Study Teams

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eiRB

§  Registration   §  New  Studies   §  Continuing  Reviews   §  Amendments   §  Reportable  Events   §  Tips  &  Tricks   §  Questions  

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ARC:  Electronic  IRB  System   §  ARC  (Applications  for  Research  Compliance)    

ú Electronic  system  which  houses  eIRB,  eIACUC  and  eCOI  applications  

     

§  USF  IRB’s  electronic  system:  

ú Study  Teams:  Complete  and  submit  IRB  applications  and  subprojects  

 

   

 

     

(Continuing  Reviews,  Amendments  &  Reportable  Events)  

ú USF  Departments  &  USF  Affiliates:  Issue  departmental  level  approvals   ú Institutional  Review  Board:  Process    and  review  applications,  

communicate  with  study  teams,  and  issue  final  approvals  

§  Electronic  regulatory  file  

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Registration  

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Getting  Started:  Registration   §  To  access  and  use  ARC,  you  must  register:   ú https://arc.research.usf.edu/prod   ú Quick  links  are  available  on  the  ORI,  RIC  and  IRB   homepages  

 

 

     

§  Complete  all  the  fields  on  the  registration  form   ú Your  name,  e-­‐mail  address,  phone  number,  department   name,  etc.  (please  avoid  using  abbreviations)   ú Request  your  user  Roles  

 

     

§  Your  User  Name  and  Password  will  be  e-­‐mailed  to  you.  

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ARC  Homepage  

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Registration  Form  

Items  marked  with  a  

*  

are  required  fields  

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My  Home  

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Inbox   Lists  all   applications   that  require   action  by  you   or  other  staff   on  your  study   team  

*  If  an  item  is  in  your  Inbox,  it  still  requires  your  attention*   9  

New   Studies  

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Create  a  New  Study   §  1)  Complete  SmartForm   ú Study  team  answers  questions  providing  details  about  their        

research  proposal  

 

§  2)  Team  Members  Agree  to  Participate   ú The  PI  and  all  study  personnel  answer  questions  related  to  conflict   of  interest  before  the  application  can  be  submitted  

 

         

§  3)  Submit  Study  

 

ú Only  PI  can  submit  Study  

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Create  a  New  Study  

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Smart  Form  Navigation   Does  Not  Save  

Saves  Application  

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Smart  Form  Navigation   in-­‐form   “Jump  To”  navigation  

Current  Page  

Required  Pages  

Not  Required  Pages  

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Study  Team  Roles   §  PI  –  create  and  edit  applications,  respond  to  requested  

revisions,  submit/withdraw  applications  

§  Study  Coordinator  (s)  –  create  and  edit  applications,  respond  to  

requested  revisions,  submit/withdraw  applications  

ú Cannot  submit  the  study  until  the  PI  has  submitted  it  initially   ú Can  now  have  up  to  2  coordinators  on  a  study  

§  Co-­‐Investigator(s)  –  create  and  edit  applications,  respond  to  

requested  revisions  

ú Cannot  submit  or  withdraw  

§  Key  Personnel–  view  only  access  

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Study  Team:  Role  Selection   §  Trouble  finding    

 

someone?  

ú Usually  indicates  

they  are  not   registered   ú They  may  not   have  the   appropriate  role  

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Study  Team:  Education  &  CVs   §  The  PI’s  CV  and   education  shows  at   the  top.   §  Certification  not   current  will  need  to  be    

updated.  

     

§  CVs  can  be  uploaded   through  an  activity  or   Agree  to  Participate.  

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Study  Team:  Education   §  Human  Subject  Protection  Education   ú Any  individual  directly  involved  in  the  conduct  of    

clinical  or  social  and  behavioral  research  must  have   current  training   ú Not  Current  education  will  hold  up  approval  but  not   submission  

§  Completed  through  CITI  Program  

 

ú https://www.citiprogram.org   ú Courses  are  valid  for  two  years   ú Valid  courses  detailed  on  ARC  Homepage  

ú Either  Basic  or  Refresher  courses  will  satisfy  the  

IRB  Education  requirement.  

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SmartForm  Application   SmartForms  branch  to  the  appropriate  pages  based  on  your   selections  

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Documents  in  eIRB  

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eIRB  Application  –   Final  Smartform  Page  

 

Clicking  Finish  or  Exit  will  bring  you  to  the  Study’s  Workspace  

 

*** Clicking  Finish  does  NOT  submit  your  study!!!***   21  

Study  Workspace  

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Study  Workspace   §  The  top  section  shows  the  Current  State  

of  the  study  and  the  various  ways  you   can  view  the  application.  

§  My  Activities:  Use  these  to  move  the  

application  through  the  review  and   approval  process.  

§  The  activities  available  will  vary  

according  to  the  role  you  have  on  the   study  and  the  “State”  of  the  study.  

§  Upload  Team  Member  CV:    Upload  CV  

to  profile,  only  have  to  upload  once.  

§  Upload  Team  Member  Education  

Certification:  Upload  education   certificates,  dates  will  be  updated  by   IRB  office.   23  

Study  Workspace   §  The  study’s  title  and  Pro-­‐  

number  can  be  found    to   the  right  of  the  workspace.  

§  The  History  tab  will  show  

all  activities  completed  on   the  study.  

§  The  Attachments  tab  will  

show  all  sections  where   attachments  can  be  made.  

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Study  Workspace   The  study  workspace  is  displayed  when  you:   1.  Select  Exit  or  Finish  in  the  SmartForm  ,  or…  

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Study  Workspace   ...when  you:   2.  Select  your  application  from  your  homepage,  or  

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Study  Workspace   …when  you:   3.  Select  the  application  link  from  an  email  notification  

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Agree  to  Participate  

This  will  send  an  email  to  all  Study  Team  members.  This  activity  can  be  repeated  if  necessary.  

Include  custom  message  to  study  team   members  here.  

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Agreement to Participate: • As a member of the study team,Iunderstand that I have responsibilities related to the conduct and oversight of this research study. II with all documents that comprise this submission. Iwill ensure this research study is conducted in accordance with the ethical principh institutional policies,and federal and state regulations. 0Yes 0No Clear

Pre Submission

Ll:] Edit Study

J ( Printer Version rl.,-,'"'· V-ie_w_ S_m_art_F_orm Pro_g_r_ess- -.,J  

Conflict of Interest Disclosure 1.) Do you or an immediate family member hold equity interest in, receive personal compensation from,or have a business relationst as officer,director,partner,trustee,board member, scientific advisory board member,etc) with an entity (e.g.,the sponsor, provic being investigated or equipment/services being offered, or the holder of any ownership interest in a product being investig "";earch outlined in this proposal? 0Yes 0No Clear 2.) Do you or an immediate family member have a proprietary interest (including trademark, patent,copyright, licensing agreement o orcmertv lassociated with the research outlined in this proposal (e.g., the drug or device)? 0Yes 0No Clear

If you have answered yes to either of the questions outlined above, please upload evidence of your institutions acknowledgement, r is conflict of interest (i.e., the conflict of interest management plan).

you have answered yes to quesltons 1 and 2 above, and have not submitted your CO/ disclosure,please go to hltps.llarc .research .usf.edu/Prod It and obtain a management plan.

 

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Agree to Participate and

r;tl Withdraw Study (SSl Edit Email List

to employ a related person in a paid capacity on this research project, you must complete the COl dtsclosure   form at h ps f/8/c.r• search.ust edu/Prod to teporl nepotism in research. note that finai/RB approval will not be gtanled until /he IRB receives a conflict olinterest management plan or other document from your ins institutioo• awareness and management olthe conflict. In addition, if during the course olthe study should you acqwe a finanCial mteresl or enter 1 relationship (as ou/Jmed abow1) wh1ch has not been previously disclosed to the /RB, it is your responsibility to notify the IRB v1a an amendment.

Edit Guest List

fSsl Upload Tearn Member CV

f Biosketch

Please attach your current CV/Biosketch here. If it is already current,there is no need to replace it: CV HERE(O 02) I Uplood Revision II Oelete I

[Ssl Upload Team Member Education Certificat ion

To  Submit  the  Study  

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Submit  the  Study  

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Study  Submitted   §  Two  ways  to  ensure  the  application  was  submitted:    

1.  The  state  of  the  study  has  changed  from  Pre  Submission  

2.  Under  the  History  tab,  you  will  see  a  new  activity  listed  

that  shows  PI  Submitted  Study  

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The  Path  to  IRB  Approval   Pre   Submission  

Affiliate/   Department   Review  

IRB  Review  

Approval  

§  After  the  PI  has  submitted  the  application,  it  is  routed  to  the  

     

next  states   §  The  study  team  will  receive  email  notifications  when  the   application  requires  their  attention   §  Please  Note  :  The  study  is  not  officially  approved  until  you   have  received  the  IRB  Approval  Letter!  

 

At  any  point  in  this  process,  you  can  log  in  to  ARC  to  see  where   your  eIRB  application  is  on  the  path  to  approval!  

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Requested  Revisions   §  Reviewers  may  request  revisions  or  additional  information  at  

each  stage  of  this  process  

§  The  application  will  return  to  the  study  team’s  Inbox   §  Study  teams  respond  to  these  concerns  via  ARC.   · Responding  to  concerns  is  a  3  step-­‐process:  

1.  Correct   2.  Respond   3.  Submit   34  

Requested  Revisions  

§  Click  the  Reviewer  Notes  tab  in  the  study  workspace  to  see  

all  the  notes  that  were  added   §  Click  the  Jump  To  link  to  take  you  to  the  page  of  the   application  where  the  requested  change  needs  to  be  made  

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Requested  Revisions   STEP  ONE:   §  Read  the  Requested  

Change  placed  on  the   page  of  the  question.  

§  Complete  the  request  

on  the  application.  

ú If  a  revised  document  

needs  to  be  uploaded,   use  the  Upload   Revision  button.   36  

Requested  Revisions    

STEP  TWO:  

   

§  Respond  to  the  

Reviewer  Note!   ú Your  response  will  

 

turn  green  

     

§  Some  changes  may  

add  new  pages   with  questions  that   need  to  be   answered.   ú Click  Continue  

through  the  rest  of   the  application  

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Requested  Revisions   STEP  THREE:  

 

§  Once  all  changes  have  been  made,  Save  and  Exit  the  

application.  

 

ú You  will  return  back  to  the  Study  Workspace.  

§  Under  My  Activities,  click  on:    

Submit    Requested  Revisions  or  Information,  

§  Then  click  ‘Ok’  in  the  resulting  dialog  box.  

This  moves  the   application   back  to  the   person  who   requested  the   revisions   38  

Changes  Submitted   §  The  state  has  returned  to  Department,  Affiliate  or  IRB  Staff  

Review   §  Under  History,  you  can  see  the  amount  of  logged  changes,  by   whom  and  the  date  and  time  the  revisions  were  submitted.  

 

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Approved  Study  Workspace  

To  find  your  approved  study:  

 

§  From  My  Home  or  from  IRB  Studies  at  the  top  of  the  page,  click  on  the  Approved  Studies  

tab.  

§  Find  the  appropriate  study  and  click  on  the  title  to  reach  the  study’s  main  workspace.  

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Approved  Study  Workspace  

In  the    Study’s  Workspace  you  will  find:   1.  the  approval  letter,   2.  the  attachments  tab  with  approved  

documents,   3.  additional  applications  to   be   filled  out   (amendments,  Reportable  Events   and   Continuing/Final  Reviews).  

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Study  Subprojects  

All  subprojects  use  SmartForms  and  require  IRB  Review  and  Approval  

   

 

ú Continuing  Reviews   ·  request  an  extension  of  your  study’s  approval  period   ú Amendments   ·  allow  you  to  make  changes  to  the  approved  study   ú Reportable  Events   ·  are  used  to  notify  the  IRB  of  incidents  that  require  IRB  review   42  

Only  One  at  a  Time   §  You  can  only  have  one  Amendment  or  Continuing  Review  

opened  at  a  time.  

§  Reportable  Event  applications  can  be  created  and  submitted  

at  any  time.  

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Continuing   Reviews  

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§ 

Notes  about   Submitting   Continuing   R eviews   No  changes  to  the  study  can  be  made  at  the  time  of  

continuing  review.  

ú An  amendment  will  need  to  be  submitted  and  approved  prior    

to  or  after  the  Continuing  Review  has  been  opened  and   completed  (approved,  disapproved  or  withdrawn)  

§  Ensure  that  the  human  subject  protection  education  

requirements  are  up  to  date  for  all  study  team   members.  

ú You  can  use  the  Upload  Team  Member  Education  Certification    

activity  at  any  time  to  upload  certificates.  

§  Reminder  notices  are  sent  out  automatically  from  the  

system  60,  45,  and  30  days  from  expiration.  

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Submitting  the  Continuing  Review  

§  You  will  continue  to  receive  reminder  notices  from  the  

system  until  the  Continuing  Review  has  been  submitted.  

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Amendments  

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Notes  about  Submitting  Amendments   §  You  can  use  one  Amendment  to  make  all  necessary  changes.   ú If  you  are  adding  Key  Personnel,  they  will  need  to  Agree  to  Participate  before  

 

you  can  submit.   ú If  you  choose  Other  Changes,  in  addition  to  completing  the  Amendment  form,   you  will  need  to  make  the  necessary  changes  in  the  main  application.  

     

§  Amendments  are  routed  directly  to  the  IRB  for  processing.  

 

ú If  a  new  PI  from  a  different  department  is  being  added,  then  it  will  go  through  

the  department    or  affiliate  review  first.  

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Select  Changes  

§  The   first   page   of   the  Amendment   will  ask   the  

types  of  changes  you  are  making  and  for  brief   description.  

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“Other  Changes”  selection   §  Instructions  and  a  

quick  guide  to  the   sections  (in  the   approved  study)   that  are  commonly   changed  are  listed.  

§  To  reach  the  

approved   application  to  make   changes,  click  on   the  link  provided.  

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Submitting  the  Amendment  

After  you  click  Finish,  you  will  exit  the  form  and  will  be  directed  to  the  Amendment   Workspace.   If  you  added  study  team  members,  use  the  Notify  Team  Member  to  Agree  to  Participate   activity.   51   After  all  agreements  are  received,  use  the  Submit  Amendment  activity.  

 

Reportable   Events  

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Notes  about  Submitting   Reportable  Events   §  Reportable  Events  can  be  created,  even  if  an  Amendment  

or  Continuing  Review  is  opened  and  pending  approval   §  Submission  Types:   ú Unanticipated  Problem   ú Data  Safety  Monitoring  Report   ú Protocol  Violation/Deviation   ú Breach  of  Confidentiality   ú Noncompliance   ú Other  

 

 

 

 

 

 

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Opening  a  Reportable  Event  

 

The  Approved  Study  Workspace  

 

The  Reportable  Event  application  is  still  available   even  though  a  Continuing  Review  is  opened.  

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Reportable  Events  Smartform  

Proceed  through  the  application  smartform  just  like  in  the   other  projects.  The  form  will  branch  as  necessary.   55  

Submitting  a  Reportable  Event  

When  finished  with  the  form,  remember  to  use  the  submit   activity  to  send  it  to  the  IRB  for  review.  

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Tips  & Tricks  

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Forgot  Login  Credentials?  

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What’s  My  Status?   Option  1:  From  My  Home  Workspace   §  Login  to  ARC   §  Use  the  

navigational   tabs  to  filter  

§  Click  on  the  

name  of  your   study  

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What’s  My  Status?   Option  1:  From  My  Home  Workspace   §  Once  on  the  study’s  main  workspace,  the  current  state  will  display  in  the  

red  box  on  the  left.  

§  Use  the  tabs  to  find  subprojects  (Continuing  Reviews,  Amendments,  

Reportable  Events)  

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What’s  My  Status?   Option  2:  From  IRB  Studies  tab   §  Click  IRB  Studies  at  the  top  of  the  screen   §  Initial  studies  are  automatically  shown  in:  In  Progress,  Approved,  and  

Archived  (Completed  or  Withdrawn  studies)  tabs.   §  The  status  is  viewable  in  the  State  column   §  The  Name  column  will  have  a  link  to  the  subproject  workspace  for  

more  details.  

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What’s  My  Status?    

Option  2:  From  IRB  Studies  tab  

 

§  You  can  also  click  under  Other  Submission  Types  to    show  

a  list  of  those  applications.   §  You  can  check  the  state  in  the  In  Progress  tab  or  click  on   the  Name  link  to  reach  the  application’s  workspace.  

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Important  Tips   §  All  applications  must  be:   ú 1)  Completed  (SmartForm)  

 

ú 2)  Submitted  (Activity)  

ü ü

§  If  an  application  is  in  your  Inbox,  it  still  requires  your  attention.   §  Remember  to  Save:  

 

 

ú Save  or  Continue  saves  your  changes   ú Back  and  Exit  do  not  save  

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§  Access  to  ARC    

ú Official  regulatory  site:  https://arc.research.usf.edu/Prod  

   

 

ú Need  Help?  Contact  the  ARC  HelpDesk:   ú 813-­‐974-­‐2880  between  8  AM  -­‐  5  PM  Monday  through  Friday  

 

§  Access  to  training  

 

 

ú Demo  Site  for  training  and  practice:  

https://arcdev.research.usf.edu/Sandbox   Login:  pi  Password:  1234  

   

ú Need  to  schedule  a  training?  

Contact  the  IRB  Office  at  (813)  974-­‐5638   64  

ARC  Helpdesk:   Email:  RSCH-­‐[email protected]:  

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