What's New at CPMC's IRBNew Version: Informed Consent Template (ICF) | New Reportable Events SOP
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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