Completing the Study Specific Worksheet

OVERVIEW

This Quickguide provides instructions for completing the Study-Specific Worksheet.

BEFORE YOU BEGIN

  • Consider printing a copy of the Worksheet by clicking here to use as reference as you complete the Worksheet in IRBManager. 
  • The Worksheet should be completed by the Principal Investigator (PI) or designee.

Deleting A Worksheet In IRBManager

OVERVIEW

This Quickguide explains how to find and delete a Worksheet associated with your Signatory Institution in IRBManager.  Completed and approved Worksheets can’t be deleted.  Only Worksheets currently in the initial completion Stage can be deleted using the steps listed below.  To delete a Worksheet from a later stage, please contact the

Algorithm to Assess Potential Noncompliance

OVERVIEW

This Quickguide provides an algorithm to assess whether or not an incident is reportable to the CIRB as potential noncompliance.

BEFORE YOU BEGIN

  • While reviewing the algorithm to assess potential noncompliance, the CIRB defines “serious” as noncompliance that adversely affects the rights and welfare of study participants or results in any untoward medical occurrence that meets the criteria of “serious” or significantly impacts the integrity of study data.

Submitting a Study for Continuing Review

OVERVIEW

This Quickguide provides Network Group coordinating office staff and Study Chairs with an overview of the continuing review process.

BEFORE YOU BEGIN

  • The Network Group coordinating office staff receives a reminder email  and access to the online continuing review application in IRBManager from the CIRB. The email and application indicates the study's expiration date and the application due date.

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