Clinical Research Operations Update From Lindsey Criswell, Vice Chancellor of Research

Clinical Research Operations Update From Lindsey Criswell, Vice Chancellor of Research June 2018

Implementation of Revised Common Rule is Delayed

What’s happening?

New IRB Form for Enrollment Exception Requests

The IRB has created a new “Protocol Enrollment Exception Request” submission form and it is now available in iRIS. When do I use the Protocol Enrollment Exception Request form?

HRPP Update from Brian Smith: Assoc. Vice Chancellor, Interim Chief Ethics & Compliance Officer

The message below is sent on behalf of Brian Smith, Associate Vice Chancellor, Interim Chief Ethics and Compliance Officer Dear Research Community,

iRIS System Downtime – Sunday November 19th from 7am to 2pm

The iRIS system will be taken offline this Sunday the 19th for an upgrade to the next version of iRIS. Please log off prior to 7am PST to avoid losing work. The maintenance window is scheduled from 7am – 2pm. The upgrade could be completed earlier. We’ll send a message out once the system is back...

IRB Studies Expiring in December and January

Please note that there will be fewer IRB meetings in December and January. If your study is set to expire in December or January, please submit your continuing review well in advance. Meeting dates can be found at the following link: http://irb.ucsf.edu/irb-rosters-meeting-dates

NIH Single IRB Webinar

The webinar is intended for Principal Investigators, Signing Officials, Offices of Sponsored Research, and Institutional Review Boards (IRB). The webinar will cover: Background Implementation process Expectations Process to request exceptions to the policy Responsibilities of the single IRB...

Report Potential Breaches of Privacy or Confidentiality Within 48 Hours

Potential breaches of privacy or confidentiality of study participants’ Protected Health Information (PHI) are considered “major (reportable) incidents” that must be reported to the HRPP/IRB. The IRB collaborates with the UCSF Privacy Office to investigate these incidents to meet state and federal...

IRB Leadership Change

Sent on Behalf of Associate Vice Chancellor Theresa O’Lonergan

iRIS System Downtime 7:00-7:30pm on Wednesday, 2/15/17

The iRIS system will be taken offline briefly tonight between 7:00pm and 7:30pm for a critical patch. Please log out of the system prior to 7pm to avoid losing any work.   We apologize if this downtime causes inconvenience to any users. We try to schedule maintenance activities during typically...