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IRBNet User Manual - Ball State University

1. BA LL STATE UNIVERSITY Office of Research Integrity IRBNet User Manual 6 18 2015 BALL STATE UNIVERSITY Office of Research Integrity User Manual The Office of Research Integrity is pleased to provide Ball State researchers with this manual to assist them in using our online protocol submission system IRBNet Within this document you will find step by step instructions and assistance with first time registration submission continuing review modifications adverse event reporting and study closure If you encounter any problems or have questions regarding the protocol submission process please contact the Office of Research Integrity Contact Office of Research Integrity Teachers College Room 409 765 285 5052 Chris Mangelli John Mulcahy Jennifer Weaver Sandra Currie Director Associate Director Administrator Administrative 765 285 5070 765 285 5106 765 285 5034 Coordinator cmmangelli bsu edu jmulcahy bsu edu jmweaver bsu edu 765 285 5052 slcurrie bsu edu Contents LEE E EO certo see separ sms sot ee ome E oman om ss overeat uo E E E A E ouniaceserseoesiuaticonts 3 RS OU IN isaac etree na arse eat O reset eee ated areas es N O strane teen temeen sree 5 Maor Gas UE he E EENS tece anes E E S 14 NIG CICA Ma Submission Deferred Tetter sisorroiicrieriististi tiressi AE sioki ENERE ANEETA 16 Modityine an Approved Study asisesiissaiisinsiinisiieeiiisvosiueiaiieenianiianieiineiinndaaiia iniiao aaien u
2. BALL STATE UNIVERSITY Office of Research Integrity 3 The screen below will appear click on Designer under the Project Administration tab on the left side of the page Project Overview ee Institution State University Muncie IN Title IRBNet Usability Study Principal Investigator Cardinal Charlie Status Work in progress The documents for this project can be accessed from the Designer Click here to submit this package for review The previous package 383474 1 has a status of Modifications Required Shared with the following IRBNet users Charlie Cardinal Ball State University Muncie IN Full Forms and Templates 4 Click Add New Document to submit a revised document with requested changes Note changes should be made according to the deferral letter sent to the IRBNet e mail address you provided Vhen should do this OR Documents from Previous Packages that you can Revise hen should do this v Application Form Application and Narrative Form 10 01 2012 10 01 2012 Modifications a D 01 44 PM Required 1 Confidentiality Non Confidentiality and non disclosure 10 01 2012 10 01 2012 Modifications E D Disclosure statement 01 46 PM Required 1 Consent Form Informed Consent Letter 10 01 2012 10 01 2012 Modifications E amp 01 45 PM Required Copyright 2002 2012 Research Dataware All Rights Reserved LO q N NS CO Tv VD gs D one gt cD a
3. N Ns CO Ns gs 9 on gt 9 aa F 5 a H 9 N 9 a ea BALL STATE UNIVERSITY Office of Research Integrity 20 Within the Sign Package page you will need to select your role in the project If you are the principal investigator select this option from the drop down box Charlie Cardinal as Principal Investigator x certify that to the best of my knowledge the information contained in this package is accuri pore in accordance with all applicable institutional requirements and is ready for submissia Administrative Reviewer ronic signature is intended to be the legally binding equivalent of a traditional handwritten Advisor Associate Investigator Auditor Author To sign on behalf of ar Co Investigator ee Signature Mode Department Head H Department Representative Institutional Official Monitor Other Signato Principal Investigator Research Coordinator Scientific Reviewer Sponsor Statistician Sub Investigator Team Member cage has not been signed 21 Once you click Sign you will receive a notification from IRBNet that you have signed the package Anyone else that you selected to share the project with will receive an email notifying them of your signature too Similarly when your advisor signs the package you will receive an email notification 22 Once everyone has signed the package you need to submit the pac
4. changes require a new document to be uploaded in its place IRBNet nese wtp wig gt A ae oes Designer 383474 2 IRBNet Usability Study My Projects Step 1 Create New Project Download blank forms document templates and reference materials to assist you in assembling your document package Select a Library Ball State University IRB Muncie IN x Project Oveniew Selecta Document Child Assent Sample _ x Download Designer Share this Project Step 2 Assemble your document package In addition to adding project documents to your package IRBNet also allows you to Sign this Package link your project team s Training amp Credentials to your package Submit this Package Delete this Package New and Revised Documents in this Package se a de Document Type Description LastModified Reviews Application Form Revised Application and Narrative Form 10 01 2012 02 36 PM D h ox Project History There are no Training amp Credentials records linked to this package Link Un Link Training Records Forms and Temple a as is all IRBNet allows you to revise your existing project documents and maintain version history or add entirely new documents to your package Learn more LO q N NS CO Tv VD gs D one gt cD as E 5 S H cD N D Z aa BALL STATE UNIVERSITY Office of Research Integ
5. 4 avie Approved 10 03 2012 10 03 2012 10 03 2012 3 Amendment Modification Approved 10 01 2012 10 01 2012 10 01 2012 2 Revision Approved 10 01 2012 10 01 2012 10 01 2012 Submit this Package 1 New Project Modifications Required 10 01 2012 10 01 2012 10 01 2012 Delete this Package b You are currently viewing this package 7 Fill out and complete the IRB Adverse Event form a This can be obtained in the Forms and Templates section of IRBNet 8 Click Add New Document near the middle of the screen ey a ee Designer 383474 5 IRBNet Usability Study Step 1 Download blank forms document templates and reference materials to assist you in assembling your document package Select a Library Ball State University IRB Muncie IN z Select a Document L Unanticipated Problems and Adverse Events in Research x Download Share this Proje ign this Package Submit this Package Delete this Package New and Revised Documents in this Package 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 There are currently no documents 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
6. Ball State University Muncie IN Select Organization Select an Organization required fields 17 Once the organization is selected you will need to search for the specific user using the page below Please pay attention to the different sharing levels You may want an advisor or a colleague to have a particular level of access Specify the access that you wish to grant to each user at Ball State University 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 e Full Users that a
7. IRBNet Usability Study Research Institution Ball State University Muncie IN Tithe IRBNet Usability Study Principal Investigator Cardinal Charlie The documents for thes project can be accessed from the Designer Project Status as of 08 26 2013 4 Once the changes are made click on Mark Revisions Complete to the right of Unlocked Revisions Pending and View History to resubmit the revised study Designer 383474 6 IRBNet Usability Study This package is gf Unlocked Revisions Pending vew er tenor cog When shouid do thes Get stamped documents approval letters and other board documents and track rewews for this package Review details Step 1 Download blank forms document templates and reference matenals to assist you in assembling your document package Select a Library Baill State University IRB Muncie IN bd Select a Document Child Assent Sample bg Download 5 After you have locked your submission reply to the e mail you recetved from a member of the Office of Research Integrity to let them know you have made the requested changes 10 OD N Ng CO VD a zs D A gt U aa F 5 S 4 D N 4 D Z aa bh BALL STATE UNIVERSITY Office of Research Integrity Modification Submission deferred letter Modifications may be necessary after the Institutional Review Board has reviewed your initial protocol submission This sectio
8. gt U 5 g S H D N 45 D Z ae aa BALL STATE UNIVERSITY Office of Research Integrity Continuing Review Submission expedited and full board Projects may be approved for one or two years You will be notified before your project expires To continue working on a project you must submit and be approved for a continuing review before the expiration date 1 Login to www irbnet org with your username and password 2 Select My Projects on the left side of the screen m la ee i p oy 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 Search By Tag ld 4 1 20f2 gt DI 10 3 Select the project for which you want to submit a continuing review 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 IRBNet Usability Study Cardinal Amendment Approved Modification 381206 1 Cardinal Revision Withdrawn 09 26 2012 a i4 4 1 20f2 gt pi nof LO q N NS CO Tv NS KO g D
9. oe gt cD aa T 5 S H cD N D 2 aa BALL STATE UNIVERSITY Office of Research Integrity 4 Select Project History under the Project Administration menu 383474 3 IRBNet Usability Study Research Institution Ball State University Muncie IN Title IRBNet Usability Study Principal Investigator Cardinal Charlie Status Approved Lock Status Locked The documents for this project can be accessed from the Designer Submitted to Ball State University IRB 10 01 2012 Approved 10 01 2012 Review details The previous package 383474 2 has a status of Approved 383474 3 IRBNet Usability Study The following document packages are available in Project History Amendment Modification 10 01 2012 10 01 2012 10 01 2012 3 Revision pase 10 01 2012 10 01 2012 10 01 2012 1 New Project Modifications Required 10 01 2012 10 01 2012 10 01 2012 Submit this Pac age b You are currently viewing this package Delete this Package Your current document package has already been submitted and is presently locked by your Board You may prepare new Send Pro ect Mail or modified documents such as Revision Amendment materials Renewal Continuing Review materials and Adverse Event Reviews Reports by creating a new document package Project oueruew cote History IRBNet User Manual Revised 06 18 2015 BALL STATE UNIVERSITY Office of Research Integrity 6 New Doc
10. IRBNet Usability Study Principal Investigator Cardinal Charlie Status Approved Lock Status Locked The documents for this project can be accessed from the Designer Submitted to Ball State University IRB 10 03 2012 Approved 10 03 2012 Review details The previous package 383474 3 has a status of Approved Project History 383474 4 IRBNet Usability Study The following document packages are available in Project History Continuing Review Progress Report 10 03 2012 10 03 2012 10 03 2012 3 Amendment Modification msc 10 01 2012 10 01 2012 10 01 2012 2 Revision Approved 10 01 2012 10 01 2012 10 01 2012 1 New Project Modifications Required 10 01 2012 10 01 2012 10 01 2012 b You are currently viewing this package 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 document package E gt LO q N Ns CO Tv Ns KO g D oe gt cD aa a 5 a S H cD NM D 2 aa BALL STATE UNIVERSITY Office of Research Integrity 6 New Document Package will appear click this to be taken to the Designer page ea Project History 383474 5 IRBNet Usability Study The following document packages are available in Project History 10 05 2012
11. l i e certify that to the best of my knowledge the information contained in this package is accurate and complete has been prepared in accordance with all applicable institutional requirements and is ready for submission further certify that this electronic signature is intended to be the legally binding equivalent of a traditional handwritten signature Project Overview Designer Share this Project To sign on behalf of another person switch to Designee Signature Mode lt 4 See a This package has been signed by Delete tis Patrage SignedBy RO 10 01 2012 02 53 PM Charlie Cardinal Principal Investigator Details Send Project Mail LO D N Ng CO NS O D gs D on gt U g S H D N 4 D Z ae aa BALL STATE UNIVERSITY Office of Research Integrity 11 Search for and select the proper review body at Ball State University IRB L ACUC IBC and click Continue Search for an Organization Ball State University Ball State University IRB Muncie IN Ball State University ASPIRE Grant Program Muncie IN Ball State University IACUC Muncie IN Select a Board Ball State University IBC Muncie IN required fields 12 Select Revision for Submission Type arrow and then click Submit Submit Package 383474 7 IRBNet Usability Study The following IRBNet users at Ball State University IRB will be automatically no
12. new documents to your package Learn more LO q N NS CO Tv KO gs D one gt cD aa a 5 a S H cD NM D 2 aa p BALL STATE UNIVERSITY Office of Research Integrity 9 Inthe Document Type box select the category the bests matches the document you are uploading If this is an adverse event or serious adverse event select Adverse Event Report If this is an Unanticipated Problem select Unanticipated Problem Report Click Choose File arrow to browse your computer for the desired file Once found click Attach to upload the file to your package Attach Document 383474 5 IRBNet Usability Study My Projects You may attach documents to this package by clicking the Browse button to locate a document and then by clicking Create New Project Attach The Document Type and optional Description are informational fields to assist you in managing your attached 43 documents Document Type Adverse Event Report Description Adverse Event Report File Choose File L Project Overview Designer Share this Project Sign this Package Submit this Package Delete this Package Send Project Mail required fields Reviews 10 Click Sign this Package under the Project Administration menu on the left side of the screen Designer 383474 5 IRBNet Usability Study My Projects Step 1 Create New Proiect Download blank forms
13. role arrow and click Sign Sign Package Charlie Cardinal as o the best of my knowledge the information contained in this package is accur pared in accordance with all applicable institutional requirements and is ready for submissia Administrative Reviewer onic signature is intended to be the legally binding equivalent of a traditional handwritten Advisor Associate Investigator Auditor Author To sign on behalf of ar Co Investigator se Signature Mode i Department Head Department Representative Institutional Official Project Overview Designer Share this Project ign this Pac Submit this Package Delete this Package Send Project Mail Reviews Project Histo age has not been signed Research Coordinator Scientific Reviewer Sponsor Statistician Sub Investigator Team Member 13 Your modification amendment is now ready to submit click Submit this Package under the Project Administration menu RBN m wi lee Oo Sign Pa Package My Projects Create New Proje Project Overview Je igi er Share this toect 383474 3 IRBNet Usability Study Charlie Cardinal as Principal Investigator certify that to the best of my knowledge the information contained in this package is accurate and complete has been oasi in accordance with all applicable institutional requirements and is ready for submission further certify that this electronic signature is intended to be t
14. 2012 10 01 2012 Download blank forms document templates and reference materials to assist you in assembling your document package Assemble your document package In addition to adding project documents to your package IRBNet also allows you to IRBNet allows you to revise your existing project documents and maintain version history or add entirely new documents to Office of Research Integrity ma History 10 08 2012 10 03 2012 10 01 2012 10 01 2012 10 01 2012 LO q N NS CO Tv KO gs D one gt cD aa a 5 a S H cD NM D 2 aa p BALL STATE UNIVERSITY Office of Research Integrity 9 Inthe Document Type box select the category the bests matches the document you are uploading If you are uploading the IRB Final Report select Closure Final Report Click Choose File arrow to browse your computer for the desired file Once found click Attach to upload the file to your package CI AR A7 Attach Document 383474 6 IRBNet Usability Study 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 Create New Project Document Type Closure Final Report Description Final Report Form File Choose FK h Project Overview D
15. Auditor ie Author Te To sign on behalf of ar Co Investigator ee Signature Mode Department Head Department Representative Institutional Official age has not been signed rincipal investigator Research Coordinator Scientific Reviewer Sponsor Statistician Sub Investigator Team Member 12 Your Adverse Event form is now ready to submit click Submit this Package under the Project Administration menu Sign Package 383474 5 IRBNet Usability Study Charlie Cardinal as Principal Investigator x certify that to the best of my knowledge the information contained in this package is accurate and complete has been prepared in accordance with all applicable institutional requirements and is ready for submission further certify that this electronic signature is intended to be the legally binding equivalent of a traditional handwritten signature To sign on behalf of another person switch to Designee Signature Mode This package has been signed by 10 05 2012 04 33 PM Charlie Cardinal Principal Investigator LO q N NS CO Tv KO gs D one gt cD aa a 5 a S H cD NM D 2 aa p BALL STATE UNIVERSITY Office of Research Integrity 13 Search for and select the proper review body at Ball State University IRB LACUC IBC and click Continue Search for an Organization Ball State University Ball State University IRB Muncie IN
16. COI and other Boards with a unified so fast the members didn t know solution what to do They just sat there for a few minutes in disbelief Flexible Intuitive and Easy to Use Bruce Day Your own forms Your own processes Your own standards Powerful reporting and performance Bruce Day metrics The data you need From electronic submissions to form wizards to agendas minutes and Director Office of Research Integrity 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 solution is accessible to your research community anytime anywhere Our enterprise class technology is cost effective and designed to accommodate institutions of any size 9012 Events Join Us OHRP Regional Forum i New Orleans LA January 13 i h PRIM amp R Annual IACUC Conference Boston MA March 20 21 bial Try the demo and see for yourself Qh N NS 0 SS O gt o U me gt U 5 g H D N 4 D Z ae aa BALL STATE UNIVERSITY Office of Research Integrity 2 On the left side of the page select Create New Project 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 a
17. University IRB LACUC IBC and click Continue Search for an Organization Ball State University Ball State University IRB Muncie IN Ball State University ASPIRE Grant Program Muncie IN Ball State University IACUC Muncie IN Scluct a Boardi Ball State University IBC Muncie IN required fields 14 Select Closure Final Report for Submission Type arrow and then click Submit submit Package 383474 6 IRBNet Usability Study The following IRBNet users at Ball State University IRB will be automatically notified of your submission Byers Bryan Mangelli Chris Mulcahy John Weaver Jennifer Submission Type Closure Final Report Adverse Event non UP You may also specify additional comments tq Amendment Modification CosureFnalRepot O Continuing Review Progress Report Funding Grant Your Comments New Project Other Other Reportable Event LO q D N Ng CO vl NS VD D go D on gt U 5 g S H D N 45 D Z ae aa
18. a a 5 a S H cD NM D 2 aa _ BALL STATE UNIVERSITY Office of Research Integrity 5 Your project will be locked and you will be unable to edit documents that have already been submitted Click Create New Package to submit a revised version of the documents requested Package is Locked 383474 6 IRBNet Usability Study Your current document package has already been submitted and is presently locked by your Board My Projects Create New Project Project Overview Designer Share this Project Sign this Package Submit this Package Delete this Package Send Project Mail You may contact your Board and request that they unlock the package This will allow you to make modifications directly to this package instead of creating a new package 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 package for this study Creating a new document package will allow you make changes while also automatically retaining the current versions of all documents as part of your electronic audit trail 6 Create complete and submit the appropriate documents Reviewers will be interested in seeing changes that you have made from your original document For minor changes e g grammatical changes simply highlighting the change in the new document ts sufficient However larger
19. a Ball State University ASPIRE Grant Program Muncie IN Ball State University IACUC Muncie IN Solaet a Bird T Ball State University IBC Muncie IN required fields UNANTICIPATED PROBLEM SUBMISSION SEE STEP 14 SERIOUS ADVERSE EVENT AND ADVERSE EVENT SUBMISSIOM SEE STEP 15 14 Select Unanticipated Problem UP for Submission Type arrow and then click Submit ORI must be contacted within 5 days of the unanticipated problem Submit Package 383474 5 IRBNet Usability Study The following IRBNet users at Ball State University IRB will be automatically notified of your submission Byers Bryan Mangelli Chris Mulcahy John Weaver Jennifer Submission Type Unanticipated Problem UP New Project You may also specify additional comments tq Other Other Reportable Event Protocol Deviation Violation Publication Your Comments Response Follow Up Revision Unanticipated Problem UP LO q D N Ng CO vl NS VD D go D on gt U 5 g S H D N 45 D Z BALL STATE UNIVERSITY Office of Research Integrity 15 Select Adverse Event non UP for Submission Type arrow and then click Submit ORI must be contacted within 24 hours of the unanticipated problem Submit Package 383474 5 IRBNet Usability Study e Adverse Event non UP v ze Fyent fnon_lif Amendment Modification Closure Final Report Continuing Review Progress R
20. aa T 5 S H cD N D Z aa p BALL STATE UNIVERSITY Office of Research Integrity 4 Click on Project History under the Project Administration menu y yy m i j X en _ Ss Project Overview wi 383474 2 IRBNet Usability Study Research Institution Ball State University Muncie IN Title IRBNet Usability Study Principal Investigator Cardinal Charlie Designer _ Lock Status Locked ign this Package Submit this Pac Delete this Package Submitted to Send Project Mail Ball State University IRB 10 01 2012 Approved 10 01 2012 Review details The documents for this project can be accessed from the Designer aue The previous package 383474 1 has a status of Modifications Required Shared with the following IRBNet users Charlie Cardinal Ball State University Muncie IN Full Forms and Te 5 Click Create New Package at the bottom of the page Project History 383474 2 IRBNet Usability Study The following document packages are available in Project History Revision Approved 10 01 2012 10 01 2012 10 01 2012 New Project Modifications Required 10 01 2012 10 01 2012 10 01 2012 ea You are currently viewing this package 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 materia
21. aviinosadand 22 Annual Continuing Review Submission Expedited and Full Board sssessessssssesesesesrsrsrsrsesrrrrrrerereees 28 PAG e Tees SUM O E E R eco geese cae ES E E E E NE 34 Final Report Submission Expedited and Full Board ssssssesssssesssesessesesrsesesesessssssssrsesrsrsrsrsesesreseeseeeresrsess 41 LO vl N NS CO vl NS VD ae 9 aae gt 9 ad a fax 5 S an ke Pa 9 N 5 Z aa pA BALL STATE UNIVERSITY Office of Research Integrity Registration 1 Navigate to http www irbnet org Username Password IRBNet Innovative Solutions for Login W pe a Compliance and Research Management sin df New User Registration Forgot Your Password Home The IRBNet Difference Demo Contact Us FAQ 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 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 solution what to do They just sat there for a few minutes in disbelief Flexible Intuitive and Easy to Use Brace Day Your own forms Your own processes Your own standards Powerf
22. been signed by Delete this Package Date Signed By RO Send Project Mail 10 03 2012 04 34 PM Charlie Cardinal Principal Investigator Details IRBNet User Manual Revised 06 18 2015 BALL STATE UNIVERSITY Office of Research Integrity 15 Search for and select the proper review body at Ball State University IRB LACUC IBC and click Continue Search for an Organization Ball State University Ball State University IRB Muncie IN Ball State University ASPIRE Grant Program Muncie IN Ball State University IACUC Muncie IN Scluct a Boardi Ball State University IBC Muncie IN required fields 16 Select Continuing Review Progress Report for Submission Type arrow and then click Submit submit Package 383474 4 IRBNet Usability Study The following IRBNet users at Ball State University IRB will be automatically notified of your submission Byers Bryan Mangelli Chris Mulcahy John Weaver Jennifer Submission Type Continuing Review Progress Report Y Adverse Event non UP You may also specify additional comments tq Amendment Modification Closure Final Report Funding Grant Your Comments New Project Other Other Reportable Event LO q D N Ng CO vl NS VD D go D on gt U 5 g S H D N 45 D Z ae aa BALL STATE UNIVERSITY Office of Research Integrity Adverse Events Submission NOTE Non serious adverse events i e loss
23. cument package Select a Library Ball State University IRB Muncie IN_ z Select a Document Child Assent Sample Download 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 New and Revised Documents in this Package There are currently no documents in this package Forms and Templates 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 package Learn more LO q N NS CO Tv KO gs D one gt cD aa a 5 a S H cD NM D 2 aa p BALL STATE UNIVERSITY Office of Research Integrity 10 In the Document Type box select the category the bests matches the document you are uploading If you are uploading the modification amendment form select Amendment Modification If you are uploading supporting documentation pick the best match If there is no match select other Click Choose File arrow to browse your computer for the desired file Once found click Attach to upload the file to your package Attach Jaunen 383474 3 IRBNet Usability Study You may attach documents to this package by clicking the Browse button
24. document templates and reference materials to assist you in assembling your document package A g 3 Select a Library Ball State University IRB Muncie IN o x Project OMON Select a Document Child Assent Sample x Download Designer r of T aner man Step 2 A Sign this Package Assemble your document package In addition to adding project documents to your package IRBNet also allows you to Su link your project team s Training amp Credentials to your package Delete this Package New and Revised Documents in this Package wT Description _ Last Modified pS Y Adverse Event Report Adverse Event Report 10 05 2012 04 30 PM fy 8 x There are no Training amp Credentials records linked to this package Link Un Link Training Records LO q N Ns CO Tv Ns g D on gt cD as E 5 S H cD N D Z aa BALL STATE UNIVERSITY Office of Research Integrity 11 Once at the Sign Package screen indicate your project role arrow and click Sign Sign Package 383474 5 IRBNet Usability Study Charlie Cardinal as Principal Investigator _ o the best of my knowledge the information contained in this package is accur pared in accordance with all applicable institutional requirements and is ready for submissia Administrative Reviewer onic signature is intended to be the legally binding equivalent of a traditional handwritten Advisor Associate Investigator
25. e v 3 Download 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 Link Un Link Training Records All forms are located in the Library manager on IRBNet a IRBNet My Projects Create New Project PE 7 Make sure you have completed all pieces of the Human Subjects Research Application and Protocol Form and created separate documents for possible recruitment materials surveys and informed consent forms LO D N Ng CO NS O D gs D on gt U 5 g H D N 4 D Z ae pA BALL STATE UNIVERSITY Office of Research Integrity 8 Within the Designer page click Add New Document Step 1 Download blank forms document templates and reference materials to assist you in assembling your document package Select a Library Ball State University IRB Muncie IN o Select a Document IRB Human Subjects Research Application and Narrative v 3 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
26. ent Type Continuing Review Progress Report Description Annual Continuing Review Form File choose Fie K J vird Tah required fields 11 Repeat steps 9 and 10 for all additional supporting documents until they have been added to your package if necessary 12 Click Sign this Package under the Project Administration menu on the left side of the My Projects Create New Project Designer 383474 4 IRBNet Usability Study Step 1 Download blank forms document templates and reference materials to assist you in assembling your document package Select a Library Ball State University IRB Muncie IN x Select a Document Child Assent Sample owntoad 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 New and Revised Documents in this Package DocumentType LastModified Y Continuing Review Progress Report Annual Continuing Review Form 10 03 2012 12 57 PM F 8 x There are no Training amp Credentials records linked to this package Link Un Link Training Records LO q N NS CO Tv VD gs D one gt cD as E 5 S H cD N D Z aa BALL STATE UNIVERSITY Office of Research Integrity 13 Once at the Sign Package screen indicate your project role arrow and click Sign py
27. eport Funding Grant New Project Other Other Reportable Event LO bn N Ssg CO _ NS KO a gs D oo gt U aa F m a H D N D a pA BALL STATE UNIVERSITY Office of Research Integrity Final Report Submission Expedited and Full Board When your project is complete you will submit a final report submission to close your project on IRBNet 1 Login to www irbnet org with your username and password 2 Select My Projects on the left side of the screen 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 _ unning smoothly Learn More Search I4 4 1 20f2 gt bi 10i 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 I4 4 1 20f2 gt bi 10a LO q N NS CO Tv NS KO gs D one gt cD aa T 5 S H cD N D 2 aa BALL STATE UNIVERSITY Office of Research Integrity 4 Select Project History under the Project Administration menu
28. esigner Share this Project Sign this Package Submit this Package Delete this Package Send Project Mail Reviews Project History required fields 10 Click Sign this Package under the Project Administration menu on the left side of the screen Designer 383474 6 IRBNet Usability Study Step 1 Download blank forms document templates and reference materials to assist you in assembling your document package Select a Library Ball State University IRB Muncie IN zl Select a Document Child Assent Sample Download 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 New and Revised Documents in this ere Document Type riptior ast Modifie E Closure Final Report Final Report F Form 10 08 2012 10 27 AM a 3 x Project Histo IRBNet User Manual Revised 06 18 2015 BALL STATE UNIVERSITY Office of Research Integrity 11 Once at the Sign Package screen indicate your project role arrow and click Sign Sign Package 383474 6 IRBNet Usability Study Charlie Cardinal as Principal Investigator certify that to the best of my knowledge the information contained in this package is accur pared in accordance with all applicable institutional requirements and is ready for submissio Administrative Reviewer onic signatu
29. fy 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 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 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 LO D N Ng CO NS O as D on gt U 5 g S H D N 4 D Z ae aa BALL STATE UNIVERSITY Office of Research Integrity 16 The following screen will appear and you can search for the organization with which the person you would like to share the project with is affiliated You may share this project with other IRBNet users Sharing a project consists of three steps 1 Select an organization to display a list of IRBNet users at that organization 2 Specify the access that you wish to grant each user at that organization 3 Save your changes Search for an Organization Organization pe Research Institutions Boards _ Sponsors Auke Bay Laboratories Juneau AK Aurora Health Care Milwaukee WI Automotive Flint MI AventuSoft LLC Tamarac FL AZ DHS Public Health Statistics Phoenix AZ Azusa Pacific University Azusa CA Baker College Center for Graduate Studies Flint MI
30. he legally binding equivalent of a traditional handwritten signature To sign on behalf of another person switch to Designee Signature Mode mee lt This package has been signed by Submit this Pack gt a Pi Send Proje Mail 10 01 2012 04 29 PM_ Charlie Cardinal Principal Investigator Reviews Project Histo IRBNet User Manual Revised 06 18 2015 BALL STATE UNIVERSITY Office of Research Integrity 14 Search for and select the proper review body at Ball State University IRB LACUC IBC and click Continue Search for an Organization Ball State University Ball State University IRB Muncie IN Ball State University ASPIRE Grant Program Muncie IN Ball State University IACUC Muncie IN Salect a Board Ball State University IBC Muncie IN required fields 15 Select Amendment Modification for Submission Type arrow and then click Submit submit Package 383474 3 IRBNet Usability Study The following IRBNet users at Ball State University IRB will be automatically notified of your submission Byers Bryan Mangelli Chris Mulcahy John Weaver Jennifer Submission Type Amendment Modification Adverse Event non UP You may also specify additional comments t Closure Final Report Continuing Review Progress Report Funding Grant Your Comments New Project Other Other Reportable Event LO q D N Ng CO vl NS VD D go D on
31. i it Messages amp Alerts 3 Confidentiality Non Disclosure Revised Confidentiality and non disclosure 1012012 02 45 Pl i fh P x B l statement ier Too Consent Form Revised Informed Consent Letter 10 01 2012 02 46 PM Fi hy 3 x Forms and Templates Other Summary of changes 10 01 2012 02 45 Ph Ei 2 a IRBNet User Manual Revised 06 18 2015 BALL STATE UNIVERSITY Office of Research Integrity 9 Once at the Sign Package screen indicate your project role arrow and click Sign sign Package 383474 2 IRBNet Usability Study Charlie Cardinal as Principal Investigator t to the best of my knowledge the information contained in this package is accur pared in accordance with all applicable institutional requirements and is ready for submissio Administrative Reviewer onic signature is intended to be the legally binding equivalent of a traditional handwritten Advisor Associate Investigator Auditor Author To sign on behalf of aj Co Investigator ee Signature Mode Department Head Department Representative Institutional Official Monitor Other Signatary Principal Investigator Research Coordinator Scientific Reviewer sponsor Statistician sub Investigator Team Member 10 Your project is now ready to submit click Submit this Package under the Project Administration menu sign Package 383474 2 IRBNet Usability Study Charlie Cardinal as i f
32. ically recorded Please select a Board Search for an Organization Arkansas State University IBC Jonesboro AR Arnold Palmer Medical Center APMC IRB Orlando FL Aspire IRB San Diego CA Aspirus Wausau Hospital Wausau WI Atlantic Health System Morristown NJ Aultman Health Foundation Canton OH Azusa Pacific University Azusa CA Ball State University IRB Muncie IN v Select a Board required fields 27 You need to select the submission type select New Project from the dropdown box If you would like to include any comments that will be sent to the reviewers feel free to do SO Click Submit The following IRBNet users at Ball State University IRB will be automatically notified of your submission Byers Bryan Mangelli Chris Mulcahy John Weaver Jennifer Submission Type You may also specify additional comments to be included in this notification Your Comments 28 The reviewers will now be notified of your submission and the review process can begin You will receive a time stamp for the submission IRBNet User Manual Kevised U0 18 ZU15 BALL STATE UNIVERSITY Office of Research Integrity Minor Revisions Unlock Minor modifications may be necessary after the applicable committee has reviewed your initial protocol submission This section of the user manual will guide principal investigators in the steps necessary to submit minor modifications You wi
33. ision Amendment materials Renewal Continuing Review materials and Adverse Event Reports by creating a new document package E gt IRBNet User Manual Revised 06 18 2015 BALL STATE UNIVERSITY 6 New Document Package will appear click this to be taken to the Designer page 383474 6 IRBNet Usability Study The following document packages are available in Project History b You are currently viewing this package 7 Fill out and complete the IRB Final Report form b This can be obtained in the Forms and Templates section of IRBNet 8 Click Add New Document near the middle of the screen IK P Work in progress 4 minusa E E Report Approved 3 Amendment Modification Approved 2 Revision Approved 1 New Project Modifications Required 10 08 2012 10 05 2012 10 03 2012 10 01 2012 10 01 2012 10 01 2012 y yr z ST M E7 383474 6 IRBNet Usability Study Step 1 Select a Library Ball State University IRB Muncie IN x IRB Final Report Study Closure Form Select a Document Step 2 link your project team s Training amp Credentials to your package New and Revised Documents in this Package There are currently no documents in this package There are no Training amp Credentials records linked to this package your package Learn more Link Un Link Training Records Download Designer 10 05 2012 10 03 2012 10 01 2012 10 01
34. kage A package cannot be submitted until everyone has signed the package If you have an advisor the advisor must sign the package before you submit the package to the IRB for review 23 Unless all signatures are handled at once you will likely need to access IRBNet at another time once you receive notification that everyone has signed the package Sign back into your IRBNet account 24 You can select your project from the list after signing in 25 Look again to the Project Administration section and select Submit this package 238 C coe ef Ig A a a Project Overview Send Project Mail LO q D N Ng CO vl NS VD D go D on gt U 5 g S H D N 45 D Z ae aa BALL STATE UNIVERSITY Office of Research Integrity 26 The page below will appear You want to be sure to select Ball State University IRB Muncie IN Once this is highlighted click Continue IRBNet supports multiple models of review Using the IRBNet Submit feature you may electronically submit this document package to either a single Board or to multiple Boards Each Board you submit to will be notified of your submission and given access to view your electronic documents Each Board will also be permitted to electronically record their review decision which will be stored as a permanent part of your project record You will be automatically notified when the review decision is electron
35. ll receive an e mail indicating that your project has been unlocked and modifications are required 1 Login to www irbnet oreg with your username and password and then click on the My Projects button on the left side navigation menu UA OEO ya i y Spee 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 Search By Tag v Search Clear My Projects 2 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 I4 d 1 20f2 p bl 10 Create and Manage Tags Show Archived Projects 1 3934742 IRBNet Usability Study Cardinal Work in progress Y 3812061 New Project Cardinal Withdrawn 09 26 2012 Fi Id 4 1 20f2 p bi 10 e IRBNet User Manual Kevised U0 18 ZU BALL STATE UNIVERSITY Office of Research Integrity 3 Click on Unlocked Revisions Pending in red to the right of the Package number On the next screen you will complete the requested changes Project Overview 383474 6
36. ls and Adverse Event Reports by creating a new document package LO q N NS CO Tv NS KO gs D one gt cD aa a 5 a S H cD NM D 2 aa p BALL STATE UNIVERSITY Office of Research Integrity 6 New Document Package will appear click this to be taken to the Designer page Project History 383474 3 IRBNet Usability Study The following document packages are available in Project History ork in progress 10 01 2012 visi Approved 10 01 2012 10 01 2012 10 01 2012 1 New Project Modifications Required 10 01 2012 10 01 2012 10 01 2012 b You are currently viewing this package 7 Fill out and complete the IRB Modification Amendment Form a This can be obtained in the Forms and Templates section of IRBNet 8 Prepare any additional relevant project documents indicated in the IRB Modification Amendment Form This could include Informed consent documents parental submission documents surveys recruitment letters or e mails introductory scripts and any additional documentation that will assist the committee in understanding the changes you are making to the study All changes must be highlighted otherwise your study won t be reviewed 9 Click Add New Document near the middle of the screen Designer 383474 3 IRBNet Usability Study Step 1 Download blank forms document templates and reference materials to assist you in assembling your do
37. n of the user manual will guide principal investigators in the steps necessary to submit modifications You will receive an e mail from the IRB Chair indicating that Modifications are Required 1 Login to www irbnet ore with your user name and password and then click on the My Projects button on the left side navigation menu 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 Search By Tag v aA a eS g C N y uari r u F a a 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 and keep it running smoothly Learn More Create New Project Farms and Templates sears d CCSo arch By Tags I4 d 1 20f2 gt bl 10 Create and Manage Tags Show Archived Projects 1 my A JEL B a ee C 384742 IRBNet Usability Study Cardinal Work in progress Y 331206 1 New Project Cardinal Withdrawn I4 4 1 20f2 gt bi 10 fe LO q N NS CO Tv NS KO gs D one gt cD aa a 5 a S H cD NM D 2 aa i
38. nd Archiving to help organize your workspace and keep it running smoothly Learn More Search Forms and Templates 3 The following screen will appear Create a 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 Ball State University Muncie IN First Name ______ Last Name _ Degreota You may specify an internal account number billing identifier or reference number for this project Internal Reference Number required fields LO q N NS CO Tv VD gs D one gt cD aa a 5 a S H cD NM D 2 aa p BALL STATE UNIVERSITY Office of Research Integrity 4 Enter the title of the project and your name If the study is sponsored please enter the funding agency s name in the sponsor box The keywords box may be useful for you if you have several studies and need to find this study at a later time based upon a specific keyword 5 Click continue 6 You will be taken to the Designer page and the following screen will appear Step 1 Download blank forms document templates and reference materials to assist you in assembling your document package Select a Library Ball State University IRB Muncie IN x Select a Document IRB Human Subjects Research Application and Narrativ
39. of non identifiable data must be submitted to the Office of Research Integrity within 5 business days Serious adverse events i e loss of identifiable data injury and or death must be reported within 24 hours 1 Login to www irbnet ore with your username and password 2 Select My Projects on the left side of the screen l ceed a aen y j M x 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 lt My Projects _ _ unning smoothly Learn More Search Search By Tag Create f ject I4 4 1 20f2 gt bi ioie TK 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 Y 381206 1 New Project I4 4 1 20f2 gt pi 10 LO q N NS CO Tv NS KO gs D one gt cD aa F 5 a S H cD N D 2 aa BALL STATE UNIVERSITY Office of Research Integrity 4 Select Project History under the Project Administration menu nnn Overview Research Institution Ball State University Muncie IN Title
40. pr Y m yr p Project Overview 383474 5 IRBNet Usability Study Research Institution Ball State University Muncie IN Title IRBNet Usability Study Principal Investigator Cardinal Charlie Status Withdrawn Designer _ Lock Status Locked Share this Proje Project Overview ign this Package Submit this Package Delete this Package Send Project Mail The documents for this project can be accessed from the Designer Submitted to Ball State University IRB 10 05 2012 Withdrawn 10 08 2012 Review details The previous package 383474 4 has a status of Approved Project History p panao PP 5 Click Create New Package at the bottom of the page Project History 383474 5 IRBNet Usability Study The following document packages are available in Project History Adverse Event non UP 10 05 2012 10 05 2012 10 08 2012 i Continuing Review Progress Report RA 10 03 2012 10 03 2012 10 03 2012 3 Amendment Modification Approved 10 01 2012 10 01 2012 10 01 2012 2 Revision Approved 10 01 2012 10 01 2012 10 01 2012 Submit this Package 1 New Project Modifications Required 10 01 2012 10 01 2012 10 01 2012 Delete this Package Send Project Mail Reviews Project History b You are currently viewing this package Your current document package has already been submitted and is presently locked by your Board You may prepare new or modified documents such as Rev
41. re granted Full access can perform all functions without restriction This includes editing project documents sharing the project with other users submitting document packages for review and deleting document packages Only Project Owners with day to day responsibility for the project should be granted Full access Users with Full access will receive automatic email copies of all project notifications and alerts that are sent to the Project Owners Search for a User LO D N Ng CO NS O ae D on gt U 5 g S H D N 4 D Z ae aa BALL STATE UNIVERSITY Office of Research Integrity 18 Once the user is found you may grant the appropriate level of access Within the Comments box you can enter any additional comments that will be included in the e mail to the specified IRBNet user which notifies them of their new access to your protocol Search for a User Cardinal Search _ IRBNet User Permission Access Cardinal Charlie Full Write Read No Access Each user will be automatically notified that they have been granted access to this project You may also specify additional comments to be included in this notification Your Comments 19 The next step is to navigate to the Sign this Package section Remember student PPs must have faculty advisor sign the package before you can submit the package for review LO g
42. re is intended to be the legally binding equivalent of a traditional handwritten Advisor Associate Investigator a Auditor mip Author To sign on behalf of ar Co Investigator ee Signature Mode Department Head Department Representative Institutional Official Monitor age has not been signed Other Signato Principal Investigator Research Coordinator Scientific Reviewer Sponsor Statistician Sub Investigator Team Member 12 Your Final Report Study Closure form is now ready to submit click Submit this Package under the Project Administration menu Sign Package 383474 6 IRBNet Usability Study Charlie Cardinal as Principal Investigator certify that to the best of my knowledge the information contained in this package is accurate and complete has been prepared in accordance with all applicable institutional requirements and is ready for submission further certify that this electronic signature is intended to be the legally binding equivalent of a traditional handwritten signature To sign on behalf of another person switch to Designee Signature Mode This package has been signed by 10 08 2012 10 30 AM Charlie Cardinal Principal Investigator Details LO q N NS CO Tv KO gs D one gt cD aa a 5 a S H cD NM D 2 aa p BALL STATE UNIVERSITY Office of Research Integrity 13 Search for and select the proper review body at Ball State
43. rity 7 Inthe document type menu select the most appropriate match for the document you are uploading If there is no match select Other from the menu Select the Choose File tab to browse your computer for desired file arrow Click the Attach button to upload the file to yout package Attach Document 3534 74 27 IRBNet Usability Study 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 required fields 8 Click the Sign this Package under the Project Administration menu on the left j Designer 383474 7 IRBNet Usability Study Step 1 Create New Project Download blank forms document templates and reference materials to assist you in assembling your document package Select a Library Ball State University IRB Muncie IN Select a Document Child Assent Sample Download Project z Step 2 Assemble your document package In addition to adding project documents to your package IRBNet also allows you to Mal link your project team s Training amp Credentials to your package Delete t Documents in this Package Document Type scription Last Modified Application Form Revised Application and Narrative Form 10 01 2012 02 36 PM Fi h OX Project History z
44. roject 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 no documents 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 package Learn more LO q N NS CO Tv KO gs D one gt cD aa a 5 a S H cD NM D 2 aa p BALL STATE UNIVERSITY Office of Research Integrity 10 In the Document Type box select the category the bests matches the document you are uploading If you are uploading the IRB Continuing Review Form select Continuing Review Progress Report If you are uploading supporting documentation pick the best match if there is no match select Other Click Choose File arrow to browse your computer for the desired file Once found click Attach to upload the file to your package eate New Proje Attach Document 383474 4 IRBNet Usability Study 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 Docum
45. this Package There are currently no documents in this package There are no Training amp Credentials records linked to this package Link Un Link Training Records 9 Once you click Add New Document this screen will appear 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 _ Description Sr File Browse required fields 10 Within this Document Type select Application Form 11 Browse for the file on your computer and click Attach 12 If you have additional materials such as a file containing recruitment materials survey questions consent forms proof of CITI training letter of support etc complete these steps again For document type select the name that best represents what is in the additional document or choose Other and type what the document is in the Description box IRBNet User Manual Revised 06 18 2015 BALL STATE UNIVERSITY Office of Research Integrity 13 Once all files have been uploaded you need to share your study with others Student PI s must share the project with faculty advisor before submitting This could also include other advisors or colleagues To share your project with another person the person must be registered
46. tified of your submission Byers Bryan Mangelli Chris Mulcahy John Weaver Jennifer Submission Type New Project You may also specify additional comments tq ter Other Reportable Event Protocol Deviation v iolation Publication Your Comments Response Follow Up 4 Unanticipated Problem UP LO qa N NS CO vv RO zs D one gt cD aa j 5 S H cD N ma D Z ae BALL STATE UNIVERSITY Office of Research Integrity Modifying an Approved Study 1 Login to www irbnet ore using your username and password 2 Select My Projects on the left side of the screen 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 gt running smoothly Learn More Search Y 283474 2 IRBNet Usability Study Y 381206 1 New Project ld 4 1 20f2 gt bi r0 fe 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 I4 4 1 20f2 b bi 10 fe LO s N NS CO Tv NS KO gs D one gt cD
47. 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 Amendment Modification f l 11 Repeat steps 9 and 10 for all additional supporting documents until they have been added to your package 12 Click Sign this Package under the Project Administration menu on the left side of the screen Designer 383474 3 IRBNet Usability Study Step 1 Download blank forms document templates and reference materials to assist you in assembling your document package Select a Library Ball State University IRB Muncie IN x Select a Document Child Assent Sample iy Download 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 New and Revised Documents in this Package Document Type Description LastModified v Amendment Modification Human Subjects Modification Amendment 10 01 2012 04 23 PM a 3 x Request Form V Consent Form Modified Informed Consent Letter 10 01 2012 04 23 PM P 8 x LO g N Ns CO Ns g 9 on gt 9 aa F 5 H 9 N 9 Z as ad BALL STATE UNIVERSITY Office of Research Integrity 13 Once at the Sign Package screen indicate your project
48. ue and enter your contact information The e mail address entered will be the one used to contact you regarding IRB decisions related your future protocol s 8 Confirm all the information that you have entered and be sure that you are listed as a Researcher at Ball State University 9 After completing your registration you will receive an e mail from IRBNet Use the provided link within this e mail to finalize your registration LO vl N NS CO vl NS VD ae 9 aae gt 9 ad a fax 5 S an ke a 9 N 5 Z aa BALL STATE UNIVERSITY Office of Research Integrity Creating your study 1 Navigate to www irbnet org and login using the username and password you created from the previous section If you have not created an account please follow the necessary steps in the Registration section of this manual IRBNet Innovative Solutions for Compliance and Research Management Home The IRBNet Difference Demo Contact Us FAQ Username Password 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 went so smoothly It was over management and oversight tools support your IRB IACUC IBC
49. ul reporting and performance Bruce Day metrics The data you need From electronic submissions to form wizards to agendas minutes and Director Office of Research Integrity 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 solution is accessible to your research community anytime anywhere Our enterprise class technology is cost effective and designed to accommodate institutions of any size 9012 Events Join Us OHRP Regional Forum w New Orleans LA January 13 PRIM amp R Annual IACUC Conference Boston MA March 20 21 e RTT ere Try the demo and see for yourself 2 Look for the login box located in the upper right portion of the website 3 Click on New User Registration as circled Username Password df New User Registration Login Forgot Your Password 4 Fill in the information necessary to create your account 5 After you click continue accept the Terms of Use LO D N Ng CO NS O ae D on gt U 5 g S H D N 4 D Z ae aa BALL STATE UNIVERSITY Office of Research Integrity 6 Select Ball State University To do this type Ball State University in the search for an organization space 7 Click contin
50. ument Package will appear click this to be taken to the Designer page Project History 383474 4 IRBNet Usability Study The following document packages are available in Project History A ee Work in progress 10 03 2012 So 3 Approved 10 01 2012 10 01 2012 10 01 2012 Share this Project 2 Revision Approved 10 01 2012 10 01 2012 10 01 2012 Sian this Package 1 New Project Modifications Required 10 01 2012 10 01 2012 10 01 2012 Delete this Package b You are currently viewing this package 7 Fill out and complete the IRB Continuing Review form a This can be obtained in the Forms and Templates section of IRBNet 8 Ifyou are making any modifications you will need to fill out and submit the Human Subjects Modification Amendments Form in addition the Continuing Review Form You must also include all necessary documentation see the Modifying an Approved Study page 20 of this manual for instructions 9 Click Add New Document near the middle of the screen a oy AN j Homes pe p 4 ae N gt N F pagr a Designer 383474 4 IRBNet Usability Study Step 1 Download blank forms document templates and reference materials to assist you in assembling your document package Select a Library Ball State University IRB Muncie IN _ ae Select a Document Child Assent Sample i e Download Step 2 Assemble your document package In addition to adding p
51. with IRBNet 14 Select the Share this Project link located on the left side of the page This is located under the Project Administration heading Project Overview i De iane Submit this R T Delete this Package Send Project Mail Project History 15 The following screen will appear and you select the first option Share 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 e 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 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 modi
52. yA Sign Package 2 the best of my knowledge the information contained in parli in accordance with all applicable institutional requirements and onic signature is intended to be the legally binding equivalent of a Charlie Cardinal as this package is accur is ready for submissig Administrative Reviewer traditional handwritten Advisor Associate Investigator Auditor Author Co Investigator se Signature Mode Department Head Department Representative Institutional Official Monitor Other Signato Principal Investigator Research Coordinator Scientific Reviewer Sponsor Statistician Sub Investigator Team Member To sign on behalf of a age has not been signed Forms and Templates 14 Your Annual Continuing Review is now ready to submit click Submit this Package under the Project Administration menu Sign Package 383474 4 IRBNet Usability Study Charlie Cardinal as Principal Investigator x certify that to the best of my knowledge the information contained in this package is accurate and complete has been prepared in accordance with all applicable institutional requirements and is ready for submission further certify that this electronic signature is intended to be the legally binding equivalent of a traditional handwritten signature To sign on behalf of another person switch to Designee Signature Mode This package has

IRBNet User Manual - Ball State University

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