CITI GOOD CLINICAL PRACTICE COURSE

CREDIT REQUEST FORM

 

To receive credit, mail this form to the University of Miami, Division of Continuing Medical Education at the address listed below (or fax with credit card payment).

 

 Credit is available for the period of April 12, 2007 to May 31, 2010.

 

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

 

CREDIT DESIGNATION:  The University of Miami Leonard M. Miller School of Medicine designates this educational activity for a maximum of 4.0 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

 

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For verification purposes, please provide USERNAME:       

 

Complete below (Place a check mark in the appropriate box)

  Physician AMA PRA Category 1 Credit™ CME

CERTIFICATE OF COMPLETION

  Nurses/Allied Health Professionals

 

CERTIFY COURSE COMPLETION

  I certify that I have completed the CITI Good Clinical Practice Course as designed.

Indicate the total amount of time you spent completing this educational activity:      

A maximum of 4 credits will be awarded for completion of all 8 modules.

 

Signature:                                                                                                   Date:      

 

 

TUITION:   $60  - Please note:  checks are not accepted.

Please charge my registration fee in the amount of $       to my:     Visa®                  MasterCard®      Discover®

Card Number                                                                                     CCV Number (3-digit code on back of card):      

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Authorized Signature     _____________________________________

 


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Please answer the following questions using the rating scale:   1 = Strongly Disagree  ..........4 = Strongly Agree      

(Do not evaluate any objective listed below that did not apply to the modules you completed)

The program met the following objectives: Upon completion of this online course participant should be able to:

  • International Conference on Harmonization
    • Identify the basic requirements for compliance with ICH and relate how ICH fits with U.S. federal regulations regarding clinical research

 

4   3   2   1 

           

  • FDA Regulated Research and ICH
    • Explain the guideline that primarily affects investigators in the daily practice of clinical research is E6, "ICH Harmonized Tripartite Guideline: Guideline for Good Clinical Practice."

 

4   3   2   1 

           

  • Managing Investigational Agents According to GCP Requirements
    • Identify regulatory obligations of investigators conducting clinical trials of investigational agents

 

4   3   2   1 

           

  • Conducting Clinical Trials of Medical Devices
    • Define the responsibilities of investigators conducting clinical research involving medical devices

 

4   3   2   1 

           

  • Informed Consent: An Ongoing Process
    • Describe the requirements for complying with informed consent regulations

 

4   3   2   1 

           

  • Detection and Evaluation of Adverse Events
    • Identify the factors to consider in assessing the severity and casualty of AEs

 

4   3   2   1 

           

  • Reporting serious Adverse Events
    • Identify the criteria for reporting SAEs to regulatory agencies, sponsors, etc, and define “Serious” and “Unexpected” adverse events

 

4   3   2   1 

           

 

 

Participation in this activity has:

Yes

No

·   Increased my knowledge

 

 

·   Improved my competence (ability to perform)

 

 

·   Enhanced my performance (will practice regularly in my workplace)

 

 

·   Ensured that my patients will have improved outcomes (population health improvement)

 

 

 

 

I intend to make the following changes in my practice as a result of this learning activity:

 

 

 

 

 

 

 

 

 

 

 

University of Miami School of Medicine

Division of Continuing Medical Education

PO Box 016960 (D23-3),   Miami, FL   33101

Tel:  305-243-6716        Fax:  305-243-5613

Webpage:  http://cme.med.miami.edu