University of Colorado Denver
Colorado Multiple Institutional Review Board
Standard Operating Procedures
SOP – Expiration Letters
Version #: 001
Effective Date: June 1, 2011
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 the timely expiration of protocols when the continuing review has not been
approved by the expiration date set at the previous continuing review.
2. POLICY: Any protocol that does not obtain approval by the continuing review date stipulated at the
previous continuing review will be expired in the database and the PI will be sent an expiration letter.
Specifically, when a protocol has expired on a Sunday, Monday, Tuesday, Wednesday or Thursday,
an expiration letter will be sent to the Principal Investigator on the day after expiration. When a
protocol expires on a Friday or Saturday, an expiration letter will be sent to the Principal Investigator
on Friday.
3. SPECIFIC POLICIES:
3.1. Step-by-Step Instructions:
3.1.1.
Create Report:
Program Tools
Reminders and Notifications
Enter Date Range
Continue
Determine Full Board and Expedited Protocols
Determine Expiration Date for each Full Board and Expedited Protocol
Determine Whether Protocol has Expired (Contact Panel or Expedited Coordinator)
3.1.2. Create Batch Communication:
Program Tools
Reminders and Notifications
Enter Date Range
Continue
Check Top 3 Boxes:
3.1.2.1.
Change the Protocol Status to: Expired
3.1.2.2.
Create a Submission Record:
Submission Type: Administrative
Review Method: Administrative Review
Review/Meeting Date: Today’s Date (Date of Sending Expiration Letters)
Description: Expiration Letter
3.1.2.3.
Create a Batch Communication: Expiration Letter
Check Mark All Applicable Protocols
Commit
Delete Duplicate Recipients: Set/Edit; Delete; Save; Back to List
Commit
Expiration Letters
CP-022, Effective 06/01/2011
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University of Colorado Denver
Colorado Multiple Institutional Review Board
Standard Operating Procedures
Check: All Send
Print Expiration Letters (2 Copies): File one Copy in Expiration Letters
Binder; Give 1 Copy to Panel/Expedited Administrative Assistant for Filing
Commit
Note: screen should say: Reminders and Notifications
Results 0 Protocols
if Expiration Letters were sent successfully
Note: Do Not Send Expiration Letters for WIRB, CIRB, Non-Affiliated and Exempt Protocols
3.2.
Weekday-Specific Instructions:
3.2.1.
3.2.2.
3.2.3.
3.2.4.
3.2.5.
Monday:
Create Report with Date Range Sunday and Monday
Send Expiration Letters for Protocols that Expired on Sunday
Tuesday:
Send Expiration Letters for Protocols that Expired on Monday
Wednesday:
Create Report with Date Range Tuesday and Wednesday
Send Expiration Letters for Protocols that Expired on Tuesday
Thursday:
Send Expiration Letters for Protocols that Expired on Wednesday
Friday:
Create Report with Date Range Thursday to Saturday
Send Expiration Letters for Protocols that Expire on Thursday, Friday and Saturday
4. RESPONSIBILITY:
It is the responsibility of the Regulatory Analyst, 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
Expiration Letters
CP-022, Effective 06/01/2011
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