November 13, 2008
OCR Course:
Conducting Clinical Research
Research Forums – Held quarterly for open discussion among Research Nurse/Coordinators; disseminate Forum Notes.
Work Shops – ad hoc for points of interest
FDA announces the availability of a draft guidance for industry entitled "Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting - Improving Human Subject Protection". http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf
The DHHS Office for Human Research Protections (OHRP) announces the availability of a new set of Frequently Asked Questions and Answers on Informed Consent on its website at: http://www.hhs.gov/ohrp/faq.html