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Intro to eIRB

1. Richard Ing 6 23 2011 4 07 PM Jump To Dept App Please respond to the following reviewer notes Cy Response Reguired Click here to respond 3 Respond to each change requested lt lt Back Save Exit Hide Show Errors Print Jump T 1 3 Human Subjects Determination w Reviewer Notes Fiter by O Co Type Reviewer S Modified oept Department Change Request Richard Ing 6 23 2011 4 07 PM Dept App Please respond to the following reviewer notes hf Response Reguired4Click here to respond_J Be sure to Save before you Exit the SmartForm 5 When the Study Staff have completed all of the requests in the application workspace click the Submit Requested Revisions or Information and complete the submission attaching any requested documents elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 16 Pending Ancillary Approvals History Attachments Pre Review Status Rewewer Notes Change Log No Pending Ancillary Approvals Activity Author foept Department Requests Revisions Or Information Ing Dept App Richa My Activities Notify Team Members to EN 1 Reviewer Note Logged test Agree to Participate Frrr Submitted Requested Revisions or Information Simms Rebecca er Submit Requested ae Revisions or Information 0 Changes Logged Just testing oer Withdraw study foepe Department Requests Revisions Or Information Ing Dept App Richa After you have su
2. Applications for Research Compliance PORTAL eIRB Study Team Manual This guide serves to aid the study team become familiar with the basic functions of the elRB module of the ARC system e RB Study Team User s Manual Page 2 Table of Contents VV GNC 1 Fa RG ccc cecec cc ection EEEE AE ae eveceteceyscenyanceceneeadsccessccesetevaceciavsecrsesenacess 3 ACCOUNTS isanne EEEE ESE 3 NOWA OME CTS CUI O a A OT A 3 KOO Miene genta cela aa nene a ediie ceajaniveatratekonmeaby ustnadueesd nares seansnties snayuauanatvcnniveananhs 4 Forgot Your User Name or Password cccssssesseseseseseseseseescsescaeaeaeasasaeaessaseseseseeeseneneneneneneneneneneneneean 4 ACCOUN CanEs E ee ee ee 5 Navigatio iissa ESE EEA a EEEa SS 6 EOC Di E S eens tai 6 My Home 08 6 querer er rere ee ore ee ere ee A E 6 0 cee re eee ee ee ene ee ee ee ee eee 7 Navea e ol eee eee ne ee EE 8 WDE k o E E E A sees cscan N A T 8 IRB Approved Studies and COI Tabs s s ssssssssssnssnssrrnnnsnssnssnnnnnnnsnnsnnnnnnnnnnnnnnnnnnonnnnnnnnnnnnnnnnnnnnennnnnna 9 Application Workspace scssssssssssssssecscsscsccsesssssssssssssesacscesesessssssessssececasacsesesesesessseeesesasasasaesesesessseseeesasas 9 Createa NOW SUY seiccscicccstctesccnccedsccsccerecncesetcecesacctescaseceecucsececnsuseccieuedsGesevansesoccstconscenscosseskteveccansoae 11 NVM MI WI VAT Or asec ete reece cea ee E EAEE EEEE EES teres EE AEE 11 Aa ne DOCU AS aeie EE E 12 Ma o DOW Er OT nei E eee 12 Comp
3. 01 AM i ce ProQ0000083 _Frotocol Fri Nov5 11 5 2010 Study Pre Submissio 11 5 2010 Conflict of Interest 13 34 58 EDT 2010 1 39 PM 1 35 PM ig New COT Disclosure c Pro00000227 Protocol Tue Mar 6 3 6 2012 Study Pre Submissio 3 6 2012 10 34 30 EST 2012 10 34 AM 10 34 AM When you are in other sections of the ARC system you can easily get back to your homepage by clicking the link to My Home UNIVERSITY OF SOUTH FLORIDA Home Sandbox IRB Studies Folder for Richard Dept Richard Ing Dept App Roles A person can have multiple Roles in ARC such as Principal Investigator PI Co Investigator Study Coordinator Department Approver IRB Committee member etc Different Roles provide access to different applications information and activities A person with the PI role will also have the role capabilities of Co Investigator Study Coordinator and Study Staff Your current Role will be displayed in the red banner at the top of the column on the left side of your Folder Your current role will be Bold in the listing of your available Roles If you have more than one role each time you log in be sure that the correct role is selected If the desired role is not selected click on the role you need elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 8 Folder for Richard Arm Comm Chair Welcome to your Personal Page the starting point for all My Roles Committee Chair Inb
4. To menu WARNING After you enter or edit data on a screen click Save before using Jump To The Jump To menu does not save Save Exit Hide Show Errors Print Jump To 1 3 Human Subjects Determination 1 Study Personnel amp Funding 1 1 Study Identification a 1 2 IRB Researcher Training Records Human Subjects Research Determination Please provide answers to the following questions such that the IRB may make th YOu are proposing are or are not humans subject research 1 3a Research Determination 1 3 Human Subjects Determination 1 3b Human Participant Determination 131 le this research 1 3c Human Subjects Determination Cont Yes ONo Clear 1 4 Study Information 71 5 Funding Sources Attaching Documents Attach documents such as the protocol and consent forms by using the Add button associated with the relevant question in the SmartForm Before attaching a document be sure you have named it using an accurate description Example Informed Consent Spanish StudyO00000342 Hide Show Errors Within a SmartForm use this tool to gauge your progress with the application In the menu bar click Hide Show Errors to list the required fields that need to be completed elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 13 Save Exit Hide Show Errorg Print JumpTo 1 1 Study Identification S Error Warning Messages Message Field Mame Jump To amp This
5. is a required field therefore you must provide a value 1 3a 1 Systematic Investigation Yes No 1 3a Research Determination amp This is a required field therefore you must provide a value 1 3a 2 Generalizable Knowledge Yes No 1 3a Research Determination Click the link again to hide Error Warning Messages Completion and Submission A Two Part Process 1 Complete the application The PI and Study Staff create and complete the application The application remains in your Inbox 2 Submit the application The PI submits the completed application Submission moves the application from your Inbox to the next State Part 1 Complete the Application When an application is created it starts out in the Pre Submission State In this State all Study Team members can work on the application attach documents and save changes To prepare a completed application for submission to the IRB 1 Inthe study Workspace under My Activities click Notify Team Members to Agree to Participate 1 Click OK to send notice to team members My Activities p r Notify Team Members to Agree to Participate PI submit Study PI Withdraw Study 2 When they receive the notice all Study Staff must agree to participate and must respond to the Conflict of Interest questions Part 2 Submit the Application Only the Principal Investigator for the study can submit the initial study After the initial application is submitted the s
6. of your homepage Study Staff Page for Rebecca Simms iid Welcome to your Personal Page the starting point for all interactions with this site Note the following y Roles Study Staff Inbox Items appearing here require immediate action by you to speed your submission through the review process Click on link to access an item Monitor Check the progress of your submissions using the other tabs Items under these tabs do not require any Quick Links action by you Division of Research Integrity amp Compliance Approved Studies Profile Col Human Subjects lestays all items which require action by the study team Click on links for more information Er vewine sway ig Convert Paper Study Filter by ID Advanced The IRB Study Number is assigned automatically the first time you save the study or after you complete the first page of the application and click Continue Working with Smart Forms All applications in e RB use SmartForms which present only those questions that are relevant to your study It is important that you respond to each question displayed on the SmartForms Required fields are marked with a red asterisk You can answer text questions by typing directly into the text box or by pasting in text from other documents Add function allows you to attach relevant documents or select your answer from a pre populated list depending on the question Navigation controls are located in the navigation bar at
7. university in Florida which has its Human Research Protection Program accredited by 3 AAHRPP Need Help Forgot Password Forgot User Name Division of Research Integrity amp Compliance ARC Help Desk eIRB eCOI elACUC 813 974 2880 E Mail rsch arc usf edu Mail 12901 Bruce B Downs Blvd MDC35 Tampa FL 33612 4799 Copyright 2011 University of South Florida Al rights reserved Forgot Your User Name or Password If you ever forget your account credentials you can have them emailed to you on the ARC Home page 1 The Forgot Password and Forgot User Name options are available under Need Help elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 5 UNIVERSITY OF SOUTH FLORIDA Institutional Animal Care Need an account and Use Committee Home Register Here Research Conflict of Interest 7 Welcome The Division of Research Integrity amp Compliance administers key research Institutional Review Board related assurance and compliance programs required by federal and state agencies Have an account What s New and programs for the conduct of research at USF This site enables the division to manage all aspects of the Institutional Review Board process Training Materials User Name Regulation and Guidance Full AAHRPP Accreditation With this prestigious distinction USF joins an elite Password group of top research universities and becomes the first AAHRPP accredited Contac
8. FL 33612 4799 Copyright 2011 University of South Florida Al rights reserved 3 Complete the required fields and provide your USF Net ID Employee ID and USF or affiliate email address 4 Select all relevant roles such as Study Staff PI Department Approver etc 5 Click Register elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 4 6 Within two business days your new account will be activated and you will receive an e mail containing your account information i e User Name amp Temporary Password Log In 1 Type your User Name in the login section on the right side of the ARC screen 2 Type in your Password 3 Click Log In UNIVERSITY OF SOUTH FLORIDA atc Institutional Animal Care Need an account and Use Committee Home Register Here Research Conflict of Interest re Welcome The Division of Research Integrity amp Compliance administers key research Institutional Review Board related assurance and compliance programs required by federal and state agencies Have an account What s New and programs for the conduct of research at USF This site enables the division to manage all aspects of the Institutional Review Board process 4 Training Materials User Name Regulation and Guidance Full AAHRPP Accreditation With this prestigious distinction USF joins an elite 2 Password group of top research universities and becomes the first AAHRPP accredited Contact Us
9. Manual Page 9 2 Name column Displays the name of applications in your Inbox Clicking the name will bring up that application s workspace 3 Type column Displays the type of application Study amendment etc 4 State column Displays where the application is in the IRB process Once you have completed the required activities the application is moved electronically from one respective Inbox to the next according to whose attention it requires If an application is not in your Inbox it s someone else s turn to work on it If an item is in your Inbox it still requires your attention IRB Approved Studies and COI Tabs The IRB tab lists all applications with which you are associated regardless of the state In the IRB tab you can monitor the State of all of your applications You can view applications under the IRB tab by clicking the application Name The Approved Studies tab lists all of your studies that have been approved by the IRB The COI tab lists all of your conflict of interest applications Application Workspace Work on an application begins in the application Workspace which is like a home page for the application Open an application Workspace by clicking on its Name in your Inbox The application Workspace provides e information about the application e links to specific sections and documents related to the application e buttons to initiate Activities and move the application to the next step in the IRB
10. age click the Account tab Type in your old password your new password and your new password again in their respective boxes Click Apply elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 6 After receiving your username and a temporary password you can log in to the ARC system Navigation Log In 1 Type your User Name in the login section on the right side of the ARC screen 2 Type in your Password 3 Click Log In UNIVERSITY OF al SOUTH FLORIDA What s New Need an account Home Institutional Review Board Register Here Institutional Animal Care Welcome The Division of Research Integrity amp Compliance administers key and Use Committee research elated assurance and compliance programs required by federal and Have an account Research Conflict of Interest state agencies and programs for the conduct of research at USF l This site enables the division to manage all aspects of the Institutional Review Board T User Name ARC Training Materials process ser Name Contact Us 2 Password Full AAHRPP Accreditation With this prestigious distinction USF joins an elite group of top research universities and becomes the first AAHRPP 3 Log In accredited university in Florida which has its Human Research Protection Program accredited by AAHRPP Need Help Forgot Password Forgot User Name Division of Research Integrity t Compliance ARC Help Desk eIRB eCOl elACUC 813 974 2880 E Mai
11. ator Rebecca Simms Study Coordinator Rebecca Simms Expiration Date 6 10 2012 IRB Letter IRB Letter for Study Pro00000133 0 01 Funding Sources Non Sponsored No Funding Attachments and Informed Consent Documents All attachments to the study application including the approved consent forms can be viewed in the study Workspace under the Attachments tab After IRB approval all attachment to the approved study can be viewed by following these steps 1 In your Folder My Home click the Approved Studies tab see illustration 1 above 2 Inthe Approved Studies folder click the study name see 2 above 3 In the study workspace click the Attachments tab see 3 below A list of all attachments will be displayed 3 pet Amendments Continuing Reviews Reportable Events f Attachments Change Log Activity Author Activity Date IRB Letter Sent to Study Team Richard Arm Comm Chair 8 1 2009 5 05 PM EDT tres IRB Drafted Letter To FI Orlando Max IRB Staff a 1 2009 5 00 PM EDT e The Approved Consent Forms section will list all of the consent forms approved for use in the consent process These documents will be read only pdf files e The remainder of this screen displays each question in the SmartForm that prompts for a document to be uploaded This includes unstamped consent forms in MS Word format should there be a future need to make changes Scroll down to quickly locate any attachment to the application Creating Rep
12. bmitted your response the application will no longer be displayed in your Inbox because it has moved to the reviewer for further review However it will be listed under the IRB tab in your Folder My Home where you can view a read only copy Approval Letter When the IRB has approved your study you will receive an e mail notification of approval The approval letter will also be available in the study Workspace To view the approval letter in e RB 1 In your Folder My Home click the Approved Studies tab IRB Approved Studies J Templates Profle Audits Col Displays all ttems which require action by the study team Click on links for more information piter by Name 3 Ses Advanced Name Date Modified Type Owner state Last State Change Ge test 6 23 2011 4 08 Study Changes Requested By 6 23 2011 4 06 PM Department Reviewer PM ce tiredionwge 6 23 2011 2 52 Study Fre Submission 6 23 2011 2 38 PM PM 2 Inthe Approved Studies folder click the study name Inbox IRE EE Templates Profle Audits COI ID Name Date Modified State Pro00000141 Afiliate Review Test 6 23 2011 12 45 PM Approved Pro00000133 6 22 2011 3 39 PM Approved 3 In the study workspace the summary panel will now display a link to view the Letter of Approval Click on file next to IRB letter 3 elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 17 Study Test Pro00000133 Description Test Principal Investig
13. completed The summary panel displays information about this study The information changes when a study becomes active IRB Study Number also referred to as the Pro Edit Study button opens the application SmartForm for editing while the study is in your study team s Inbox only When the application is not in your Inbox the button is View Study and will provide read only access Printer Version button opens all of the relevant SmartForm screens in one easy to print window The left column lists actions and Activities that can be performed on the study in its Current State The list will vary depending on the Current State and role The legend on each button indicates which Role i e Pl only or any study team member can perform this activity Click the button link to open the Activity screen The History tab lists chronologically all actions that have been performed on the study Click the Activity name in the listed History to view details The Attachments tab lists all documents that have been uploaded for this application Successive versions are archived automatically so that you have access to the most currently approved versions i e protocol informed consent advertisement etc elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 11 Create a New Study In the role of Study Staff you can create a new study Initial Application by clicking the New Study button in the column on the left side
14. l rsch arc usf edu Mail 12901 Bruce B Downs Mwd MDC35 Tampa FL 33612 4799 Copyright 2011 University of South Florida All rights reserved My Home Folder After logging in the screen displays your Folder which is like a personal home page Here you will be able to view and manage those studies relevant to your Role elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 7 UNIVERSITY OF A Rebecca Simms My Home Logoff SOUTH FLORIDA A Home Sandbox IRB Studies IACUC Study Staff Page for Rebecca Simms Mv Rol Welcome to your Personal Page the starting point for all interactions with this site Note the following y Roles Study Staff Inbox Items appearing here require immediate action by you ta speed your submission through the review process Click on link to access an item Monitor Check the progress of your submissions using the other tabs Items under these tabs do not require any Quick Links action by you Division of Research Integrity amp Compliance IRBs IACUC Approved Studies Profle COl Human Subjects Displays all items which require action by the study team Click on links for more information EJ New IRB Study ig Convert Paper Study Filter by ID ves Advanced ID Name Date Modified Type State Last State Animal Subjects Change F ProQ000016 _Frotocol Fri Juli 7 1 2011 Study Fre Submissiol TH1 2014 New tacuc Study 10 04 11 EDT 2011 10 01 AM 10
15. letion and Submission A Two Part ProCeSS s sssnssnsunnnnnnnnnnnnunnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 13 Part 1 Complete Ne Ap Pl CAGON wvcsesstcscctdesesesescscesccvsevsstaratsrschovsecsseuebeaeeesasensieverenarterrneastietneneewescdenete 13 Part 2 Submit the Application eseeseeeessssssesesseseseseeeessssssessseesesesseseessssesesessesenannaean 13 IRB REVIEW and ADDI OV al vscsscsisecsetscesccssecsscastecaccustenxecainoescseeneennceuistancuelenencedsacesctonstaanesiatesemiaubarnouss 14 Propre S 91 dere a0 NS aea E enter tee rer are eee eee tan een ee ere ee 14 H Oy GOT aen mer errr steerer rtrrret tier errr nee rere E ers rete rer E emer errr terren Creer errr rrr 14 Respond to Requests for Revisions Or Information hu 15 7Ay0 0 044621100 a ere renner er eer eat eee a eee eres 16 Attachments and Informed Consent Documents s srssrssrsresresrssrssrnnennsnssnnnnnnnnnnnnnnnnnnonnsnnnnennnnnns 17 Creating Reportable Events Amendments amp Continuing Reviews sssssssssnssunnnnnnnnnnnnnnnns 17 New ECL ONS ei canst aucanauias tondunnauacuiees EEEE AAE EAEE NEEE 18 elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 3 Welcome to ARC Our on line ARC system streamlines the process of submitting approving tracking and managing elRB eCOl and elACUC applications ARC is available via Internet connection 24 hours a day 7 days a week The ARC HelpDesk is available during regular bu
16. ortable Events Amendments amp Continuing Reviews After a study has IRB approval you can create a study sub project a new reportable event amendment or continuing review application In the study Workspace click the relevant activity button and then complete the SmartForm application that is displayed elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 18 Create 1 New Reportable Event C New Amendment Eel New Continuing Review Workspaces for study sub projects are similar to the study Workspace After a reportable event amendment or continuing review has been created and saved it can be accessed in your Inbox until you submit it After it has been submitted it will be routed to the IRB and can be viewed in the study Workspace under the respective tab Amendments Continuing Reviews Reportable Events If a previous amendment for this study is pending IRB approval the New Amendment button will not be displayed until after the previous amendment is approved If you have submitted a Continuing Review CR that is now pending review and you need to amend the study you will need to either e wait until the CR is processed or e withdraw the CR and submit the Amendment and then re submit the CR after the Amendment is approved New Terms e Modification Request Amendment e Progress Report Continuing Review e Determination Not Human Subjects Research e Informa
17. ox items appearing here required immediate act Comm tee Memb on link to process an item ane n Monitor the progress of your submissions using the Study Staff Navigation Tabs The central area of your Folder My Home provides a row of navigation tabs Inbox IRB IACUC Approved Studies Profile Col WDisplays all tems which require action by the study team Click on links for more information Inbox Tab Inbox lists all applications studies amendments continuing reviews and reportable events that require action by you or other staff on your study team in your current Role Below is an example of your Inbox IRB Approved Studies Templates Profile Audits Col Displays all items which require action by the study team Click on links for more information Name 2 I Date Modified Type 3 Owner State 4 Last State Change Ge testing coord withdraw 6 30 2011 3 46 Study Pre Submission 6 30 2011 9 40 PM AM ge Amendment 7 for IRB 6 30 2011 2 22 Amendment Max IRB Pre Submission 6 30 2011 2 11 Study Pro00000011 PM Staff PM Orlando ge Amendment 4 for IRB 6 30 2011 11 52 Amendment Max IRB Pre Submission 6 30 2011 11 51 Study Pro00000133 AM Staff AM Orlando qe Agree to participate testing 6 30 2011 10 35 Study Fre Submission 6 30 2011 10 35 AM AM Key to the Inbox page 1 The Inbox tab Displays all applications requiring attention by the study team elRB Study Team User Manual 8 20 2012 e lRB Study Team User s
18. process these buttons are only available to you when the application is in your Inbox e history of all activities performed on the application After a study has been approved tabs for Adverse Events Amendments and Continuing Reviews are displayed next to the History tab in the study workspace Below is an example of a study Workspace screen elRB Study Team User Manual 8 20 2012 e RB Study Team User s Manual Page 10 UNIVERSITY OF Q Rebecca Simms My Home Logoff SOUTH FLORIDA al F A Home Sandbox IACUC 2 3 Current State 1 Study _Protocol Fri Jul 1 10 01 11 EDT 2011 Pro00000167 ea E arsuwa 4 Principal Investigator Rebecca Simms Study Coordinator Carmen Alverado Study Coord Study Type Review Type Printer version Funding Sources There are no items to display Ee view SmartForm Progress My Activities 6 Notify Team Members to l Agree to Participate PI Submit Study 8 er Withdraw Study ss Copy Study Attachments Change Log This area shows instructions and questions and important notifications regarding this Study Activity Author Activity Date aad F Created Study Simms Rebecca 7 1 2011 10 01 AM EDT lss Edit Guest List ss Upload Team Member CV cs Upload Team Member Education Certification Key to the study Workspace screen 1 Current State indicates the stage in the IRB review process for this study This changes as Activities are
19. siness hours at 813 974 2880 and by email at RSCH arc usf edu Accounts In order to create and submit applications in ARC you will first need to obtain an account by submitting a new user registration request New Account Registration To open your new ARC account 1 Goto the ARC Web Site https ARC research usf edu prod 2 Click Register Here on the right hand side of the page UNIVERSITY OF SOUTH FLORIDA Institutional Animal Care Need an account and Use Committee Home Register Here Research Conflict of Interest Welcome The Division of Research Integrity amp Compliance administers key research Institutional Review Board related assurance and compliance programs required by federal and state agencies Have an account What s New and programs for the conduct of research at USF This site enables the division to manage all aspects of the Institutional Review Board process Training Materials User Name Regulation and Guidance Full AAHRPP Accreditation With this prestigious distinction USF joins an elite Password group of top research universities and becomes the first AAHRPP accredited Contact Us university in Florida which has its Human Research Protection Program accredited by Log In AAHRPP Need Help Forgot Password Forgot User Name Division of Research Integrity amp Compliance ARC Help Desk eIRB eCOI ElACUC 813 974 2880 E Mail rsch arc usf edu Mail 12901 Bruce B Downs Blvd MDC35 Tampa
20. t Us university in Florida which has its Human Research Protection Program accredited by Log In AAHRPP Need Help Forgot Password Forgot User Name Division of Research Integrity amp Compliance ARC Help Desk eIRB eCOI elACUC 813 974 2880 E Mail rsch arc usf edu Mail 12901 Bruce B Downs Blvd MDC35 Tampa FL 33612 4799 Copyright 2011 University of South Florida Al rights reserved 1 If you select Forgot user name you will be prompted to confirm your email address Once confirmed your user name will be emailed to you 2 If you select Forgot password you will be prompted to confirm your user name and email address Once confirmed a new temporary password will be emailed to you Upon log in you will be required to change your password If you have forgotten both your user name and your password select Forgot user name first as it only requires your primary email address After receiving your username you can select Forgot password Account Changes It is important to keep your account information current To make changes to your account click your name in the upper right hand corner of your screen to open your account properties Rebecca Simms My He ne Then make the necessary changes and click Apply Note For changes to your department affiliation and assigned roles you will need to contact the helpdesk To change your password click on your name as described above On your Account p
21. the top and bottom of each page Use the Continue and Back buttons to move to the next or last viewed screen UNIVERSITY OF Edit study Prod0000127 SOUTH FLORIDA j lt Back Save Exit Hide Show Errors Print Jump To 1 1 Study Mentification Se ee Use the SmartForm navigation controls instead of the controls in the browser bar e g Internet Explorer Firefox Chrome Safari Opera E Home Microsoft Internet Explorer provided by Information Technology Services x DK hitps arc research usf edu Prod Rooms DisplayPages LayoutInitial Container com a XxX elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 12 Save your application by clicking Save or Continue WARNING The Back button does not save changes After you enter or edit data ona screen click Save before going Back Use Exit to close the application and return to that application s Workspace WARNING Always Save before exiting Each section and question is numbered for easy navigation and reference Numbering is consistent through all SmartForm applications however remember that only the relevant questions for each specific study are displayed Once new or revised data on a page has been saved you can navigate directly to other sections and questions by using the Jump To drop down menu The title of the displayed page will be red Items not relevant to this study will appear gray in the Jump
22. tion Reports and Adverse Events Reportable Events elRB Study Team User Manual 8 20 2012
23. tudy coordinator or secondary coordinator regulatory specialist can submit additional applications requested revisions amendments reportable events and continuing reviews 1 To submit the initial study to the IRB the PI will open the application Workspace and click Submit Study under My Activities elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 14 My Activities fe Notity Team Members to nate fpr Submit Study PI Withdraw Study 2 ARC will run a final validation check on the entire application before submission If there are any required fields that have been left blank or staff who have not agreed to participate they will be indicated and your application will not be submitted The application must be error free before it can be submitted 3 After the application has been submitted it moves from the Pre Submission State to the next State Once submitted it cannot be edited unless changes are requested by a reviewer and it is returned to the Study Team Inbox 4 After submission required Department or Affiliate reviews are conducted before the study is routed to the IRB for review IRB Review and Approval Progress Notifications e RB automatically sends e mail notifications to the study team when significant events occur in the review process Be sure to keep your e mail address current in the ARC system To change your e mail address see Account Changes on page 5 The S
24. tudy team will receive e mail notifications at the following times e Requests for information and changes to the application e Official actions from the IRB i e when the application is scheduled for a board meeting once an application is approved disapproved etc e When studies are due for Continuing Review You can also check the progress of your application at any time by checking the History log History Log The History tab in the study Workspace displays the permanent history log of all actions that have been performed on the study It lists chronologically those actions which you have permission to view Click an Activity name in the History log to view its details elRB Study Team User Manual 8 20 2012 e lRB Study Team User s Manual Page 15 When an application is approved ARC creates a Project Snapshot that is a permanent archive of the project and all its documents Snapshots are stored in the history log and can be accessed there Respond to Requests for Revisions or Information 1 In your Folder Inbox click the study Name to open the application workspace 2 Under the Reviewer Notes tab you will find all notes that have been added to the study Each note provides a Jump To link that will take you to the page where the requested change needs to be made History Attachments Pre Review Status Reviewer Notes Change Lag Reviewer Checklists Filter by Advanced Reviewer Modified foept Department Change

Intro to eIRB

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