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CME/CE

Transforming a Clinician Into an Investigator: What Does It Take?

  • Authors: Leonard Sacks, MD; Robert L. Coleman, MD; Kenneth Getz, MBA; Frederick P. Ognibene, MD
  • CME/CE Released: 11/15/2011
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 11/15/2012
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Target Audience and Goal Statement

This activity is intended for clinicians who are interested in learning about clinical trials.

The goal of this activity is to help educate clinicians about clinical trials, particularly the responsibilities of clinical investigators.

Upon completion of this activity, participants will be able to:

  1. Summarize the major responsibilities of the clinical trial investigator in the United States
  2. Outline the challenges facing clinical trial investigators
  3. Identify strategies for overcoming barriers to participating as clinical investigators


Disclosures

As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


Authors

  • Leonard Sacks, MD

    Acting Director, Office of Critical Path Programs, US Food and Drug Administration, Silver Spring, Maryland

    Disclosures

    Disclosure: Leonard Sacks, MD, has disclosed no relevant financial relationships.

    Dr. Sacks does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the US Food and Drug Administration (FDA) for use in the United States.

    Dr. Sacks does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

  • Robert L. Coleman, MD

    Professor of Gynecologic Oncology, Vice Chair of Clinical Research, University of Texas, MD Anderson Cancer Center, Houston, Texas

    Disclosures

    Disclosure: Robert L. Coleman, MD, has disclosed the following relevant financial relationships:
    Served as an advisor or consultant for: BiPar Sciences; sanofi-aventis; Endocyte; Nektar Therapeutics; GlaxoSmithKline; AstraZeneca Pharmaceuticals LP; Morphotek, Inc.; Genentech, Inc.; Roche; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Merck & Co., Inc.; Boehringer Ingelheim Pharmaceuticals, Inc.
    Received grants for clinical research from: Merck & Co., Inc.; Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals, Inc.; Abraxis Oncology; Regeneron Pharmaceuticals, Inc.; sanofi-aventis; Novartis Pharmaceuticals Corporation; Genentech, Inc.

    Dr. Coleman does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

    Dr. Coleman does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

  • Kenneth Getz, MBA

    Senior Research Fellow, Tufts Center for the Study of Drug Development; Founder and Chairman, Center for Information and Study on Clinical Research Participation; Founder and Owner, CenterWatch, Boston, Massachusetts

    Disclosures

    Disclosure: Kenneth Getz, MBA, has disclosed no relevant financial relationships.

    Mr. Getz does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

    Mr. Getz does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

  • Frederick P. Ognibene, MD

    Deputy Director, Educational Affairs and Strategic Partnerships, National Institutes of Health Clinical Center, Bethesda, Maryland

    Disclosures

    Disclosure: Frederick P. Ognibene, MD, has disclosed no relevant financial relationships.

    Dr. Ognibene does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

    Dr. Ognibene does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

  • Sarah Williams, PhD

    Scientific Director, Medscape, LLC

    Disclosures

    Disclosure: Sarah Williams, PhD, has disclosed no relevant financial relationships.

CME Reviewer

  • Nafeez Zawahir, MD

    CME Clinical Director, Medscape, LLC

    Disclosures

    Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

Nurse Planner

  • Laurie E. Scudder, DNP, NP

    Nurse Planner, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC

    Disclosures

    Disclosure: Laurie E. Scudder, DNP, NP, has disclosed no relevant financial relationships.


Accreditation Statements

    For Physicians

  • Medscape, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

    Medscape, LLC designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Medscape, LLC staff have disclosed that they have no relevant financial relationships.

    Contact This Provider

    For Nurses

  • Medscape, LLC is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

    Awarded 0.75 contact hour(s) of continuing nursing education for RNs and APNs; none of these credits is in the area of pharmacology.

    Accreditation of this program does not imply endorsement by either Medscape, LLC or ANCC.

    Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]


Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 70% on the post-test.

Follow these steps to earn CME/CE credit*:

  1. Read the target audience, learning objectives, and author disclosures.
  2. Study the educational content online or printed out.
  3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. Medscape Education encourages you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage.

*The credit that you receive is based on your user profile.

From FDA and Medscape Education
CME/CE

Transforming a Clinician Into an Investigator: What Does It Take?

Authors: Leonard Sacks, MD; Robert L. Coleman, MD; Kenneth Getz, MBA; Frederick P. Ognibene, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME/CE Released: 11/15/2011

Valid for credit through: 11/15/2012

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Editor's Note:
Clinical trials are essential to the development of evidence-based medicine, and the role of clinical investigator represents a unique opportunity to participate in this vital process. Medscape Education has developed this CME/CE activity to help clarify the responsibilities of clinical investigators and to address some of the challenges that investigators face today. Experts from the US Food and Drug Administration (FDA), the National Institutes of Health, MD Anderson Cancer Center, and CenterWatch participated in this panel discussion, which was taped on September 20, 2011, at the FDA headquarters. The panel discussion was moderated by Dr. Leonard Sacks, Acting Director of the Office of Critical Path Programs at the FDA. Medscape Education is pleased to partner with these experts to bring this important program to its members.

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