(Other authors and contributors listed below in Summary of Faculty Disclosures)

ACCREDITATION

The University of Miami Leonard M. Miller School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

These CME activities were planned and produced in accordance with the Accreditation Council for Continuing Medical Education Essential Areas, Elements and Policies.

The University of Miami Leonard M. Miller School of Medicine is approved by the American Psychological Association to sponsor continuing education for psychologists. The University of Miami Leonard M. Miller School of Medicine maintains responsibility for this program and its content.

TARGET AUDIENCE

All physicians and specialties involved in research including investigators, nurses, students, staff and administrators.

CITI Basic Course in the Protection of Human Research Subjects

CREDIT DESIGNATION PERIOD – July 9, 2010 – June 30, 2013

DATE OF ORIGINAL RELEASE – June 2001

DATE OF MOST RECENT UPDATE – June 2010

Continuing Education Certificate Fee

Physician (AMA PRA Category 1 Credit™)

3 Credits (6 modules) - $60

6 Credits (12 modules) - $80

Psychologist (CE Credit)

6 Credits (12 modules) - $80

All other participants

Certificate of Completion (12 modules) - $80

To receive credit participants must:

· Complete a minimum number of modules, excluding the introduction as follows:

o 6 modules for 3 credits

o 12 modules for 6 credits

· Complete the post-tests with an aggregate score of 70%

· Complete the online evaluation, registration and payment process (see link below)

CREDIT DESIGNATION

The University of Miami Leonard M. Miller School of Medicine designates this educational activity for a maximum of 6 AMA PRA Category 1 Creditsä. Physicians should only claim credit commensurate with the extent of their participation in the activity.

OBJECTIVES

At the conclusion of this activity participants are able to:

· Incorporate the federal regulations and policies, which protect human subjects into the research environment.

· Improve human subjects research study design through greater attention to potential risks and harms associated with human subject participation in research.

· Evaluate the Belmont Report as the foundation of US policies toward human subjects research.

· Identify how risks and potential harms associated with participation in social and behavioral human subjects research are less predictable with respect to occurrence, effect and long term outcome.

CITI Continuing Education (Refresher) Course

CREDIT DESIGNATION PERIOD – July 9, 2010 – June 30, 2013

DATE OF ORIGINAL RELEASE – June 2001

DATE OF MOST RECENT UPDATE – June 2010

Continuing Education Certificate Fee

Physician (AMA PRA Category 1 Credit™)

2 Credits (12 modules) - $40

Psychologist (CE Credit)

2 Credits (12 modules) - $40

All other participants

Certificate of Completion (12 modules) - $40

To receive credit participants must:

· Complete a minimum of 12 modules, excluding the introduction

· Complete the post-tests with an aggregate score of 70%

· Complete the online evaluation, registration and payment process (see link below)

CREDIT DESIGNATION

The University of Miami Leonard M. Miller School of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 Creditsä. Physicians should only claim credit commensurate with the extent of their participation in the activity.

OBJECTIVES

At the conclusion of this activity participants are able to:

· Incorporate the federal regulations and policies, which protect human subjects into the research environment.

· Improve human subjects research study design through greater attention to potential risks and harms associated with human subject participation in research.

· Evaluate the Belmont Report as the foundation of US policies toward human subjects research.

· Identify how risks and potential harms associated with participation in social and behavioral human subjects research are less predictable with respect to occurrence, effect and long term outcome.

CITI Good Clinical Practices Course

CREDIT DESIGNATION PERIOD – July 9, 2010 – June 30, 2013

DATE OF ORIGINAL RELEASE – April 2007

DATE OF MOST RECENT UPDATE – June 2010

Continuing Education Certificate Fee

Physician (AMA PRA Category 1 Credit™)

4 Credits (8 modules) - $60

All other participants

Certificate of Completion (8 modules) - $60

To receive credit participants must:

· Complete a minimum of 8 modules, excluding the introduction

· Complete the post-tests with an aggregate score of 70%

· Complete the online evaluation, registration and payment process (see link below)

CREDIT DESIGNATION

The University of Miami Leonard M. Miller School of Medicine designates this educational activity for a maximum of 4 AMA PRA Category 1 Creditsä. Physicians should only claim credit commensurate with the extent of their participation in the activity.

OBJECTIVES

At the conclusion of this activity participants are able to:

· Incorporate the federal regulations for drug development into clinical research.

· Determine the role of the International Conference on Harmonisation as it relates to clinical research.

· Develop studies that are aligned with the international standards for clinical research.

· Identify clinical researcher responsibilities.

CITI Health Information Privacy and Security Course

CREDIT DESIGNATION PERIOD: July 23, 2010 – June 30, 2013

DATE OF ORIGINAL RELEASE – July 2010

DATE OF MOST RECENT UPDATE – May 2010

Continuing Education Certificate Fee

Physician (AMA PRA Category 1 Credit™)

1.5 Credits (5 modules) - $10

Psychologist (CE Credit)

1.5 Credits (5 modules) - $10

All other participants

Certificate of Completion (5 modules) - $10

To receive credit participants must:

· Complete a minimum of 5 modules as follows:

1. Privacy Rules: Introduction to Federal and State Requirements

2. Security Rules: Basics of Being Secure, Part 1

3. Security Rules: Basics of Being Secure, Part 2

4. Security Rules: Introduction to Federal and State Requirements

AND

5. ONE of the following modules:

o Privacy Rules: Clinicians

o Privacy Rules: Researchers

o Privacy Rules: Students and Instructors

o Privacy Rules: Fundraisers

o Privacy Rules: Marketers

· Complete the post-tests with an aggregate score of 70%

· Complete the online evaluation, registration and payment process (see link below)

CREDIT DESIGNATION

The University of Miami Leonard M. Miller School of Medicine designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Creditsä. Physicians should only claim credit commensurate with the extent of their participation in the activity.

OBJECTIVES

At the conclusion of this activity participants are able to:

· Use protected identifiable health information only for legitimate work purposes

· Utilize minimum necessary information for intended work purposes

· Employ additional protections for designated sensitive types of health information

· Provide appropriate, timely and accurate information to designated organizational representatives about privacy problems that are observed or suspected

· Provide appropriate, timely and accurate information to patients about their privacy rights

· Incorporate information security practices into the context of daily professional activities (viz., when accessing, storing or disclosing identifiable health information in the systems used in their practice settings), in order to secure patients’ privacy rights.

SUMMARY OF FACULTY DISCLOSURE

The following authors and planners have indicated that they have no relevant financial relationships with commercial interests:

Tracy Arwood, MS

Elizabeth Bankert, MA

Paul Braunschweiger, PhD

Anita Cava, JD

Gary L. Chadwick, PharmD, MPH

Maristela Cho, MA

Jeffrey M. Cohen, PhD, CIP

Jeffrey Cooper, MD, MMM

Reid Cushman, PhD

Deborah Dickstein, MPH

Norma Epley, MS

Janelle Erickson, MPH

E. Dawn Fitzgibbons, PhD

Robin Fiore, PhD

David Forster, JD, MA, CIP

Barbara Davis Goldman, PhD

Kenneth Goodman, PhD

Bruce Gordon, MD

Alison Handler, BSN, CCRC

Karen Hansen

Lorna Hicks, MS, CIP

Stephan Kiefer, PhD, CIP

Susan Kortensky, MPH

Wenjin Li, MD

Erica Lim, MSW

Patricia Masters, MSN

Judy Matuk, MS

Helen McGough, MA

David Miller, PhD

Gordon Olacsi, CIP

Diane Paul, MS, RN

Sangeeta Panicker, PhD

Charles E. Pietri, BA

Joan Porter, DPA, MPH

Ernest Prentice, PhD

Susan L. Rose, PhD

Deborah Rosenbaum, CRCC, CCRA, CCRT

Lawrence B. Rosenfeld, PhD

Cheryl Savini, CIP

Ada Sue Selwitz, MA

Mary Simmerling, MA

Karen Smith, PhD

Celia Walker, MA

Barbara Young, PhD