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Working With the IRB-HSR

Getting Started Protocol Review Process

Managing Protocol After Initial Approval Special Issues




A Protocol Violation is any unapproved deviation from the protocol, GCPs, or IRB policies whether or not it is intentional and whether or not it is under the control of the Investigator.

Announcements

Continuation Review Dates
Have a question about when your protocol is due for continuation review? The next review date may be found by logging into IRB Online and clicking on IRB Schedule

Modification Update
Please remember that modifications requiring a change to the protocol and/or consent now require a pre-review.  Do not submit hard copies of your modification documents until you have received notification that your pre-review is complete.

Certain changes to a protocol will affect the templates you should use for the protocol and or consent.  For this reason- the full templates are now found on the website.  CAUTION:  These templates should ONLY be used for modifications to protocols already approved by the IRB.  A researcher must use Protocol Builder to write a new protocol or to complete the 5 year update.

Education
Several new learning shots have been posted to the website.

Save the Date:  October 13, 2008- Guest Speaker Gigi McMillan, Director, WE CAN Pediatric Brain Tumor Network and non-scientist member of UCLA IRB.  MR5- Room 3005 1:30-3:00 PM 

 

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