Passport Series for Clinical and Translational Research
The Passport Series for Clinical & Translational Research is co-sponsored by the TRP, CRP, & Research Administration in collaboration with the Committee on Clinical Investigation (CCI), and Education and Quality Improvement Program (EQuIP).
Data and Safety Monitoring: Boards v. Plans? What do I need for my study?
Thursday, December 2, 2010 from 3pm - 4pm, Karp 7
PRESENTER: Adam Simmons, MPH
Ten Questions Every Investigator Should Ask BEFORE Doing Research on Drugs, Devices or Biologics
Thursday, November 4, 2010 from 3pm - 4pm
PRESENTERS: Matt Wladkowski, MS & Adam Simmons, MPH
Presentation Slides - 11.5.09
Regulatory Affairs - Key Contacts Sheet
The 10 Questions Every Clinical Researcher Should Ask BEFORE Doing Research With a DRUG or DEVICE
This session discusses investigator responsibilities and various resources at CHB that can facilitate clinical and translational research. Breakfast will be provided. Participants are introduced to federal requirements for studies involving drugs, devices and biologics. At the end of the session, participants will understand when they need an IND or IDE, as well as support resources for research available at CHB. Following the presentation, there is a meet and greet session with various officers across the hospital, including Regulatory Affairs who can aid with IND/IDE applications, CRP, CCI (IRB), EQuIP, CTO, CTSU, Research Pharmacy, and Research Nursing.
All clinical, translational and basic researchers who are or may be planning studies involving patients or patient samples at Boston Children's Hospital.
This event is co-sponsored by the Translational Research Program (TRP) and the Clinical Research Program (CRP) in collaboration with the Education and Quality Improvement Program (EQuIP), Clinical Trials Office (CTO), and the Technology and Innovation Development Office (TIDO) at Boston Children's Hospital.
Please contact the Translational Research Program or by phone at 4-2927.
*** Please check back for Winter 2012 dates or email TRP@childrens.harvard.edu to join the announcement list for future sessions.