University of Colorado Denver
Colorado Multiple Institutional Review Board
Standard Operating Procedures
SOP – Continuing Review Notices
Version #: 001
Effective Date: 05/01/11
This Policy Pertains to: Expired Protocols
Responsibility for executing this policy: IRB Manager, IRB Specialists, Coordinators
Last Reviewed on: 04/26/11
Result: Approved
Approval Authority: Director
Approved by: Alison Lakin
Date:
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.
2. 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.
3. 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 Date Range (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 Date Range (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
Continuing Review Notices
CP-021, Effective 5-1-2011
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University of Colorado Denver
Colorado Multiple Institutional Review Board
Standard Operating Procedures
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
4. 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.
5. APPLICABLE REGULATIONS AND GUIDELINES:
45 CFR 46.103(b)(4)
21 CFR 56.108
6. ATTACHMENTS: None
Continuing Review Notices
CP-021, Effective 5-1-2011
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