen Select and download Final Report Application from the Select A Document drop down box From here choose File gt Save As to save document to your computer complete the Final Report Application and save to your hard drive Step 5 Attach supporting documentation for your closure of the study In the Document Type box pick the Closure Final Report document type in the drop down box If the type of document you are submitting is not in the list then choose Other and enter the type of document in the Description field Click the Browse button and find the document on your hard drive Once you find the do
3. DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page 1 Project A Project is an online version of the research protocol being submitted to the DU IRB Project Package A package is a submission containing any number of documents that are required by the IRB to conduct their review of a research Project i e initial project amendment continuing review etc Submission IRBNet uses the term Submission to denote a Project Package that has been submitted for official review by the IRB Principal Investigator IRBNet uses the term Principal Investigator PI to designate the person with overall responsibility for studies submitted to the DU IRB All studies must have a PI and all submission must include a PI signature Amendment Modification Amendment Modifications are changes that the researcher wishes to make after a study is approved by the IRB The researcher must submit an amendment modification package for IRB approval Revision A revision is a change or changes required by the IRB before a project or package can be approved The researcher creates a new Project Package in IRBNet to address any required revisions My Projects Lists all projects you have created You enter the study by selecting it from the list Create New Project Allows you to enter a New Study for submission The Initial Project package will include the appropriate applications the full research narrative any surveys or instrume
4. IRBNet User s Manual University of Denver Institutional Review Board IRB Human Subjects Protection Program Office of Research Compliance Version date 7 6 15 The DU IRB is responsible for ensuring that any research study under its jurisdiction is in compliance with federal state and institutional regulations All submissions must be submitted electronically to the DU IRB through IRBNet IRBNet is a hosted service that supports electronic on line submissions No hard copies will be accepted IRBNet can be accessed at the following web address The Web Address www irbnet org The purpose of this document is to provide guidance for submitting to the DU IRB via IRBNet Step by step instructions will be given for each type of submission If you have any questions and require additional assistance navigating through IRBNet program please contact the DU IRB Office of Research Compliance at 303 871 4050 Thank You Page 1 DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 oo a E Registration Instructions Instructions for Initial Submissions Create a New Project Completing the On line Document DU IRB Application Continuing Review Submission Instructions 0 eee Amendment Modification Submission Instructions 000005 Study Closure Submission Instructions 0 0 0 0 ce ees Adverse Events Protocol Deviatio
5. Page IRBNet Document Wizard DU IRB Application Form 761883 2 New Users to Navigate in IRBNet Jump To General Instructions V Jump General Instructions Completion of this form is the first step in seeking human subject research approval at the University of Denver This form is to be completed by the Principal Investigator All research personnel must submit proof of human subjects research certification a financial disclosure form and a confidentiality and conflict of interest statement as part of the submission process Answer all questions on this form completely include attachments and obtain all signatures prior to final submission on IRBNet The University of Denver IRB will process your application coordinate review and notify you of their determination Research activity may not begin until you receive notification of APPROVAL from the IRB Office Submissions to the IRB Office that are incomplete will be returned and not forwarded to the Review Committee for action Complete this form then click SAVE AND EXIT You do not need to complete the entire online form in one sitting you can save and exit and then go back and update the document by clicking the pencil icon next to the document listed in the designer When you have completed the DU IRB Application click Preview to see what the completed form looks like and confirm that all the information provided is accurate PLEASE NOTE All
6. x University of Florida Jacksonville Jacksonville FL University of Florida Gainesville FL University of Georgia Athens GA University of Guelph Guelph ON University of Hartford West Hartford CT Select Organization Select an Organization required fields Specify the access that you wish to grant to each user at University of Denver Colorado Seminary You should grant each user only the minimum level of access necessary to perform their work on this project Signature Only Read Users whose only role is to sign off on project documentation should be granted Read access Users with Read access can view project documentation communicate with the project team and add their signature This would typically include advisors department heads and other individuals who are required to sign off on the project documentation prior to submission but do not otherwise have a day to day role on the project Read Users that are granted Read access can view project documentation collaborate with other users and add their signature but may not edit project documents or perform any other administrative functions Write Users that are granted Write access can view and edit project documents collaborate with other users and add their signature but may not grant access to other users submit packages for review or perform any other administrative functions Full Users that are granted Full access can perform all functi
7. Assemble your document package In addition to adding project documents to your package IRBNet also allows you to link your project team s Training amp Credentials to your package New and Revised Documents in this Package There are currently ments in this package There are no Training amp Credentials records linked to this package Link Un Link Training Records IRBNet allows you to revise your existing project documents and maintain version history or add entirely new documents to your packaye Learn more When should do this Go to the On Line Document DU IRB Application at the bottom of the DESIGNER page and click ADD Attach Document A 883 2 New Users to Navigate in IRBNet You may attach documents to this package by clicking the Browse button to locate a document and then by clicking Attach The Document Type and optional Description are informational fields to assist you in managing your attached documents Document Type vi Fie required fields On Line Document DU IRB Application Form W Once you click ADD you will automatically be directed to the General Instructions for completing the DU IRB Application Form All fields with a red asterisk are required to be completed The online application does not allow the user to continue until that field has been completed DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015
8. Submitted by Du Researcher to Denver Admin Sarah Brenholt Jourdan Sherman Mary Travis at University of Denver DU IRB Denver CO on 06 25 2015 These users will automatically receive notification of this submission Return to the Project Overview Step 8 To review what has been sent click PROJECT OVERVIEW The submission will be under Pending review status until a decision has been made Once a decision letter is formulated an email will be sent to everyone who has full access and the letter and any supporting documents can be printed Keep in mind that once you click Submit your study is now locked and you can no longer make any other changes to this package Take the time to be sure all documents are attached and in the final version prior to submitting Any incomplete submissions will not be reviewed by the IRB and will be returned for corrections The submission of a study closure of an open study requires the creation of a subsequent package in a project DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page LD Step 1 Login to IRBNet www ironet org This will take you to the MY PROJECTS page Step 2 Click on the Title of the project that you would like to close Then click on the PROJECT HISTORY My Projects Create New Project is Project Package Des J igne re th this Forms and Templates Step 3 Click on the CREATE NEW PACKAGE button Project Status View
9. account number billing identifier or reference number for this project Internal Reference Number required fields Step 3 You will now be on the DESIGNER page where you will download forms templates and reference materials to assemble a new study Select University of Denver DU IRB Denver CO Documents for Researchers from the Select a Library drop down menu DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 PageO Designer 761883 2 New Users to Navigate in IRBNet Selecta Library Selecta DU IRB Exemption Application Form v Document Select the necessary forms that pertain to your initial submission from the Select a Document drop down menu Save these documents to your computer in a place where you can find them again i e desktop My Documents etc Click the Browse button and find the completed document on your hard drive Once you find the document click the Attach button to upload the document Assemble your document package through clicking on Add New Document until all documents have been added and use the checklist as a reference guide Label your document appropriately using the drop down list on the Attach Document screen i e Application Form Consent Form Protocol Letter etc Attach Document 761883 2 New Users to Navigate in IRBNet You may attach documents to this package by clic
10. ee Submission Manager Submissions for University of Denver DU IRB v The following submissions are available for your review Click on the project title to view more information about the submission and to access submitted documents Search S Only show submissions awaiting Board Action Search By Tag Re C Only show submissions not marked Review Completed Step 3 Scroll down to Training and Credentials and click on add a new training and credentials record DO NOT click on Add an External Account DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page O University of Denver DU IBC Denver CO Telephone Number 303 871 4049 Email mary travis du edu External Accounts You can add your accounts from other organizations such as CITI to your IRBNet profile Once you add an external account to your IRBNet profile then external information such as training records can be automatically available to you in IRBNet Learn More gt Add an External Account NO There are currently no external accounts in your profile Training amp Credentials IRBNet allows you to track and share your training records certifications resumes and other personal credentials Once added to your profile your training and credentials can be easily linked to your projects from the Designer are accessible by your project teams and can be quickly accessed an
11. m d Project History erview Project E t Mail x Forms and Templates Step 3 Click on the CREATE NEW PACKAGE button DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page LO Project History 761883 2 New Users to Navigate in IRBNet I4 4 1 202 gt pj 10 v Project Status View 2 Amendment Modification 06 25 2015 Administrative Modifications 06 30 2015 Review Required Amendment Modification 05 21 2015 Administrative Pending Review id 4 1 20f2 gt pi 10 v Your current document package has already been submitted and is presently locked by your Board You may prepare new or modified documents such as Revision Amendment materials Renewal Continuing Review materials and A NEW DOCUMENT PACKAGE will appear as a Work in Progress Click on the New Document Package title and you will be brought to the DESIGNER screen where you can add your documents for this package aid baiat Jve FTF Ew Se 761883 3 New Users to Navigate in IRBNet Research Institution University of Denver Colorado Seminary Denver CO Title New Users to Navigate in IRBNet Principal Investigator Smith John PhD The documents for this project can be accessed from the Designer Project Status as of 07 06 2015 University of Denver DU IRB Denver CO Deferred Modifications Required Package 761883 3 is Work in progress i4 4 Package 30f3 gt P Jump F This package has not been s
12. paged 1 A NEW DOCUMENT PACKAGE will appear as a Work in Progress Project Status as of 06 30 2015 University of Denver DU IRB Denver CO Deferred Modifications Required Package 761883 3 is Work in progress Id d Package 3of3 P PI Jump This package has not been submitted Click on the Work in progress title and you will be brought to the DESIGNER screen where you can add your documents for this package Step 4 You will now be on the DESIGNER screen where you can add your documents for this package Step 5 To revise an uploaded document doc xls pdf etc from a previous package First download the document by clicking on its Document Type or the paper icon If you will be revising a consent document be careful to ensure that the document you will downloading and revising is identical to the most current IRB approved version that sits in the Board Documents Section Make necessary changes and save the revised document to your computer Be sure to include BOTH a tracked changes version of your document showing what is changing as well as a clean copy for a new approval stamp You can find instructions on how to use tracked changes under the Forms and Templates tab under Other Tools Look for the document entitled GUIDANCE How to Use Track Changes in Documents Click on the pencil icon for that document on the Designer page Browse your computer and select your revised versi
13. the PI needs to sign the package electronically If you are a student send a Project Mail to your Faculty Advisor requesting them to sign the package Step 7 To sign a package click SIGN THIS PACKAGE The Principal Investigator or if applicable the Faculty Advisor MUST sign the package before it is submitted Select your appropriate role from the dropdown box and click Sign My Projects Create New Project My Reminders 2 Project Administration Project Overview _ Designer Share fhisRoject Sign this Package SubmitthisPackage _ Delete this Package Send Project Mail Reviews Project History iy Messages amp Alerts 2 Other Tools Forms and Templates If a submission is submitted without a PI signature or if applicable a Faculty Advisor signature the submission will not be accepted for review Step 8 Once the PI has signed the package click Submit this package Select University of Denver DU IRB Denver CO in the Search for Organization drop down menu this will be your default location and should be highlighted already Step 9 To review what has been sent click PROJECT OVERVIEW The submission will be under Pending Review status until a decision by the board has been made Once a decision letter is formulated an email will be sent to everyone who has full access and the letter and any supporting documents can be printed Keep in mind th
14. to have the package unlocked DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page 1 The submission of a continuing review of an open study requires the creation of a subsequent package in a project Step 1 Login to IRBNet www ironet org This will take you to the MY PROJECTS page This is where all of the studies that you have access to will be housed Step 2 Click on the Title of the project that you would like to continue renew click on the exact IRBNet project referenced in the e mail you received reminding you to renew your study Then click on the PROJECT HISTORY Step 3 Click on CREATE NEW PACKAGE Step 4 A NEW DOCUMENT PACKAGE will appear as a Work in Progress Click on the New Document Package title and you will be brought to the DESIGNER screen where you can add your documents for this package __ Project Status View Pkg Submission Effective pmission Type Date Review Type Board Action Date Amendment Modification 05 21 2015 Pending Review ld 4 1 20f2 p pl Step 5 You will be on the DESIGNER page This is where you can access the library of forms as well as any documents from previous packages you have submitted From the DU IRB Library Step 1 top of screen Select and download both Checklist Continuing Reviews and Continuing Review Application form the Select A Document drop down box From here choose File gt Save As to save th
15. 015 Page D When submitting the following items use the appropriate SUBMISSION TYPE within IRBNet Protocol Revision Amendment Modification Response to Approval with Modifications from the IRB Study Closure Closure Final Report Response to Additional Materials Request or follow up Revision from the IRB Reportable Event Non AE Reportable Event Non AE Information from Sponsor Notification to the IRB DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page dO
16. Day metrics The data you need From electronic submissions to form wizards to agendas minutes and Director Office of Research Intec ny more Our easy to use web based tools are rapidly launched and backed by our best practices ES 7 N di emp expertise and the industry s leading support team Marshall University DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Pape To submit a study for review you must first CREATE A NEW PROJECT Study to hold your documents Any type of document can be uploaded but your study MUST include all the required forms for a complete package before any action can be taken on behalf of the board A good place to start is Checklist New Submissions which includes a list of the required forms for a New Study This and other checklists can be found under Other Tools Forms and Templates on the left side of your screen Please note If you are submitting on behalf of the Principal Investigator Pl the PI must be registered in IRBNet so that he she can sign your package later in the submission process STUDENTS If you are serving as the Principal Investigator PI on this new project your Faculty Advisor must be registered in IRBNet so that he she can review and sign your package during in the submission process Step 1 Log In to www ironet org using you username and password for First Time Users you must Register with IRBNet please see INSTRUCTIONS FOR REGISTERIN
17. G WITH IRBNET page 3 Step 2 The default page will be MY PROJECTS where you will have access to all of your existing studies as well as the ability to create new studies Click CREATE NEW PROJECT on the left side of your screen ea E E k e My Projects Your My Projects workspace shows projects that you have created and projects that have been shared with you by other users on the National Research Network Use Reminders Tags and Archiving to help organize your workspace My Projects and keep it running smoothly Leam More Create New Froject san O O O syag Forms and Templates Id 41 1001 pi pay Create and Manage Tags Show Archived Projects 0 Project Status View C IRBNet ID T61883 1 New Users to Navigate in IRBNet I4 4 1 10f1 gt pi toy Fill in the relevant information about your project title PI name click Continue bs N Aa AN JRBNet 4 ia T7 Jes Project Information Create a New Project My Projects Create New Project To create a new project first provide the basic project information below Once your project is created you may attach project documentation and share the project with other users Research Institution University of Denver Colorado Seminary Denver CO Forms and Templates Title on First Name O Local Principal Investigator LastName _ Degree s _ Keywords _ OO O yy sponsor iY You may specify an internal
18. ange to a recently submitted project package contact the DU IRB Office at 303 871 4050 My Faculty Advisor says they signed up in IRBNet but cannot share the project with them Anyone can trigger an Activation email by logging into their account on IRBNet and clicking the link provided If they are not finding the Activation email in their inbox please have them check their Spam folder Once they opent he Activation email clicking the link provided will activate their account and allow them to log in on IRBNet How do I know if my Faculty Advisor has signed the package To Know when your Faculty Advisor has singe doff on a package asken them to click the send mail button when they have signed This wills end an automatically generate email form them letting your know they have signed If they do not do this you can log in and review if they have signed by clicking onthe SIGN THIS PACKAGE tab on the left of your screen This will bring you to a list of who has signed this study and when it was completed What level of access should your Faculty Advisor have It is up to you as the Principal Investigator to decide what kind of access shared individuals should have lt bears repeating those with full access will receive e mails when the IRB posts an action or decision What does my electronic signature mean The DU IRB requires that the Principal Investigator sign each submission If you are a student investigator your Faculty Advisor
19. at once you click Submit your study is now locked and you are not allowed to attach any other documents or make revisions Take the time to be sure all documents are attached documents have been carefully proof read and in the final version prior to submitting Any incomplete submissions will not be reviewed by the IRB and will be returned for corrections DU IRB Office of Re i IRBNet Users Manu Pace LS The submission of an amendment of an open study requires the creation of subsequent package in a project Step 1 Login to IRBNet www irbnet org this will take you to the MY PROJECTS page Step 2 Click on the Title of the project that you would like to amend modify Then click on the PROJECT HISTORY Step 3 Click on the CREATE NEW PACKAGE button and then the NEW DOCUMENT PACKAGE A NEW DOCUMENT PACKAGE will appear as a Work in Progress Click on the New Document Package title and you will be brought to the DESIGNER screen where you can add your documents for this package Step 4 You will now be on the DESIGNER page This is where you can access the library of forms as well as any documents form previous packages you have submitted T 761883 2 New Users to Navigate in IRBNet This package is Locked Get stamped documents approval letters and other board documents and track reviews for this package Review details Step 1 Download blank forms document templates and reference materials to assist you
20. cument click the Attach button to upload the document Repeat the steps to upload until all documents have been uploaded to your package DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page LO Step 6 When all required documents are uploaded to the package the PI needs to SIGN THIS PACKAGE electronically In order to sign a package select your appropriate role from the drop down box and click Sign If a submission is submitted without the PI signature or if you are a student researcher without a Faculty Advisor s signature the submission will not be accepted as complete Step 7 Once the package has been signed click SUBMIT THIS PACKAGE Select DU IRB Denver CO in the Search for Organization drop down menu this will be your default location and should be highlighted already Then click the Continue button In the Submission Type drop down menu select Closure Final Report and click Submit Once you hit the Submit button you will be given a confirmation showing the time your submission occurred Step 8 To review what has been sent click PROJECT OVERVIEW The submission will be under Pending Review status until an acknowledgement is granted Once a decisions letter is formulated an email will be sent to everyone who has full access and the letter and any supporting documents can be printed Keep in mind that once you click Submit your st
21. d tracked by the boards that review your projects Some boards also permit you to directly submit your training and credentials without requiring you to link these records to specific projects gt Add a New Training amp Credentials Record YES Step 4 Select the document type enter a description and put in the date you completed the course Browse and upload the certificate from your computer and click Attach Document Type CITI SBER Research Investigators Basic Course Description CITI SBER Basic Course Credits Credit Hours if applicable Effective Date Expiration Date e eg required fields DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 pager 7 Step 5 Click on Submit Training amp Credentials IRBNet allows you to track and share your training records certifications resumes and other personal credentials Once added to your profile your training and credentials can be easily linked to your projects from the Designer are accessible by your project teams and can be quickly accessed and tracked by the boards that review your projects Some boards also permit you to directly submit your training and credentials without requiring you to link these records to specific projects t Add a New Training amp Credentials Record all Versions 497382 1 CITI SBER Research cin SBER Basic 06 26 2015 07 06 2015 Not Investigators Basic Course Co
22. ds certifications resumes and other personal credentials Once added to your profile your training and credentials can be easily linked to your projects from the Designer are accessible by your project teams and can be quickly accessed and tracked by the boards that review your projects Some boards also permit you to directly submit your training and credentials without requiring you to link these records to specific projects t Add a New Training amp Credentials Record Show all Versions 197382 1 CITI SBI SBER Research CITI SBER Basic 06 26 2015 07 06 2015 Pending F Investigators Basic Course Course 11 29AM Review P Submit amp M DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 a29 What studies do have access to The MY PROJECTS screen can be found by clicking on My Projects on the left side of your screen This will show you the list of studies to which you have access those you have created and those which have been shared with you Studies which have not been submitted are labels Work in Progress in the Status column Studies which have been submitted but not reviewed by the IRB are labeled Pending Review Clicking on the title of any project will take you to the PROJECT OVERVIEW page for the selected project which contains project details What if I submit an incomplete package If you have forgotten to add a necessary document or need to make a quick ch
23. e document to your computer complete the Continuing Review Progress Report Application Form save it to your hard drive and use the checklist as a reference Step 1 Download blank forms document templates and reference materials to assist you in assembling your document package Select a 3 a T ry hrd oe University of Denver DU IRB Denver CO Selecta DU IRB Continuing Review Final Report Form Document View the On Line Document DU IRB Application and verify that the data accurately reflects the current status of your study If changes have occurred to your study that have not previously been reviewed and approved by the IRB then an amendment modification will be required Attach supporting documents for your continuing review package by clicking on the Add New Document button and browsing your computer In the Document Type drop down box pick the best match for the document you are uploading If it is the application choose the Continuing Review Progress Report choice If the type of document you are submitting is not in the list then choose Other and enter the type of document in the Description field DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Pace LD Click the Browse button and find the document on your hard drive Once you find the document click the Attach button to upload the document Step 6 When all required continuing review documents are uploaded
24. ed documents Step 3 Click the DESIGNER 761883 1 New Users to Navigate in IRBNet This package is Locked Get stamped documents approval letters and other board documents and t Step 1 Download blank forms document templates and reference materials to assis Selecta Library University of Denver DU IRB Denver CO Vv Selecta DU IRB Amendment Form Document Step 2 Assemble your document package In addition to adding project documents Documents in this Package Amendment Modification There are no Training amp Credentials records linked to this package DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Paced 4 From here you can upload revised documents for your study by clicking on Add New Document Browse for your revised documents and any other relevant information from your computer and assign the proper Document Type from the drop down menu Click Attach Step 4 To relock the package Click on Mark Revisions Complete Designer 761883 1 New Users to Navigate in IRBNet This package is pi Unlocked Revisions Pending View History Mark Revisions Complete Wien should do this Get stamped documents approval letters and other board documents and track reviews for this package Review details Step 1 Download blank forms document templates and reference materials to assist you in assembling your document package Calaa a Desi
25. fficient and timely manner To review what has been sent click PROJECT OVERVIEW The submission will be under Pending Review status until a decision has been made Take the time to be sure all documents are attached and in the final version prior to submitting Incomplete submissions will be unlocked by the IRB Office and the IRB review will be delayed An email will be sent to the PI identifying the missing documents or items in the package DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page 3 During the IRB administrative preliminary review each submission will be evaluated for completeness If a submission is incomplete the PI will receive an email that lists what is missing or what changes need to be made to the document Step 1 Login to IRBNet www irbnet org This will take you to the MY PROJECTS page OF alee 477 My Projects Your My Projects workspace shows projects that you have created and projects that have been shared with you by other users on the National Research Network Use Reminders Tags and Archiving to help organize your workspace and keep it running smoothly Learn More Search By Tag Id 4 1 10f1 gt pi poy Create and Manage Tags Show Archived Projects 0 Project Status View 761883 1 New Users to Navigate in IRBNet id 4 1 10f1 gt py id v Step 2 Click on the Title of the project of which you are submitting missing and or correct
26. gner View Histo Mark Revisions Complete When should I do this When you mark revisions complete your package will be automatically re locked and your committee coordinators will be automatically notified You may also specify an optional message to be included in this automatic notification Your it paj message will be automatically posted to the Lock History for this package and to the Project Messages amp Alerts where it will become part of the project record and can be viewed by any user with access fo this project including Committee Members and Administrators that review this project Message Continue Cancel a 2X Step 5 Check the status of your review Go to Review Details Review Details include Agenda Date Review Type Status Effective and Expiration Dates and Board Documents DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page2D aA ar CI i Collaborative Institutional Training Initiative Search Knowledge Base Q an at the University of Miami au PROGRAM y www Citiprogram org Step 1 After you have successfully completed the required modules click on Print Report Save as CITI Training Certificate on your computer University of Denver Courses Course Status Survey SBER Research Investigators Print Report Post course evaluation 06 26 2015 Step 2 Log onto www IRBNet org and click on User Profile wm d
27. ignature or Faculty Advisor s signature the submission will not be accepted for review Step 7 Once the PI has signed the package click SUBMIT THIS PACKAGE Select University of Denver DU Denver CO in the Search for Organization drop down menu This will be your default location and should be highlighted already My Projects Create New Project Project Overview Designer Submit this Pacwage Project History fi i Forms and Templates Then click the Continue button In the Submission Type drop down menu select New Project and click Submit Once you hit the Submit button you will be given a confirmation showing the time your submission occurred Step 8 To review what has been sent click PROJECT OVERVIEW The submission will be under Pending Review status until a decision by the board has been made Once a decision letter is formulated an email will be sent to everyone who has full access and the letter and any supporting documents can be printed NOTE Keep in mind that once you click Submit your study is locked and no other changes can be made to this package Take the time to be sure all documents are attached and in the final version prior to submitting Any incomplete submissions will not be reviewed by the IRB and will be returned for corrections If you need to make any changes after the package has been submitted and locked please contact the IRB Office to request
28. in assembling your document package Se lecta University of Denver DU IRB Denver CO v Library Selecta DU IRB Amendment Form Document Step 2 Assemble your document package In addition to adding project documents to your package IRBNet also allows you to link you New and Revised Documents in this Package Description Amendment Modification Amendment Modification 5 21 15 Thara ara nn Trainina amp Cradantiale rarnrdc linkar tn thie narkana From the DU IRB Library Step 1 top of screen Select and download both Checklist Amendment Modifications and Amendment Modification Application from the Select A Document drop down box From here chose File gt Save As to save the amendment document to your computer complete the Application Form save to your hard drive and use the checklist as a reference guide If the amendment changes any of the data included in the previously approved On Line Document DU IRB Application i e personnel study locations contact information then this form will need to be updated as a part of your amendment submission Attach supporting documents for your amendment package by clicking on the Add New Document button and browsing your computer In the Document type drop down box pick the best match for the document you are uploading If it is the application choose the Application Form choice If the type of document you are
29. ions are Required then you need to submit a Revision Step 1 Login to IRBNet www ironet org This will take you to the MY PROJECTS page Step 2 Click on the Title of the project that your submitting revisions to and click on the PROJECT HISTORY B FErC _ My Projects Your My Projects workspace shows projects that you have created and projects that have been shared with you by other users on the National Research Network Use Reminders Tags and Archiving to help organize your workspace and keep it running smoothly Learn More seareneyTag F Sean Gear I4 4 1 10f1 gt pi 10 Create and Manage Tags Show Archived Projects 0 Project Status View 761883 1 New Users to Navigate in IRBNet Smith id 4 1 10f1 gt pi 10 y Step 3 Click on the CREATE NEW PACKAGE button and then the NEW DOCUMENT PACKAGE Project Status View Amendment Modification 06 25 2015 Administrative Modifications 06 30 2015 Review Required 1 Amendment Modification 05 21 2015 Administrative Pending Review Review 14 4 1 20f2 gt pi Your current document package has already been submitted and is presently locked by your Board You may prepare new or modified documents such as Revision Amendment materials Renewal Continuing Review materials and Adverse Event Reports by creating a new docuar nt package DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015
30. king the Browse button to locate a document and then by clicking Attach The Document Type and optional Description are informational fields to assist you in managing your attached documents Document Type Description i required fields You may also use the Document Wizards to create documents on line Documents that you create on line are automatically attached in PDF format On Line Document DU IRB Application Form W Aad Cancer Once you have attached a document to your study package the Study Designer page will now list your documents PLEASE NOTE THE ON LINE DOCUMENT DU IRB Application Form MUST ALSO BE COMPLETED Please refer to the instructions for completing this application on the following page DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 page Please Note The On line Document provides detailed information about your study that may not be listed in the protocol or the informed consent The On line Document MUST be completed for ALL initial submissions Go to the Designer page and click on Add New Document Designer 761883 2 New Users to Navigate in IRBNet Step 1 Download blank forms document templates and reference materials to assist you in assembling your document package Selecta f Library University of Denver DU IRB Denver CO W Selecta DU IRB Exemption Application Form v Document Step 2
31. mplete the registration process by logging in to IRBNet and accessing your User Profile Search for an organization University of Denver Coloradi Organization types to display V Research Institutions L Boards L Sponsors Display University of Erciyes Kayseri TURKEY PA University of Evansville Evansville IN University of Findlay Findlay OH University of Florida Jacksonville Jacksonville FL University of Florida Gainesville FL University of Georgia Athens GA University of Guelph Guelph ON University of Hartford West Hartford CT University of Hawaii at Hilo UH Hilo HI University of Hawaii at Manoa Honolulu HI University of Houston Houston TX If you do not see your organization listed you may add a new organization Continue Cancel Your Organization required fields 6 Enter your contact information Enter the email address you will use to receive communications through the IRBNet system regarding all notifications of IRB decisions communications from the IRB Office and or your research Click Continue Telephone Number __ _ Fax Number C J L i emal _ Verity Email required fields 7 Review the information you provided and edit as necessary When you are satisfied click Register IMPORTANT An email will be sent to the email address you provided in Step 6 with IRBNet Activation Required in the subject line If you do not receive the confirmation i
32. must also sign each submission Having a Faculty Advisor sign each submission indicates that they have reviewed and approve your submission As the Principal Investigator your electronic signature that is associated with a given project means that eh research described in the application and supporting materials will be conducted in full compliance with DU IRB s policies and Federal regulations governing human subjects research DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page 3 Locked vs Unlocked Status Once a study is submitted to the IRB it will be LOCKED Package can only be unlocked by the DU IRB Administrative staff This can be done if you let us know that you ve made an error in something that you just submitted or if we let you know that we see something that is missing or needs to be fixed When you need to respond to a DU IRB review or if you want to submit an amendment or continuing review you will CREATE NEW PACKAGE for the project by adding documents in the DESIGNER for that project I have submitted a Continuing Review application why am still receiving an IRBNet 30 day Project Expiration Reminder Reminders are automatically generated until the submission has been approved by the IRB IF you can see the Continuing Review submission in PROJECT HISTORY the IRB staff has access to it PROJECT HISTORY will show the Status as Pending Review until a determination letter is issued by the IRB
33. n a short period of time then check your DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 paged junk folder to see if it is there You will need to click on the link provided in this registration email in order to activate your account Clicking on the link will take you automatically to the IRBNet homepage If you have problems activating your account or have forgotten your password please click on the Forgot your Password text in the upper right corner of the IRBNet home page Usemame Passwors g New User Registratipn IRBNet Innovative Solutions for Login Compliance and Research Management FAQ Forgot Your Password Home The IRBNet Difference Demo Contact Us Comprehensive Solutions Test Drive IRBNet See for yourself Satisfied Members The Industry s Most Complete Solution IRBNet s unmatched suite of electronic solutions drives compliance and productivity for your Our first electronic meeting Administrators Committee Members Researchers and Sponsors These powerful research design management and oversight tools support your IRB IACUC IBC COI and other Boards with a unified solution went so smoothly It was over so fast the members didn t know what to do They just sat there Flexible Intuitive and Easy to Use for a few minutes in disbelief Your own forms Your own processes Your own standards Powerful reporting and performance Bruce
34. ns and Unanticipated Problems Response to Modifications Required 0 0 cc eee Incomplete Submissions DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Instructions for Attaching CITI Training Certificate 00005 Frequently Asked Questions FAQS 0 0 ccc eee ees Explanation of IRBNet Terms Glossary How to Label Your Submission Types pape 1 Go to http www ironet org 2 Click on the New User Registration link in the upper right hand corner of the screen 3 Create your username and password Fill out the required information Your password must contain 8 characters Click Continue FirstName i LastName usemame s U pasword sd ConfirmPassword O PasswordHint 0 i le Cancel required fields 4 Read and Accept the Individual User Terms of Use 1 Acceptance of Terms This Agreement governs your participation as an individual user of IRBNet IRBNet is a service provided by Research Dataware LLC and both the company and service name are used interchangeably in this Agreement In addition when using particular IRBNet owned or operated services you shall be subject to any posted guidelines or rules applicable to such services which may be posted from time to time All such guidelines or rules are hereby incorporated by reference into this Agreement IRBNet may also offer other services that are governed by different Terms
35. nts consent forms and any other required documents Project Overview Summarizes the selected project displays the status and documents Allows you to submit the package for review and share with other IRBNet users Designer This page contains two steps Step 1 lists the document library where you can find forms to guide you or to fill out i e checklists applications Step 2 allows you to upload your documents to a package This is called Assemble our document package This means you are putting your proposal together Share this Project Allows you to share your project with other registered IRBNet researchers Sign this Package All packages must include the Principal Investigator signature prior to submission For student investigators all packages must include their Faculty Advisor s signature prior to submission Submit this Package After the PI signs the package you will need to submit the package to the DU IRB Once you submit a package it remains in the system permanently Delete this Package IF you want to remove the package completely this cannot be undone Send Project Mail Allows you to send an e mail between members of the project team Project History Lists the Actions related to this project Board Documents These are decision documents and stamped documents issued by the board in response to your package submission DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2
36. of Use If this Agreement or any future changes are unacceptable to you your sole remedy is to terminate your use of the Service If you do not accept and abide by this Agreement you may not use the services offered by IRBNet By accessing or using the Service you confirm your acceptance of and agree to be bound by this Agreement and any future changes to this Agreement You agree to use the Service only in accordance with this Agreement Nothing in this Agreement shall be deemed to confer any third party rights or benefits Modification of Terms Although we may attempt to notify you via your submitted e mail address when major changes to the Agreement are made you should visit this page periodically to review these terms IRBNet may in its sole discretion modify or revise these terms and conditions and policies at any time without notice to you and you agree to be bound by such modifications or revisions DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 PageD 5 To add your affiliation type the word University of Denver Colorado Seminary Denver CO into the search box Click Display Select University of Denver Colorado Seminary Denver CO from the organization box Click Continue Registration Add Affiliation Specify the organization with which you are affiliated If you are affiliated with more than one organization you may add additional affiliations after you co
37. on of the document to upload make changes to the Document Type and Description as appropriate and click the Update button If you need to add a new document then click on the Add New Document button To revise the DU IRB Application Form from a previous package for committee review DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 page 2 Click on the pencil icon for the IRB Application Form This will open up the DU IRB Application Form IRBNet Document Wizard screen Use the Jump To feature in the upper right corner of the IRBNet Document Wizard page to Jump to the section that you are revising Click on the Save and Exit button when you have made all of your changes The document will move to the New and Revised Documents in this Package section on the DESIGNER page Step 5 Click SIGN THIS PACKAGE The PI signature is required for all submissions If you are a student researcher your Faculty Advisor must also sign the package Step 6 Click on SUBMIT THIS PACKAGE click on DU IRB Denver CO in the Select Organization box Then click on Continue In the Submission Type drop down menu select Revisions and click Submit In the Your Comments section specify what the revision is for i e response to new study submission amendment submission continuing review submission etc This will assist the board in processing your revision in a more e
38. ons without restriction This includes editing project documents sharing the project with ole users amane document packages for review and deleting document packages Only Project Owners mith rthe 2 project should be granted Full access Users with Full access will reco atens and alerts that are sent to the Project Owners Search for a User To Share your research with someone they must be registered with IRBNet org Selected users will be notified automatically via email that the project has been shared with them and you may enter comments to be included within the email Step 5 When all the necessary documents are uploaded to the package the Principal Investigator must sign the package electronically If you are completing this package on behalf of the PI send an email to the PI using the Send Project Mail function and request that the PI sign the package If you are a student send an email to your Faculty Advisor using the Send Project Mail function and request that the Faculty Advisor sign the package Step 6 Click on SIGN THIS PACKAGE The Principal Investigator MUST sign the package before it is submitted Select your appropriate role from the dropdown box and click Sign DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 pace LO My Projects Create New Project Sign this Pack Package Delete this Package Reviews If a submission is submitted without the PI s
39. other IRB forms are to be completed saved to your hard drive and attached to the submission package Step 4 SHARE THIS PROJECT with your research team and if a student investigator with your Faculty Advisor Click the Share this Project button on the left side of your screen click the blue Share link to grant access to this project You may share this project with other Researchers Committee Members Administrators and Sponsors You may also send a complete copy of this project to a Principal Investigator at another site if this is a multi site project You may also ansfer ownership of this project to another individual Share Use this option if you wish to share your project with other Researchers Committee Members Administrators or Sponsors at your own institution or any other institution For example you may wish to share this project with other members of your research team so that you may collaborate in the design and development of the project or with a selected Committee Member or Administrator to solicit feedback prior to submitting your project for review You may provide any individual with Full Write or Read access Submit this Package Delete this Package z Multi site Use this option only if your project is a multi site project and you wish to send a complete and independent copy of this project to a Principal Investigator at another site The local Principal Investigator will be Reviews
40. submitting is not in the list then chose Other and enter the type of document in the Description field Click the Browse button and find the document on your hard drive Once you find the document click the Attach button to upload the document DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page 14 Repeat the steps to upload until all document s have been uploaded to your package Step 5 When all documents are uploaded the PI needs to sign the package electronically If you are a student send an email Send Project Mail to your faculty advisor and have then SIGN THIS PACKAGE Step 6 To sign a package click SIGN THIS PACKAGE The Principal Investigator MUST sign the package before it is submitted Select your appropriate role form the dropdown box and click Sign Step 7 Once the package has been signed click SUBMIT THIS PACKAGE Select DU IRB Denver CO in the Search for Organization drop down menu This will be your default location and should be highlighted already Then click the Continue button In the Submission type drop down menu select Amendment Modification and click Submit Once you hit the Submit button you will be given a confirmation showing the time your submission occurred Submit Package Submission Confirmation 761883 2 New Users to Navigate in IRBNet This package has been successfully submitted for review
41. ubmitted Step 4 You will now be on the DESIGNER screen where you can add your document for this package From the DU IRB Library Step 1 top of screen Select and download the appropriate form for your submission type from the Select A Document drop down box From here choose File gt Save As to save the document to your computer complete the appropriate form s and save to your hard drive DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 page LO Step 1 Download blank forms document templates and reference materials to assist you in assembling your document package z University of Denver DU IRB Denver CO Vv Select a DNIRB Amendment Form Document Download Step 2 Assemble your document package In addition to adding project documents to your package IRBNet also allows you to link y New and Revised Documents in this Package Add supporting documentation to your submission as appropriate Attach supporting documents for your package by clicking on the Add New Document button and browsing your computer Label your documents appropriately using the drop down list on the Attach Document screen Step 5 When all required documents are uploaded to the package the PI needs to SIGN THIS PACKAGE electronically In order to sign a package select your appropriate role from the dropdown box and click Sign Note If a submission is submitted
42. udy is now locked and no other changes can be made to this package Take the time to be sure all documents are attached and in the final version prior to submitting Any incomplete submissions will not be reviewed by the IRB and will be returned for corrections DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 page L The Submission of an Adverse Event Protocol Deviation or Unanticipated Problem will require the creation of a subsequent package in a project If you are unsure whether to submit as an adverse event or a reportable event contact the IRB Office at 303 871 4050 for assistance Step 1 Login to IRBNet www irbnet org This will take you to the MY PROJECTS page My Projects Your My Projects workspace shows projects that you have created and projects that have been shared with you by other users on the National Research Network Use Reminders Tags and Archiving to help organize your workspace and keep it running smoothly Learn More Id 4 1 10f1 gt gt i OY Create and Manage Tags Show Archived Projects 0 Project Status View IRBNet ID v amp 761883 2 New Users to Navigate in IRBNet T Smith Amendment Modifications 06 30 2015 Modification Required Id 4 1 10f1 gt gt i 0y Step 2 Click on the Title of the project of which you are reporting Then click on PROJECT HISTORY button My Projects Create New Project Proj t S Submit th Send Pro Reviews
43. urse 11 29AM Submitted Submit z Step 6 Select the correct board University of Denver DU IRB Denver CO and click Continue A confirmation will appear As the final step click Submit Submit Training amp Credentials Step 1 Select a Board Certain Boards allow you to directly submit your Training amp Credentials Alternately you may link your Training amp Credentials to any package on the Designer and then submit the entire package 197382 1 CITI SBER Research Investigators CITI SBER Basic Course 06 26 2015 07 06 2015 Basic Course 11 29 AM You are submitting the following record Please select a Board Search tora Boara sean cear V Only show My Default Boards University of Denver DU IRB Denver CO University of Denver DU IACUC Denver CO University of Denver DU IBC Denver CO DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Page mem o mnan a ag Me Mo e e e e a a a e Step 2 Confirm and Submit 197382 1 CITI SBER Research Investigators CITI SBER Basic Course 06 26 2015 07 06 2015 Basic Course 11 29 AM You are submitting this record to the following Board University of Denver DU IRB Denver CO You may also send an optional message to the Board along with this submission Subject New Training amp Credentials Submission Training amp Credentials IRBNet allows you to track and share your training recor
44. without the PI signature or without a Faculty Sponsor signature the submission will not be accepted for review Step 6 Once the PI has signed the package click SUBMIT THIS PACKAGE Select DU IRB Denver CO in the Search for Organization drop down menu This will be your default location and should be highlighted already Then click on the Continue button In the Submission Type drop down menu select the appropriate submission type either Adverse Event or Protocol Deviation and click Submit Once you hit the Submit button you will be given a confirmation showing the time your Submission occurred To review what has been sent click PROJECT OVERVIEW The submission will be under Pending Review status until an acknowledgement is granted or an action has been taken Once decision letter is formulated an email will be sent to everyone who has full access and the letter and any supporting documents can be printed Keep in mind that once you click Submit your study is now locked and no other changes can be made to this package Take the time to be sure all documents are attached and in the final version prior to submitting Any incomplete submission will not be reviewed by the IRB and will be returned for corrections DU IRB Office of Research Compliance IRBNet Users Manual v 1 June 2015 Paced O If you have submitted a package and the full board has determined that Modificat
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