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eIRB Application Mistakes (Common Study Team Member Errors (Missing HSR,…
eIRB Application Mistakes
Common Study Team Member Errors
Missing HSR, COI, H&R, CRBO, recertification compliance training certificates/dates
Not adding or deleting study team members when submitting change applications
Not naming the study team members who have been added or deleted with a change in research application request
Changing the PI and but not deleting the PI as a study team member
Not revising the drug data sheet, recruitment material, consent form, and/or mid-level provider list to be consistent with study team member list changes
Reconciling the study team member list on investigator-initiated protocols and sponsor protocols
Common Document Upload Errors
Using the “add” function to upload revised versions of submitted documents
All recruitment material must contain the following: PI name, designation as PI, eIRB application number, and the term “research study”
All eforma and consent form documents must contain the following: PI name, eIRB application number, and current submission date
For sponsored protocol applications, the sponsor’s consent form is required for review
Check the irb website to ensure that you’re using the latest version of the form you are submitting
Purpose:
Common application processing errors can cost valuable research time. We want to help you to get it as right as possible the first time!
Scheduling Issues
Scheduling an eIRB application action can take up to 3-6 weeks depending on volume, time of year, staffing, and complexity of the research project.
“Normal scheduling time” is 2-4 weeks from the final PI submission date.
Facts About Returned Applications
99% of new applications are returned for corrections and/or clarification at least once.
70% of all change in research applications are returned for corrections and/or clarification.
Less than half continuing review applications, problem events, and termination reports are returned for corrections and/or clarification.
Common Drugs/Device Processing Errors
Not providing FDA documentation (e.g., IND exempt determination, study may proceed letters, 510k letters)
Not listing all protocolized drugs in the eIRB application
