Clinical Research CoordinatorCourse 2 of 8

Clinical Research Coordinator

Full course · Study Start-Up and Site Activation

IRB/IEC initial submission packages: assembling the complete application — Study Start-Up and Site Activation

IRB/IEC initial submission packages: assembling the complete application

Prepare a complete IRB/IEC initial submission package including all required supporting documentation, and implement a tracking system to prevent common return reasons.

25 min

You submitted Monday. You got it back Thursday.

The coordinator submitted the IRB application on Monday morning. Complete, or so it seemed. The protocol was there. The consent form was there. The investigator's CV was there. Everything looked right.

Thursday afternoon, the IRB coordinator emailed a list of deficiencies. Three items missing, two items outdated, one form not completed. The application was returned without review.

Three working days lost. Not because the science was wrong. Not because the protocol had safety concerns. Because the submission package was incomplete.

This scenario plays out at research sites across the country with dispiriting regularity. In my experience reviewing site regulatory files, IRB return-without-review is one of the most preventable delays in the entire start-up timeline--and one of the most common. The reason is almost never that the coordinator did not know the study needed IRB approval. The reason is that assembling a complete initial submission package requires attention to a dozen components simultaneously, each with its own version requirements, formatting expectations, and institutional idiosyncrasies. Miss one, and the package comes back.

This lesson is about not getting it back. It covers what goes into a complete initial submission package, how to prepare each component correctly, how to track the submission through the review process, and how to conduct a pre-submission self-audit that catches the deficiencies before the IRB does.

What you will learn4 objectives

By the end of this lesson, you will be able to:

Identify all components of a complete IRB initial submission package: protocol, Investigator's Brochure, consent form, HIPAA authorization, recruitment materials, questionnaires, investigator CV, financial disclosure, and institutional forms
Prepare each component with correct version verification, formatting, and institutional-specific requirements
Implement a submission tracking system to monitor application status, reviewer questions, and required revisions
Execute a pre-submission self-audit that prevents the most common return reasons

Progress saves itself — finish reading and this lesson completes

This is just the beginning

You submitted Monday. You got it back Thursday.