Study Team User`s Manual - USF Research & Innovation
Contents
1. y UNIVERSITY OF SOUTH FLORIDA Study Team User s Manual October 2009 eiRB Study Team User s Manual Page 2 Table of Contents VV CRC ONIG CO CIRI seccccescceseacacecsscsacetascascasctssacsussatassenscsacetassanesas snacussetsesenedsacstastanecsedtsacesesetsessseesaesiaseses 2 PCC OUINGG sis ceeisesside cia scts etude ceiss awiassuccsceciasotsededuswcscuesavaseeausecciasebsddedusedeceesabeddecusecesUessbiedodetaddedcaeeestavesieteads 3 TNO WCC OUI ROS 0 A010 00 praca cress ce cinn save sre ceee coeds T as ane E E E 3 ACCOUNT CPAN OS sare EE E E E aoavsdseaiintactaeacdactaasnexclpeaesas 3 Pa SO E E EE E E EE 4 Mavi ooien E E A S 4 LO De E E A E E E E E teneraesaaisenteeaecenesase es 4 Forgot Your User Name or Password ccccccscccccccceeesseseeeccceeeeeaeeseeeeceeeeesaaaeseeeceeseseaaaganees 4 IVA Homne OC eea E E E A 5 TONS A EE A E E E A E E E eases J aae OG a E EE E E A E E E E 6 MEO TiD E tl tisualacce tee otesatatanenatee i oaseesanehacenstesaieaiat 6 IRD Tas agete ese cee toseeesoaesevasneeenteaseosevacnessessesscvasecyeasaadensesacteaseesdeegeeyastuse lt aeacansereatanseosseassecens 7 APPEAU WOK Pa eae a A E 7 CEAN S a E E 9 Working with Smart FOrmS seeccccsssscccceccccssscsccecccocssscsecccccccossseccccccccssssececccocsssssceccosssseceecccosssssccececoss 9 ACNE OCU O S sates a E A E E E E E EE N 11 PHC SNOW ETO ea aa A E E E R E EES 11 Completion and Submission A Two Part Process cc2. 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 Modification Request Amendment Progress Report Continuing Review Determination Not Human Subjects Research Information Reports and Adverse Events Reportable Events elRB Study Team User Manual 2009 10 12
3. 1 HIPAA Waiver or Alteration Minimal Risk to Privacy HIPAA Waiver or Alteration PHI Source Cont Description 9 1b 2 Please indicate which of the following direct identifiers will b vour obroposed research from the participant or the particion elRB Study Team User Manual 2009 10 12 eiRB Study Team User s Manual Page 11 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 For example Informed Consent Spanish Study000000342 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 Save Exit Hide Show Errors JPrint Jump To 1 1 Study identification we Error Warning Messages Message Field Name Jump To amp This is a required field therefore you must provide a Inclusion Critena 6 1 Study Population Cont value amp This is a required field therefore you must provide a Exclusion Criteria 6 1 Study Population Cont value Click the link again to toggle off 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 yo
4. 0000 Operation Launch Study D 9 11 2009 9 36 AM Department Review ProQ0000018 Board Member Demonstration 9 10 2009 3 43 PM IRB Staff Review Pro00000005 Operation Launch Study B 9 10 2009 9 03 AM Certified Exempt Pro00000017 Friday Test Study 6 26 2009 1 30 PM Changes Requested By IRB Staff ProQ0000015 Operation Study A tlp 20 2009 12 52 In Expedited Review Awaiting PM Correspondence ProQ0000006 Operation Launch Study C o 26 2009 2 51 PM Awaiting Signature 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 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 elRB Study Team User Manual 2009 10 12 elRB Study Team User s Manual Page 8 Below is an example of a study Workspace screen ald Se 2 Rebecca Simms Fl My Home Logoff ai SOUTH FLORIDA 2 3 Current State 1 Study Full Board Drug Study Pro00000130 D
5. 9 9 05 study Pre Submission 6 9 2009 11 53 AM AM 2 In the Approved Studies folder click the study name Inbox IRB WAE Templates Profle Audits Filter by ID Advanced ID Name Date Modified State ProQ0000297 Resolution of a Phytobezoar with Aldoph s Meat Tenderizer 8 3 2009 3 16 PM Approved ProO0000106 NStudy J 8 1 2009 5 06 PM Certified Exempt elRB Study Team User Manual 2009 10 12 eiRB Study Team User s Manual Page 15 3 Inthe study workspace the summary panel will now display a link to view the Letter of Approval Click on View 3 Study NStudy Pro00000106 Description studying Nstudies for n reasons Principal Investigator Rebecca Simms FI Study Coordinator Carmen Alverado Study Coord Expiration Date F 23 2010 Letter of Approval 3 Funding Sources Internally Funded Investigators Department 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 In the 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 Amendments Continuing Review
6. age Here you will be able to view and manage those studies relevant to your Role US J UNIVERSITY OF SOUTH FLORIDA Home IRB Studies Rebecca Simms Pl My Home Logoff Study Staff Folder for Rebecca PI Welcome to your Personal Page the starting point for all interactions with this site Note the following My Roles Study Staff Inbox items appearing here required immediate action by you to speed your submission through the review process Click on link to process an item Monitor the progress of your submissions using the other tabs Items on these tabs do not require any action by Quick Links you Consent Forms IRB Approved Studies Templates Profle Audits Create Displays all tems which require action by the study team Click on links for more information EJ New Study Filter by Name x Advanced Name Date Modified Type Owner State Last State Change ce h 9 22 2009 9 43 Study Fre Submission 9 16 2009 1 16 AM PM ce Amendment 1 for IRB 9 10 2009 9 05 Amendment Max IRB Pre Submission 9 10 2009 9 03 study Pra00000005 AM Staff AM Orlando Ge Friday Test Study 9 4 2009 1 07 study Pre Submission 6 25 2009 3 03 PM PM When you are in other sections of the elRB system you can easily get back to your Folder by clicking the link to My Home UNIVERSITY OF B Rebecca 5 s PI My Home L SOUTH FLORIDA ebecca Simms PIf y ome Logoff Home IRB Studies Roles A pers
7. bmission 9 16 2009 1 16 AM PM Ge Amendment 1 for IRB 9 10 2009 9 05 Amendment Max IRB Pre Submission 9 10 2009 9 03 study Pro00000005 AM staff AM Orlando ce Friday Test Study 9 4 2009 1 07 study Pre Submission 25 2009 3 03 PM PM You can access an application listed in your Inbox by clicking the application Name Once you have completed the required activities the application is moved electronically from one respective Inbox to the next according to who needs to work on it next If an application isn t in your Inbox it s someone else s turn to work on it If an item is still in your Inbox it still requires your attention elRB Study Team User Manual 2009 10 12 eiRB Study Team User s Manual Page 7 IRB Tab The IRB tab lists all applications with which you are associated regardless of the state they are in In the IRB tab you can monitor the State of any application you re associated with You can view applications under the IRB tab by clicking the application Name IRB j Approved Studies Templates Profle Audits Displays IRB related items you are associated with but do not require any action py the study team at this time ProQ0000020 Show it all 9 16 2009 1 21 PM Department Review Pro00000009 Operation Launch Study F 9 15 2009 12 33 Assigned To IRB Meeting PM ProQ0Q000001 Full Board Study hrz 9 15 2009 11 01 Assigned To IRB Meeting AM Pro00000019 Operation Launch Study G 9 14 2009 3 29 PM IRB Assignment ProQQ0
8. ccccccccccecccceeeseseeeceeeeeeseeaeneeeeeeeeeeaaas 11 Pant l Complete he Fup Catt OM esnin e EEEN 11 Part 2 Sia We App AMON aae A E E EENT 12 Progress NOUMICAMOUS seserseiiesni a anea iaia a haesen aniei 12 HEO GO a E E E E E 13 Respond to Requests for Revisions or Information ssseeensssessseseeresssssseeerrsssssssseerssssssssee 13 APPO AU ICT e E E E EE E E EE E EAR 14 Attachments and Informed Consent Documents 2 0 0 0 cecccccccccccceeseeseeeeeeceeeaeeseeeceeeeeeeaaeenees 15 Creating Reportable Events Amendments amp Continuing Reviews cccccccccccccccccccccccccceees 16 ING W TONS en E E E E S 16 Welcome to elRB Our on line elRB system streamlines the process of submitting approving tracking and managing IRB applications elRB is available via Internet connection 24 hours a day 7 days a week The elRB HelpDesk is available during regular business hours at 813 974 2880 elRB Study Team User Manual 2009 10 12 eiRB Study Team User s Manual Page 3 Accounts New Account Registration To open your new elRB account 1 Go to the elRB Web Site https eirb research usf edu prod 2 Click Register Here on the right hand side of the page USF Rese TY OF fas S ogin SOUTH FLORIDA Home Institutional Review Board What s New Home Register Here General Information Welcome The Division of Research Integrity amp Compliance administers key research related Have an account Re
9. edited university in Florida forth when you received your account which has its Human Research Protection Program accredited by AAHRPP Division of Research Integrity amp Compliance Mail 12901 Broce B Downs Blvd MDC35 Tampa FL 33612 4799 Phone 613 9745038 Fax 813 9745618 Copyright amp 2008 University of South Florida All rights reserved Direct questions of comment about this Web site to jamaldifiresearch usiedu Last updated July 1 2008 Forgot Your User Name or Password 1 Click Forgot password or Forgot user name Need an account Register Here Home Welcome The Division of Research Ii Compliance administers key research 1 assurance and compliance programs requhed federal and state agencies and programs for conduct of research at USF This site enables the division to manage all aspects of the Institutional Review Board process Have an account Full AAHRPP Accreditation With this prestigious distinction USF joins an elite group After signing into this site you are of top research universities and becomes fhe bound by the terms and conditions set first AAHRPP accredited university in Florida forth when you received your account 2 The respective information will be sent to your e mail of record elRB Study Team User Manual 2009 10 12 eiRB Study Team User s Manual Page 5 My Home Folder After logging in the screen displays your Folder which is like a personal home p
10. ending on the Current State 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 2009 10 12 eiRB Study Team User s Manual Page 9 Create a New Study In the role of PI or Study Staff you can create a new study Initial Application by clicking the New Study button 1 in the column on the left side of your Folder My Home Study Staff Folder for Rebecca PI Welcome to your Personal Page the starting point for all interactions with this My Roles Study Staff Inbox items appearing here required immediate action by you to speed on link to process an item e Monitor the progress of your submissions using the other tabs Items or Quick Links ConsentFome 2 Inbox IRB Bile E Profle Audits Templates Name If you want to create a new informed consent document open an informed consent template by clicking the Quick Links for Consent Forms 2 Save the appropriate template to
11. escription Test Principal Investigator Rebecca Simms Pl Study Coordinator Carmen Alverado Study Coord Cr edirsudy 4G Study Type Review Type Full IRB Review EL Printer version 5 There are no items to display Ey View SmartForm Progress Funding Sources My Activities 6 2p Notify Team Members to Agree to Participate PI submit Study For Profit Industry pr Withdraw Study tf 8 Fss Copy Study Attachments Change Log ss Pdt Email List This area shows instructions and questions and important notifications regarding this Study Activity Author Activity Date ss Edit Guest List 4 Created study Rebecca Simms Pl 6 9 2009 11 53 AM EDT ss Upload Team Member CW 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 completed The summary panel displays information about this study The information changes when a study becomes active IRB Study Number 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 under its Current State The list will vary dep
12. gulation and Guidance assurance and compliance programs required by Contact Us federal and state agencies and programs for the User Name conduct of research at USF This site enables m the division to manage all aspects of the Password o O Institutional Review Board process Full AAHRPP Accreditation With this Forgot password Forgot user name prestigious distinction USF joins an elite group After signing into this site you are of top research universities and becomes the bound by the terms and conditions set first AAHRPP accredited university in Florida forth when you received your account which has its Human Research Protection Program accredited by AAHRPP Division of Research Integrity amp Compliance Mail 12901 Broce B Downs Bled MOC35 Tampa FL 33612 4799 Phone 813 974 5638 Fax 813 9745618 Copyright 2008 University of South Florida All rights reserved Direct questions or comment about this Web site to jamaldifivesesrch ust edu Last updated July 1 20 Complete the required fields and provide your USF Net ID and Employee ID Select all relevant roles such as Study Staff Pl Department Approver Click Register 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 Password a Account Changes It is important to keep your account information current To make changes to your account click yo
13. n the browser bar e g Internet Explorer Safari AOL Opera 1 1 Study identification Fie Edit View Favorites Tools Help Save your application by clicking Save or Continue WARNING The Back button does not save changes After you enter or edit data on a 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 J ump To drop down menu The title of the displayed page will be red Items not relevant to this study will appear gray in the J ump To menu WARNING After you enter or edit data on a screen click Save before using J ump To The J ump To menu does not save You Are Here Friday Test Study Save Exit Hide Show Errors Print ump To 9 1b HFAA Waiver or Alteration PHI Source Page 2 9 Data Privacy amp Confidentiality 9 1 Protected Health Information 9 1a HIPAA Compliance 9 1b HIPAA Waiver or Alteration PHI Source Disclosure 9 1b HIPAA Waiver or Alteration PHI Source Page 2 9 1b HIPAA Waiver or Alteration PHI Source Page 3 9
14. on can have multiple Roles in elRB PI Co PI Study Coordinator Department Approver IRB Committee member etc Different Roles provide access to different applications information and activities Your current Role will be displayed in the red banner at the top of the column on the left side of your Folder and 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 Click on a role to make it your current role elRB Study Team User Manual 2009 10 12 eiRB Study Team User s Manual Page 6 Navigation Tabs The central area of your Folder My Home provides a row of navigation tabs tivo IRBE Approved Studies Profle Audits ays all tems which Templates Disp require action by the st Inks Tor 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 Whenever you log in or return to your Folder My Home your Inbox is displayed To find out where the application is in the IRB process look in the State column tite IRE Approved Studies Templates Profle Audits Displays all tems which require action by the study team Click on links for more information Filter by Name Po Advanced Name Date Modified Type Owner Last State Change ce h 9 22 2009 9 45 Study Pre Su
15. s Reportable Events s Change Log Activity Author Activity Date IRB Letter Sent to Study Team Richard Arm Comm Chair 8 1 2009 5 05 PM EDT esl RB Drafted Letter To Pl 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 Clean and Strikethrough Copies of Consent Forms section will contain unstamped versions of the approved consent form These documents will be editable in MS Word and should be used if there is a future need to amend the consent forms For major changes you can attach a new revised document e The remainder of this screen displays each question in the SmartForm that allows you to upload a document or file Scroll down to quickly locate any attachment to the application elRB Study Team User Manual 2009 10 12 eiRB Study Team User s Manual Page 16 Creating Reportable 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 Create 1 New Reportable Event P New Amendment Cel New Continuing Review Workspaces for study sub projects are similar to the study Workspace After a reportable event
16. tails When an application is submitted to the IRB and then when it is approved elRB 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 J ump To link that will take you to the page where the requested change needs to be made Error Warning Messages study Message IRB Staff Change Request Author Orlando Max IRB Staff Please send current human subject protections education certificates for two study staf John Arnaldi and Carmen Field Jump To Name 1 2 IRB Researcher Training Records Alverada 3 Respond to each change requested You Are Here New Jail Study Save Exit Hide Show Errors Print Jump To 1 2 IRB Researcher Training Records w Reviewer Notes Filter by Type v Advanced Type Reviewer Modified trsa IRB Staff Change Request hf Response Reguired Click here to respond Please send current human subject protections education certificates for two study staff John Arnaldi and Carmen Alverado 4 Be sure to Save before you Exit the SmartForm elRB Study Team User Manual 2009 10 12 Orlando Max IRB Staff 7 31 2009 10 55 AM eiRB St
17. tted The application must be error free before it can be submitted 3 After the application has been submitted it moves out of 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 Progress Notifications elRB automatically sends e mail notifications to the Study Staff when significant events occur in the review process Be sure to keep your e mail address current in the elRB system To change your e mail address see Account Changes on page 3 The Study Staff 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 elRB Study Team User Manual 2009 10 12 eiRB Study Team User s Manual Page 13 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 de
18. udy Team User s Manual Page 14 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 documents requested My Activities Attachments Pre Review Status Reviewer Notes Change Log Revisions or Information y pepel Department Requests Revisions Or Information Richard Ing Dept App Withdraw Study EF 1 Reviewer Note Logged Edit study title as above ss Edit Email List pr PI Submitted Study Rebecca Simms PI After you have submitted your response the application will not be displayed in your Inbox because it has moved to the IRB 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 elRB 1 In your Folder My Home click the Approved Studies tab 1 Approved Studies J Templates Profile Audits Displays all tems which require action by the study team Click on links for more information Filter by Name Po Advanced Name Date Modified Type Owner State Last State Change e bh Investigational Nasal 4 31 2009 11 33 Study Max IRB Revisions 6 25 2009 10 49 Spray Study AM staff Orlando Requested AM ee Full Board Drug Study Ff29 200
19. ur Inbox 2 Submit the application The PI submits the completed application Submission moves the application out of 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 it attach documents and save changes To prepare a completed application for submission to the IRB 1 In the study Workspace under My Activities click Notify Team Members to Agree to Participate 1 Click OK to send notice to team members My Activities pr Submit Study PI Withdraw Study ss Copy study elRB Study Team User Manual 2009 10 12 eiRB Study Team User s Manual Page 12 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 an application 1 To submit the study to the IRB the PI will open the application Workspace and click Submit Study under My Activities My Activities Notify Team Members to Agree to Participate pr Submit Study PT Withdraw Study ss Copy study 2 elRB 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 submi
20. ur name in the upper right hand corner of your screen to open your account properties Rebecca Simms Pl 9My Home Logoff Then make the necessary changes and click Apply elRB Study Team User Manual 2009 10 12 eiRB Study Team User s Manual Page 4 Passwords To change your password click on your name as described above On your Account page click the Account tab Then in the respective boxes type in your old password your new password and your new password again Click Apply Navigation Log In 1 Type your User Name in the login section on the right side of the elRB screen 2 Type in your Password 3 Click Log In USF NERY OF Logi as sf ogin SOUTH FLORIDA EG ee Home Institutional Review Board Register Here What s New General Information Welcome The Division of Research Integrity amp Compliance administers key research related assurance and compliance programs required Hh federal and state agencies and programs for th conduct of research at USF This site enables the division to manage all aspects of the Institutional Review Board process 3 User Name 2 Password Regulation and Guidance Contact Us Full AAHRPP Accreditation With this Forgot password Forgot user name prestigious distinction USF joins an elite group After signing into this site you are of top research universities and becomes the bound by the terms and conditions set first AAHRPP accr
21. your computer and revise as needed Attach the new or revised copy of the consent form to your application within the study SmartForm You can also create a new study by copying a study to use as a template Open the Study Workspace for the original study and under My Activities click Copy Study After you complete the Copy Study screen the copy will appear under your Templates tab in your Home folder 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 elRB 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 attach relevant documents where indicated elRB Study Team User Manual 2009 10 12 eiRB Study Team User s Manual Page 10 Navigation controls are located in the navigation bar at the top and bottom of each page Use the Continue and Back buttons to move to the next or last viewed screen UNIVERSITY OF SOUTH FLORIDA You Are Here Gare continue gt gt Save Exit Hide Show Errors Print Jump To Fad Use the SmartForm navigation controls instead of the controls i
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