Jennifer Brown, RN, Director, Clinical Research Quality, Spectrum
Scott Patton, Manager, Clinical Trial Disclosure, Clinical Research Quality, Spectrum 

Register here:   http://bit.ly/CTR-5050

Target Audience

Research coordinators, nurses, faculty, staff and post-doctoral scholars conducting clinical research at Stanford.

Workshop Description

Come hear about the newly published Final Rule for FDAAA 801 – regulations for registration and results posting on ClinicalTrials.gov – and the new NIH policy on the dissemination of NIH-funded clinical trial information.

After attending this workshop, attendees will be able to:

•          Identify if a study is an applicable clinical trial (ACT) that requires registration & results posting
•          Identify if a study is an NIH-defined clinical trial (NIH-CT) that requires registration & results posting
•          Identify the effective date for the new regulations and policy
•          Determine whether the new or old rules apply to ongoing research
•          Summarize the differences between the old rules and the new regulations
•          Understand what resources at Stanford are available to support compliance

 Speakers

Jennifer Brown, RN, Director, Clinical Research Quality, Spectrum

Jennifer has over 25 years of experience in nursing, clinical education and research, medical device regulatory affairs and quality improvement, pharmaceutical training, medical and technical writing and editing.  Jennifer currently directs the newly formed Clinical Research Quality office in the School of Medicine, the purpose of which is to facilitate clinical research best practices and compliance.

 Scott Patton, Manager, Clinical Trial Disclosure, Clinical Research Quality, Spectrum 

Scott recently joined Stanford, bringing with him 10 years of industry experience in preclinical and clinical research. In the last 5 years, Scott has focused on clinical trials data disclosure and transparency, and has regulatory and practical expertise in ClinicalTrials.gov data reporting requirements.

 Additional “ClinicalTrials.gov” workshop dates:

• Monday, Nov. 7: 3:15pm – 4:15pm