Research Affairs would like to invite you to the February 9 Lunch Seminar:

Student and Volunteer Access to the Electronic Medical Record for Research Purposes

Getting the right people access to the medical record system is often critical to keep research moving forward. This can certainly be the case when bringing on a student or volunteer to help with a project.  Or, if you are involved with student research, you know the importance of data access for their study timetables.  Understand the issues and obstacles better which enjoying lunch, in this next installment of the Research Affairs Noontime Seminar program.  See flier for details.

The program will be held in the Research Affairs main conference room from 12-1pm. Physicians attending this session will earn CME. 

You must register to receive credit and so we can have lunch ready for you. Seating is limited.

 Please click link  Register    

Also, attendees who submit an evaluation form after the program will be entered into a drawing for a $25 gift card.  Congratulations to Yoly Magana for winning the drawing for a $25 gift card at the last seminar

• The U.S. Food & Drug Administration (FDA) found that a California investigator persistently failed to ensure that a number of his research subjects fulfilled enrollment inclusion criterion.  FDA’s Warning Letter suggests that the physician attempted to change subject enrollment data months after actual enrollment.

• The Office of Human Research Protections investigated a major medical center in New York and found that researchers changed the informed consent before getting IRB approval.  Investigators suspended enrollment for two affected studies until revisions were approved by the IRB.

If you need clarification about avoiding Protocol Violations or how to prospectively obtain a protocol exception from the IRB, call Anu Diekmann at x86215.