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Human Subjects Research Seminar: Current Regulations under FDA and HIPAA

Clinical Research: Foundation for the Application, Concepts and Theories

PRLog - June 24, 2014 - SAN FRANCISCO -- Overview:

This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. We will discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information.

Why should you attend:

For those involved in or wanting to be involved in research dealing with human subjects or an individual's private identifiable information, protection of human subjects and all that this topic encompasses is imperative to know as there federal regulations that must be followed. In addition to federal regulations, there are state statues, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research so that it not only meets the regulatory requirements but so that the study is conducted in an ethical manner containing adequate protections for the individuals who elect to enroll in the research or allow their information to be used for research. Guidelines also provide interpretation of the regulations which are not always as clear as they might appear upon first reading them.

Areas Covered in the Session:

Department of Health and Human Services regulations, 45 CFR 46
Office for Human Research Protections Guidance
The FDA regulations, 21 CFR 50, 56, 312, 314, 812, 814
HIPAA and Hi-Tech
ICH E6 Good Clinical Practices
Coercion vs. undue influence
Recruitment of Research Subjects
Vulnerable populations
Non-English speaking populations
Inclusion of Women and Minorities
Waivers of consent
Waivers of consent vs. waivers of authorization
Assent vs. consent
Wards of the State
Certificates of confidentiality
Levels of de-identification what they are and how they affect consent
Privacy vs. confidentiality
Study responsibilities: ICH vs. NIH
Drug/Device Accountability
Codes of Conduct
Conflicts of Interest
Reporting responsibilities
Investigator-sponsor responsibilities
Study types

Who Will Benefit:

Principal Investigators / Sub-investigators.
Clinical Research Scientists (PKs, Biostatisticians,)
Safety Nurses
Clinical Research Associates (CRAs) and Coordinators (CRCs)
Recruiting staff
QA / QC auditors and staff
Clinical Research Data managers
Human Research Protection professionals

About Speaker:

Sarah Fowler-Dixon,
PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institution

Date, Venue & Price:

Location : San Francisco | July 24th & 25th 2014| 8:30 AM to 5:30 PM

Venue:  Doubletree by Hilton Hotel San Francisco Airport
835 Airport Blvd, Burlingame CA 94010-9949

Price: $1,295.00

Register now and save $200. (Early Bird)
Until May 31, Early Bird Price: $1,295.00
From June 01 to July 22, Regular Price: $1,495.00

Event Coordinator:

Toll free: 800-385-1607

Fax: 302 288 6884

Email: support@mentorhealth.com

Event Link: https://www.mentorhealth.com/control/~product_id=200016SE...

Website: http://www.mentorhealth.com


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Location:San Francisco - California - United States
Industry:Event, Health
Tags:clinical research, human
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