Process Map for IRB Analysts

The below map is to be used after pre-review has been completed and after responses have been received from study team. If the Process (leftmost column) contains a link to instructions, then those instructions cover all the tasks under that process. If the Task (second column from left) contains a link to instructions, those instructions cover only that task.

Acceptance/Rejection Process

Pre-review Process

Action

Type of Submission

Process

Task

Full Board (approved)

Full Board (revisions required)

Exempt

Expedited (approved)

Expedited (RRSA)

Setup Micro Review Assign Offices
X
X
X
X
X
Proceed to Micro
X
X
X
X
X
Setup Review
X
X
X
X
X
Add Review
X
X
X
X
X
Select Review Type
Meeting Review
Meeting Review
Administrative
Member
Member
Select Review Process
Full-comittee Review
Full-comittee Review
Exempt - NCR
Expedited
Expedited
Send to Board Members and Put on Agenda Select the Board
X
X
 
 
 
Select the Meeting Date
X
X
 
 
 
Wait for non-PPHS Conditional Offices to Complete Reviews
X
X
 
 
 
Add and Send to Reviewer(s) X
X
 
X X
Wait for Micro Task to Display “Reviews Complete”
X
X
 
X
X
Send to Board
X
X
 
 
 
Send Agenda and Deferrable Issues
Create and Send Deferrable Issues X
X
 
 
 
Add Attendees, Build and Send Board Agenda X
X
     
Process Deferrable Issues and Close Board Micro Task
Wait for Deferrable Issues Communication from Study Team
X
X
 
 
 
Forward Deferrable Issues Response to Board Reviewers
X
X
 
 
 
Check that deferrable issues communications are saved in the micro task deferrable issues communications tab. X X
Close out Micro Task

Click "Submit"
  Process the Micro Task
Hold Board Meeting
Manage Meeting > Hold Board Meeting X
X
 
 
 
Post-meeting Cleanup
Return to Hold Meeting Task and Revise Notes and Minutes X
X
 
 
 
Process Meeting Decision
X
X
 
 
 
Process Board Decision Micro Task Appears for Analyst
X
X
 
 
 
Process Minutes from Meeting   X X      
Close "Hold Meeting" Task   X X      
Process Review Decisions
 
 
 
 
 
Set Motion


Acknowledged
Approved (enter Approval Start Date)
Revisions Required
Set Result
 

X
X
X
Determine Risk X   X X  
Determine Category
 
 
X
X
 
Confirm Action
Submit
Develop Response Submission
Submit
Submit
Develop Response Submission
  Finalize MICRO
 
Submit
 
 
Submit
Process Macro Task
 
 
 
 
 
 
 
 
 
 
Proceed to Macro
X
X
X
X
X
Setup Review
X
X
X
X
X
Add Review
X
X
X
X
X
Select Review Type
Administrative
Administrative
Administrative
Administrative
Administrative
Select Review Process
Administrative
Administrative
Exempt - NCR
Administrative
Administrative
Set Motion
Approved (enter Approval Start Date)
Revisions Required
Acknowledged
Approved (enter Approval Start Date)
Revisions Required
Set Result
X
X
X
X
X
Determine Risk X   X X  
Determine Category
 
 
X
X
 
Submit
Submit
Develop Response Submission
Submit
Submit
Develop Response Submission
Finalize MACRO
 
Submit
 
 
Submit

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