IRBNet instructions - Riverside County Regional Medical Center
Contents
1. save a copy of your CITI or NIH completion report to your computer so that it can be uploaded into IRBNet e On the top right hand corner of the IRBNet web page you should see a link called User Profile Click on that link and it will bring you to a page where you can manage your IRBNet user profile Near the bottom is a section called Training amp Credentials If you haven t uploaded any training then this section will be blank Click the button Add New Record e Select the appropriate training from the drop down list in the Document Type field e Upload documentation of your training by choosing the file from a saved place on your computer After you have uploaded your training and credentials by clicking attach you will be brought back to your user profile After you have confirmed that your training is correctly identified make sure you submit that training to the Riverside County Regional Medical Center RCRMC IRB for review by clicking the submit link for each training and credential record After you click submit an email will be sent to the board with b information about your training Please see the Riverside County Regional Medical Center RCRMC IRBNet User Manual for more information Create New Project On the left hand side of the screen you should see an option for Create New Project Left click on that button You will be prompted to enter information about the study a title2. In order to share your project click Share this Project on the left hand side of your screen e In most cases you will choose the Share option rather than Multi site or Transfer Once you have selected Share blue text choose Riverside County Regional MC RCRMC from the drop down list of organizations e Before you can share the study the person you are sharing it with must Register with IRBNet IRBNet org following the instructions in the upper right hand corner Complete the User Profile and Affiliate Riverside County Regional MC RCRMC unless a Co PI is located at a different institution Reply to the IRBNet email to complete registration e You can search for an individual by typing in the first letter of the individual s last name any letter of their full name or to list all users and click on the Search icon e After you have identified the individual to whom you would like to give access place a mark in the appropriate level of access next to the research team member s name e If you need the selected personnel to sign the package e g PI faculty advisor Riverside County Regional Medical Center sponsor please include a message to them in the Your Comments section at the bottom of 4 this page asking them to sign the package You might also include instructions as to how they assess and sign the package Permissions Full User may manage all aspects of
3. solution is accessible to your research community anytime anywhere Our enterprise class technology is cost effective and designed to accommodate institutions of any size 2011 Events Join Us 7 h PRIM amp R Annual IACUC Conference z Chicago IL March 31 April 1 Iry the demo and see for yourself AAHRPP Annual Conference Washington DC April 6 8 NAIM Annual Conference Atlanta GA April 28 29 HCCA Research Compliance How do I register in IRBNet e Click on the New User Registration icon located below the login at the top right corner of the page circled in red above Complete the registration information A registration email will be sent to the email address you provided You will receive an initial email when you register and a second email when your RBNet account has been activated Once your account has been activated you should be able to login to IRBNet I m registered and I want to submit my first new submission what should I do a Training amp Credentials e Ifyou have not already completed the required CITI or NIH Protecting Human Research Participants training it will be necessary to complete this training Although you can begin to create your submission before you have completed the training your project cannot be approved until you have completed the required human subjects protections training and uploaded documented completion within IRBNet To document completion of the training
4. the project The user may give and change permissions associated with the project Write User may co edit the project with owner but not give or change permissions Any changes a person with write access makes to a document using the project designer will automatically transfer across to the owner s copy Read User may only access a read only PDF of the project All other management features are disabled Use this level of permission if you only need that person to sign the project e Now that you have shared your project will all appropriate personnel you must link training and credentials from user profiles to your project package You can only link training and credentials for yourself and people with whom you have shared the project Therefore as noted previously if you are including other personnel who will interact or intervene with participants who will have access to identifiable information or who will collect data and you will not share the project with these individuals you will need to upload their CITI or NIH Protecting Human Research Participants certificates as supplementary documents e Linking training and credentials to a project Start by going to the Designer page for your project On the left hand side of your screen click the Designer link From the designer page click on the link for Link Un Link Records Designer 46270 1 Project 1 Step 1 Download blank forms document templates an
5. 1 Read Me First A Brief Overview of IRBNet How do I get to IRBNet e Type www irbnet org into the address bar of your Internet web browser The home page will look like this IRBNe Innovative Solutions for Ti E ES Compliance and Research Management New User Registration J Forgot Your Password Home TheIRBNet Difference Demo ContactUs FAQ Comprehensive Solutions Test Drive IRBNet 7 5 gane h g a 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 went so smoothly It was over management and oversight tools support your IRB IACUC IBC COI and other Boards with a unified so fast the members didn t know poknion what to do They just sat there ae for a few minutes in disbelief Flexible Intuitive and Easy to Use Your own forms Your own processes Your own standards Powerful reporting and performance 7 metrics The data you need From electronic submissions to form wizards to agendas minutes and Director Office of Research Integrity Bruce Day more Our easy to use web based tools are rapidly launched and backed by our best practices Marshall University expertise and the industry s leading support team Secure Reliable and Cost Effective IRBNet s secure web based
6. 2012 12 33 PM ae Sharing a project After you have completed your protocol application you must share your project with relevant personnel We recommend that you share the project with any personnel who will need to read revise or sign the submission package Project Overview Designe 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 transfer 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 e 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 able to obtain project documents from the lead site and may modify their copy of these documents such as consent fo
7. B s determination and modification request Log into IRBNet Select the project Select the Study Designer from the administrative menu Click on the blue hyperlink for the Modification Request letter from the IRB This will download a copy of the letter to your computer re ae ee When responding to the IRB s modification request create a new package to maintain the study s chronological P g q P g y 8g history To make revisions 1 Complete your revisions as requested Save the revised documents to your computer Sign into IRBNet and select the correct project from the My Projects page Do this by clicking on the name of the designed project On the toolbar on the left side of the screen you should see a Project History button Click on this button to see all the packages that have been started for your project From the project history page click Create New Package Your screen should now look something like this please note that the background should not be green Project History 46373 1 IRBNet training test of submission process The following document packages are available in Project History Work in progress 01 24 2012 Modifications Required 01 24 2012 01 24 2012 01 23 2012 New Document Package aa E 5 After clicking Create New Package you should see a new entry in the list of packages This entry should be titled New Document Package Click o
8. b principal investigator name and title c key words d sponsor and e internal reference number The title information and principal investigator information you include here will be used throughout your submission so make sure you check it for accuracy The principal investigator PI is the individual who will be responsible for the conduct of the project Although we strongly recommend that the PI be the individual generating the project paperwork this is not a requirement If project paperwork is being completed by someone other than the PI e g research coordinator please share this document with the PI so that both parties have full access Directions on how to share are outlined below Students residents and fellows MUST have a designated RCRMC faculty member as the PI principal investigator as they are ultimately responsible for the conduct of the study In the keywords field please specify keywords that can be used in a search to find this project In the sponsor field list the name of the funding agency sponsoring the project if applicable and upload the funding application and approval when appropriate If the project is unfunded leave the sponsor field blank Finally we ask that you leave the institutional reference number field blank After you have completed all the appropriate fields click continue Clicking continue automatically saves your data On the next page Designer page you will be able to download d
9. d reference materials to assist you in assembling your document package Select a Library University of North Florida Institutional Review Board Jacksonville FL z Select a Document READ ME FIRST gt Downoad Create New Project Step 2 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 Documents in this Package There are currently no documents in this package There are no Training amp Credentials records linked to this package Forms and Templates From this page Linking Training amp Credentials page select the appropriate CITI NIH training you would like to link for each user At a minimum appropriate CITI NIH training must be linked for the PI of the project 5 Finally after reviewing all documents and verifying that the submission is just the way you want it you can sign the package in preparation for submittal Signing the Package Select Sign this Package from the Project Administration bar on the left hand side of your screen This will allow you to sign the package Select your role in the study from the drop down list and click sign When you shared the project with other users you should have specified if you want them to sign the package before it is submitted If you did not do this you can send them a message internally through IRBNet in the S
10. ease note that this additional package will not be reviewed until after the first package is reviewed Additionally submitting a new package before you have received review comments may elongate the review timeline for your project 8 Where can I go to find more information about Riverside County Regional Medical Center s research integrity program and IRBNet e See the Research IRB tab located under Medical Staff Services on the RCRMC intranet http intranet rcrmc local website Included here are forms instructions FAQs and other helpful information for persons wanting to submit their research proposals for IRB review e Additional information can be found on the IRBNet Forum 9 Who can I contact if I have questions Hayley S Lee MPH Research Specialist II HayLee co riverside ca us
11. en as subjects o IRB approval from collaborating institutions o RCRMC Departmental Approval s for non RCRMC affiliated researchers Continuing Review Renewal e Progress Report e Continuing Review Application Amendments Modifications e Changes in Research Application e Changes in Research Personnel Study Personnel List Closure Final Report e Research Completion Report e Request to Publish Present Unanticipated Problem or e Unanticipated Problem or Adverse Event Adverse Event Reporting form s Adverse Event Instructional Resources e Proposal Primer e Instructions for Research Study Submissions e Guidelines for Completing the Financial Disclosure Form e Guidelines for Written Consent e Definition of Limited Data Set 10 2012 e Conflict of Interest FAQs e When Reviewing a Proposal e Conflict of Interests Information After you have completed obtained from Attach Document page or self generated all of the supplementary documents these documents must be added to IRBNet Do this by clicking Add New Document at the bottom of the designer page On the Attach Document page you should select the document type you are uploading from the drop down list e g Application Form Consent Form Questionnaire Survey If you do not see an option that describes your document type please choose other and then add a description of the document to the description field Addit
12. end Project Mail function of your project administration bar on the left hand side of the screen Submitting the Package After your project package is complete and signed by all necessary persons you can submit the package by clicking Submit this Package on the Project Administration bar on the left hand side of your screen Select Riverside County Regional MC RCRMC from the list of organizations and then click Continue Select the submission type from the drop down menu If this is a new submission select New Project from the list of options If you have comments that you would like to send to the research integrity administrators and or reviewers please include that information in the Your Comments section of the page Click Submit when you are done 4 How do I submit revisions The IRB may request modification s to the protocol application or supplementary documents e g attachment A recruitment materials informed consent documents You will receive an email notification from the IRB informing you that the IRB has made a decision The board may publish a response to your submission by making a document available for you to review This letter may ask you to make modifications or it may indicate that your project has been approved or disapproved It is the responsibility of the research team to log into IRBNet to view these documents and address any modifications requested To view the IR
13. etween a project and a package in IRBNet e A package is a bundle of documents e g protocol application consent forms measurement tools training amp credentials The term project is a blanket term for all of the packages that make up a submission e When it is time for you to submit revisions a new package will need to be created that contains all of the revised documents 7 Isubmitted my package but I need to make changes to one of the documents in the package What should I do Project History 46373 1 IRBNet training test of submission process The following document packages are available in Project History Work in progress 01 24 2012 gt New Project Modifications Required 01 24 2012 01 24 2012 01 23 2012 2 Packages found displaying all Packages Erinmay viewing this package e First please contact an IRB administrator to discuss your submission This may save you valuable time and energy Contact information for administrators can be found below e After submission the package you submitted will be locked which means that you will not be able to adjust any of the submitted documents in the package nor will you be able to add or remove any documents This is important because it could cause confusion and problems if a researcher were to change a document while it was under review e Please do not submit a new package while the initial package is still under review If you do generate a new package pl
14. ionally if you are including other personnel e g research assistants data collectors it will be necessary to include information about their training and credentials All Co PIs data collectors personnel who interact or intervene with participants and personnel who have access to identifiable information are required to complete CITI training If you will not share the project with these individuals i e give them read or write access to your project documents you will need to upload their CITI or NIH completion reports as supplementary documents More information about project sharing is included below Upload the file by clicking Choose File and then selecting the document from where it is saved on your computer Once you have selected the correct document file from your computer click the Attach button You can only add one document at a time You can now complete the IRB protocol application The application begins with instructions Complete each section as appropriate If you must stop part way through make sure you save your progress by clicking Save and Exit at the bottom left corner of the application If you save and exit make sure that when you come back to continue your progress select the project on which you will work and select the document from your document list in your designer page by clicking the pencil icon Description Last Modified North Florida IRB Protocol North Florida IRB Protocol 01 12
15. n the link for New Document Package to begin your new package circled in red above 6 Write a letter or memo that responds to each requested modification This letter memo is optional but it often helps to provide context for the review of your revisions 7 Attach a revised document or add new project documents to the new package by following the instructions for adding new documents in the Designer section of this document 8 The person preparing the response and or the PI should sign the package in compliance with the package signing instructions 9 Submit the documents to the IRB by following the Submit this Package instructions and designating the submission type as a Revision 5 Who is required to sign the package e Ata minimum RCRMC s IRB requires that the principal investigator PI sign each package before it is submitted See above for more information about how to sign a package e If you are a student resident or fellow it will be necessary for your faculty advisor to sign the package If the principal investigator is different than the faculty advisor on a student resident or fellow project both the PI and the faculty advisor must sign the package e Ifyou are not a RCRMC affiliate it will be necessary for the RCRMC sponsor to sign the package before it is submitted e A signature on behalf of the PI should be used only in the rare event when the PI cannot access IRBNet 6 What is the difference b
16. ocuments from the Riverside County Regional Medical Center documents library step 1 Be sure to select the Riverside County Regional MC RCRMC in the select a library field The documents library contains informational how to documents forms templates and checklists Download any document that you will use in your submission Documents downloaded from the library should be saved to your computer completed resaved and then uploaded into IRBNet Transaction Form New Project Required Documents e Proposal see Proposal Primer for instructions on preparation e IRB Application e Research Determination Worksheet Mandatory for non faculty only e Operational Academic Consideration Form e Conflict of Interest and Financial Disclosure e CITI or NIH Protecting Human Research Participants training Completion Certificate Additional Documents if e HIPPA Waiver applicable e Authorization to Use or Disclose Personal Health Information PHI e Consent Form in English and Spanish e Copy of Experimental Subject s Bill of Rights e Single Case Report Consent e Line Item Budget including all funding if funding is applied for or received You may also need to include additional relevant documents such as o Recruitment materials e g flyers posters brochures letters emails o Measurement tools g surveys interview questions o Informed Assent C Parental Guardian Permission only applicable if including childr
17. rms to meet the requirements of their local Board You will be able to monitor the progress of this project at every local site The other local Principal Investigators will also be able to monitor the progress of this project at every local site including your own e Transfer Transfer your ownership of this project to another user In doing so you will relinquish all access to this project and the designated user will be granted Full access If you are a Riverside County Regional Medical Center affiliated faculty or staff member non student resident or fellow who is also the PI on this project and you are not required to obtain signatures from your department chair you are not required to share the project with anyone else However you may choose to share the project with others if you wish e g Co PI other personnel department chair If you are not the PI for this project it will be necessary for you to share the project with the PI If you are unaffiliated with Riverside County Regional Medical Center it will be necessary for you to share the project with the Riverside County Regional Medical Center sponsor for your project Ifyou are a RCRMC student resident or fellow working on a project it will be necessary for you to share the project with your faculty advisor If your faculty advisor is different than the PI for your project you will need to share the project with both your faculty advisor and the PI of the project e
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