What's New at CPMC's IRBLast Submission Deadlines for 2013 IRB Review | New Version: Informed Consent Template (ICF) | New Reportable Events SOP
Last Submission Deadlines for 2013 IRB Review
Please note the following:
PROGRESS OR FINAL REPORT SUBMISSIONS:
If you have a study that will expire during the weeks of 12/9/2013 - 1/6/2014:
- If it is an Expedited study:
Please submit a progress or final report on or before Friday, December 6, 2013 to ensure that the study will be re-approved or closed in a timely manner and to avoid a lapse in IRB approval.
If it is a study that requires Full Board review:
Please submit according to the submission deadlines:
|Panel #||Submission Deadline||Meeting Date|
|2||Friday, November 8th||November 26th|
|1||Friday, November 22nd||December 10th|
ALL OTHER SUBMISSIONS:
Final date to submit for IRB review in 2013 is Friday, December 6, 2013. Items submitted after this date may not be reviewed until Monday, January 6, 2014.
Starting on Monday, December 16, 2013, the CPMC IRB will have modified hours of operation:
|Date||The hours of operation|
|Week of 12/16 - 12/20||Office Hours will be limited to 10am – 2 pm|
Limited processing of electronic submissions
|Week of 12/23 - 12/27||Office will be closed and not processing new submissions|
|Week of 12/30 - 01/03||Office will be closed and not processing new submissions|
Regular office hour and submission processing will resume starting January 6, 2014.
REPORTING REQUIREMENTS PER THE REPORTABLE EVENT SOP STILL APPLY.
If there is an Emergency Use, Emergent Modification, or Death of a CPMC Subject due to study drug during the time the IRB is closed:
- Please contact Lynne Day at 415 600 3014 or by email: DayL@cpmcri.org per the Reportable Event SOP.
IF YOU HAVE ANY QUESTIONS:
|Prior to 12/13||Please contact Angela Belluomini, IRB Manager at 415 600 3686 or by email: BelluoA@cpmcri.org|
|Week of 12/16 - 12/20||For IRBNet issues:|
Please contact Pernille Oland at 415 600 3586 or by email: OlandP@cpmcri.org
For IRB questions:
Please contact David Gill, IRB Administrator, Alta Bates Summit Medical Center, at 510 204 1414 or by email: GillD@sutterhealth.org
|Week of 12/23 – 01/03||Please contact David Gill, IRB Administrator, Alta Bates Summit Medical Center, at 510 204 1414 or by email: GillD@sutterhealth.org|
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New Version: Informed Consent Template (ICF)
There is a new REVISED version of the CMPC ICF template available in the Forms and Template library in IRBNet.
If you are submitting a new study please make sure you are using this new version of the template. For on-going studies, the mandatory language should be included when a revised ICF is being submitted as a modification. If you have any questions, please feel free to contact the IRB office 415-600-3688.
Of note: There is revised language which is mandatory regarding CPMC’s Conflict of Interest Policy.
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New Reportable Events SOP
The CPMC IRB has approved a NEW Reportable Events SOP:
Principal Investigators Reporting Requirements.
This SOP explains the types of events that need to be reported to the IRB and can be found in the “Forms and Templates” library in IRBNet.
In addition to the new SOP, the IRB also has four new forms and two revised forms.
- Unanticipated Problem Report
- Unanticipated Adverse Device Effect (UADE)
- Emergent Modification 5 Day Report
- Reportable Events Summary
- Adverse Events Report
- Protocol Violation Report
How to find the IRB Standard Operating Procedures & Forms in IRBNet:
Please login to www.irbnet.org.Opens new window with your username and password. Click “Forms and Templates” on your left hand menu for a listing of, and access to, the latest version of all available Standard Operating Procedures & Forms.
- updated October 2013
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