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RESEARCH COMPLIANCE MATTERS RESEARCH COMPLIANCE WORKSHOPS Fall 2007/Winter 2008 Lecture & Workshop 11:45 to 1 p.m. LUNCH PROVIDED
DATE	ROOM	TOPIC	SPEAKER	DESCRIPTION
11/09/07 FULL	UTC 1 SUITE 155	Outside Consulting Agreements	Valerie Landrio McDevitt, JD, Director, Div. of Patents and Licensing/David Morgan, Professor of Molecular Pharmacology and Physiology	Guide to outside consulting agreements for faculty and academic employees; navigating NIH restrictions; avoiding waiver of University patent rights.
11/30/07	CMS 3048	Device Advice	Norma Epley, MS, CIP, Asst. Director, Research Integrity and Compliance	The FDA and IRB role in safeguarding rights and safety of subjects in medical device clinical studies. Responsibilities of investigators and investigator-sponsors explained.
12/14/07	CMS 3048	Clinical Curiosity: Developing Your Research Study	Katheryne Downes, MPH, Statistical Data Analyst, TGH	First steps in biomedical research: from formulating your hypothesis to planning a statistically sound study
1/11/08	CMS 3048	Navigating IRB Paperwork	Norma Epley, MS, CIP, Asst. Director, Research Integrity and Compliance	IRB processes and forms. Common mistakes in submitting an application.
1/25/08	CMS 3048	Evidence-Based Medicine	Ren Chen, MD, MPH, Biostatistics Core, College of Medicine	Have you ever felt like you're missing the point when reading a paper in a medical journal? If it's the statistics that are bogging you down, you're not alone.
2/08/08	CMS 3048	Clinical Trials Agreement	Corinne Walters, Clinical Research Administrator	Negotiating clinical trials agreements with sponsors; budgeting issues.
2/29/08	CMS 3048	Protecting Human Subjects	Norma Epley, MS, CIP, Asst. Director, Research Integrity and Compliance	Advanced human subject protection considerations including: Recruitment, informed consent, compensation of subjects, and use of vulnerable populations.
3/14/08	CMS 3048	Get Ready!	Caroline Fultz-Carver, PhD, Interim Director, Research Integrity and Compliance	Interactive look at preparation for a QA audit, audit process and response to audit.
3/28/08	CMS 3048	Research Protocols	Sadaf Aslam, MD, Medical Writer	Protocol drafting workshop; necessary elements to include for the IRB.

PLEASE RESERVE YOUR SPACE BY CALLING Charmaine Disimile 813.974.7715

Semi-monthly classes that will address individual questions regarding
research protocols and guidelines and other topics of interest
to faculty, students and coordinators.

Class size is limited to 7, please contact Charmaine to register.

Directions: Research Compliance Matters Workshops: CMS Building, 3048 13101 Bruce B. Downs Tampa, FL 33612
		..From I-75 N: Bear right onto off-ramp at exit 51 to Fowler Ave (SR-582 W). Proceed on Fowler Ave (SR-582 W) 4.1 miles. Turn right onto Bruce B. Downs Blvd., proceed 0.8 mile. Children’s Medical Services building is on your right. Come to the third floor; left off of elevator; second hallway to the left; first room on the right is 3048. From I-275 N: Bear right onto off-ramp at exit 51 to Fowler Ave (SR-582). Turn right onto Fowler Ave (SR-582) proceed 1.7 miles. Turn left onto Bruce B. Downs Blvd., proceed 0.8 mile. Children’s Medical Services building is on your right. Come to the third floor; left off of elevator; second hallway to the left; first room on the right is 3048.
Parking:If you have a USF E, H or Gold Staff hangtag, you may park in the E/H lots surrounding the CMS and COPH buildings. Note: It may be difficult to find a space in nearby lots during certain times of day.If you do not have a hangtag, please contact Charmaine Disimile at 974-7715 for parking instructions.

USF Health has at its core the colleges of Medicine, Nursing, and Public Health and the schools of Basic Biomedical Sciences and Physical Therapy. USF is one of only 95 public and private universities in the U.S. that have been designated as Carnegie Comprehensive Doctoral Research University/Very High Research Activity.

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