University of ColoradoDenver

Colorado Multiple Institutional Review Board

Standard Operating Procedures

SOP –Continuing Review Notices

Version #: 001Effective Date: 05/01/11

This Policy Pertains to: Expired Protocols

Responsibility for executing this policy: IRB Manager, IRB Specialists, Coordinators

Last Reviewed on: 04/26/11Result: Approved

Approval Authority: Director

Approved by: Alison LakinDate:04/26/11

  1. PURPOSE: To ensure that the PI is given due warning that the continued review submission is due to be submitted to COMIRB.
  1. POLICY: At 75 days and 45 days prior to expiration a continuing review notice will be sent to the Principal Investigator unless the continuing review submission has already been submitted to COMIRB for review.
  1. SPECIFIC POLICIES:

Note: Send Continuing Review Notices on Monday, Wednesday and Friday

3.1. Step-by-Step Instructions:

3.1.1.Create Report:

Program Tools

Reminders and Notifications

Enter DateRange (Use Excel Spreadsheet for Specific Dates Pertaining to 75 Days and 45 Days Notices; Location: K Drive; Folder: CR Notices)

Continue

Determine Full Board and Expedited Protocols

For 45 Day CR Notices: Determine Whether Continuing Review Has Been Received

3.1.2.Create Batch Communication:

Program Tools

Reminders and Notifications

Enter DateRange (Same as Above)

Continue

Check Bottom 2 Boxes:

Note: Do Not Change Protocol Status (IRB Intake)

3.1.2.1.Create a Submission Record:

Submission Type: Administrative

Review Method: Administrative Review

Review/Meeting Date: Today’s Date (Date of Sending Continuing Review Notices)

Description: Continuing Review 1st Notice (for 75 Day Notices) or Continuing Review 2nd Notices (for 45 Day Notices)

3.1.2.2.Create a Batch Communication: Continuing Review 1st Notice or Continuing Review 2nd Notice

Check Mark All Applicable Protocols

Commit

Delete Duplicate Recipients: Set/Edit; Delete; Save; Back to List

Commit

Check: All Send

Check I Protocol to Confirm that Correct Letter was Built (View)

Commit

Note:screen should say:Reminders and Notifications

Results 0 Protocols

if CR Notices were sent successfully

Note: Do Not Send CR Notices for protocols when WIRB, CIRB, or a Non-Affiliated IRB are the IRB of Record. Also do not send CR notices for Exempt Protocols

  1. RESPONSIBILITY:

It is the responsibility of the Coordinators, IRB Specialists and IRB Manager to implement this SOP.

It is the responsibility of the Director and Assistant Director to implement and monitor this SOP.

  1. APPLICABLE REGULATIONS AND GUIDELINES:

45 CFR 46.103(b)(4)

21 CFR 56.108

6. ATTACHMENTS: None

Continuing Review Notices1 of 2

CP-021, Effective 5-1-2011