Human subjects protection by MentorHealth

MentorHealth

Net Zealous

We Train Healthcare Professionals

2-day In-person Seminar:

Human Subjects Protection - Two Day Seminar By: Sarah Fowler-Dixon, Education Specialist and instructor , Washington University

Location: San Francisco | July 24th & 25th, 2014 Location: Miami | September 18th & 19th, 2014 Course "Human Subjects Protection - Two Day Seminar " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertiﬁcation upon full completion.

MentorHealth is a comprehensive training source for healthcare professionals. Our trainings are high on value, but not on cost. MentorHealth is the right training solution for healthcare professionals. With MentorHealth, healthcare professionals can make use of the best benefits relating to their professional training. • They can get the benefit of advice from experts in the field. • Healthcare professionals will have the flexibility of viewing recorded webinars at their convenience. • MentorHealth offers online interactive participation. Using this, healthcare professionals, no matter which part of the world they are based in, will have the opportunity to listen to and interact with some of the most accomplished experts in the healthcare Industry. MentorHealth is driven by a core objective –that of being a platform for learning and discussion to address some of the

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important issues and challenges that the healthcare community, consisting of healthcare workers from doctors to nurses to other support staff, is up against in today‘s scenario. Various aspects of healthcare, such as Meaningful Use, Patient Protection and Affordable Care Act of 2010, HIPAA, HITECH Act, Stark and Anti Kickback Act, Valid Consent, Patient Safety and Process Improvement, Patient Safety and Quality Outcomes, Healthcare Information Technology Standards Panel (HITSP), Substance Abuse and Mental Health Records, Nursing Informatics, Healthcare Disclosure, Electronic Transactions Standards such as 5010 and ICD-10, Electronic Health Records, Stimulus Code, Healthcare Information Exchange, Healthcare Information Technology, Medical Necessity, Personal Health Records, Clinical Decision Support, Financial Management and ROI, Electronic Prescribing, Healthcare Information Systems, Clinical Informatics, Insurance Claim Appeals, Auto ID and Bar Coding, Integration and Interoperability, Risk Management in the Retention and Destruction of Medical Records and Medical Records Law, to name just a few, are covered.

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MentorHealth

2-day In-person Seminar 2014

We Train Healthcare Professionals

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.

Sarah Fowler-Dixon Education Specialist and instructor , Washington University

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 institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook. Prior to joining Washington University, Dr. FowlerDixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.

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. This information can then be used to help attendees in their day-to-day decision making when confronted with situations or questions regarding how to handle issues that do arise (e.g. a participant not showing for a scheduled appointment. Course Outline: FIRST DAY

SECOND DAY

Lecture 1: The Evolution of Human Experimentation Regulation and Overview of Clinical Research and Ethics in Human Research

Lecture 8: Multisite, Community and Collaborative Studies Lecture 9: The Institutional Review Board

Lecture 2: Current Federal Regulations and Agencies involved in Human Research

Lecture 10: Patient Safety in Clinical Trials Research

Lecture 3: Selection and Recruitment of Research Subjects

Lecture 11: Research Under the Food, Drug & Cosmetic Act

Lecture 4: Informed Consent in Clinical Trials

Lecture 12: International Research

Lecture 5: Conﬁdentiality of Clinical Trial Information

Lecture 13: Compliance and Human Research

Lecture 6: The Investigator

Lecture 14: Accreditation and Risk Management in Clinical Trials

Lecture 7: Research Protocols

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All rights are reserved © MentorHealth.

MentorHealth

2-day In-person Seminar 2014

We Train Healthcare Professionals

Pricing list: Price for One Delegate pass Price: $1,295.00 San Francisco | July 24th & 25th 2014

Miami | September 18th & 19th 2014

Until May 31, Early Bird Price: $1,295.00

Until july 15, Early Bird Price: $1,295.00

From June 01 to July 22, Regular Price: $1,495.00

From

July 16 and September 16, Regular Price: $1,495.00

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

What you get

Payment Options:

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 Credit Card: Use the Link to make Payment by

6. 7. 8. 9.

Learning Objectives Participation certificates Interactive sessions with the US expert Post event email assistance to your queries. Special price on future purchase of web based trainings. Special price on future consulting or expertise services. Special price on future seminars by MentorHealth. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. Networking with industry's top notch professionals

Visa/Master/American Express card click on the register now link  Check: Kindly make the check payable to NetZealous

DBA MentorHealth and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA  PO: Please drop an email to

support@mentorhealth.com or call the our toll free +1-800-385-1607 for the invoice and you may fax the PO to 302-288-6884  Wire Transfer: Please drop an email to

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Who Will Benefit: 

Principal Investigators / Sub-investigators.

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Clinical Research Scientists (PKs, Biostatisticians,)

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Safety Nurses

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Clinical Research Associates (CRAs) and Coordinators (CRCs)

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Recruiting staff

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QA / QC auditors and staff

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Clinical Research Data managers

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Human Research Protection professionals

Contact Information: Event Coordinator Toll free: +1-800-385-1607 Fax: 302 288 6884 Email: support@mentorhealth.com

Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar Team MentorHealth

NetZealous LLC, DBA MentorHealth 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

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MentorHealth

2-day In-person Seminar 2014

We Train Healthcare Professionals

Registration Form: Please use this form to register online, using your American Express, Visa or MasterCard. To get discounts on group attendance, please call us on 1800 425 9409 Call us on +1-800-385-1607 or fax your PO to 302 288 6884 Please pay your check issued from the payee to NetZealous LLC, our parent company, and mail it to NetZealous, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Please call us at 800-385-1607 or email us at support@mentorhealth.com Please ﬁll this form out and include attendee and payment details in it and fax it to 302 288 6884

Terms and Conditions Your registration for this seminar is bound by terms and conditions spelt out here. Please call or mail us if you have any clariﬁcations or doubts on this issue.

Cancellations and Substitutions If you wish to cancel your attendance at our seminar, the person who has registered for this seminar has to submit written cancellations through fax or email at least 10 calendar days before the date of commencement of the event. This will entitle her/him to a full refund minus a $150 administration fee. No cancellation request will be accepted or entertained and no refunds will be issued for requests made outside the stipulated period. A request to this effect has to be sent by email or fax more than ten days before the commencement date of the seminar. After receiving this request, we will issue a credit for the amount paid with a deduction of administration fees of $150. This credit note will be transferred to a future MentorHealth event, and a credit note will be issued towards this. You are allowed to make substitutions at any time till the start of the event. The substituting person should be present well in time for the event with proper written communication and company identity. If registering on the date of the seminar, please make sure you pay for the event using your credit card or check just before the start of the event. To such attendees, we may not be able to give the conference materials on the spot. In such an event; we will send the same after the conclusion of the seminar. No-shows will not be reimbursed. If MentorHealth cancels an event, we will not be reimbursing any airfare, accommodation, other costs or losses that the registrants may have incurred. MentorHealth reserves the right to change topics and speakers without notice.

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