 |
Due to the overwhelmingly positive
response to the May 15th Investigator Initiated Studies
for the Study Coordinator program, HRPO has closed
registration. However, presentations and materials
for the session are available below. |
Course Information
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Cost: |
There is no cost. |
|
CEU: |
Continuing Education Units (CEU)
will be awarded for this workshop. |
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Date: |
Friday, May 15, 2009 |
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Time: |
12:00 pm to 4:00 pm |
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Location: |
Farrell Teaching and Learning Center, Holden Auditorium |
Course Outline
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HOW TO WRITE A PROTOCOL OUTLINE
Evan Kharasch, MD, PhD
Objectives: To understand elements of a protocol.
To become familiar with the NIH protocol model and what is
entailed in each section. To identify important elements of a
protocol and the importance of each.
Slide Presentation:
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How to Write a Protocol Outline
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STUDY PROTOCOL
Craig
Coopersmith, MD
Objectives:
To understand elements of
a grant and why this is different than a protocol.
Slide Presentation:
- Study Protocol
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PROTOCOL ISSUES THAT WARRATN SPECIAL ATTENTION
Sarah
Fowler-Dixon, PhD
Objectives:
To identify what the regulations
allow with regards to consent. To identify which type of consent
is best for various types of studies. To understand when HIPAA,
conflicts of interest and re-consent apply to a study’s consent
process.
To delineate criteria in determining what type of data and
safety monitoring is best for a study. To understand what
information is necessary in developing a data monitoring plan
for a study.
To know the criteria used in determining if an investigational
drug or device exists. To understand the requirements of IND or
IDE holders. To know when one is the IND or IDE holder. To
understand FDA processes regarding INDs and IDEs.
Slide Presentations:
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Investigator Initiated Studies for the Study Coordinator
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Some Protocol Issues that Warrant Special Attention
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AFTER THE IRB APPROVAL
Sandy Dolin
and Michelle Jenkerson
Objectives:
Objectives: To become
familiar with some common errors and to be able to identify ways
to avoid or correct those errors so that they do not become
compliance issues.
To learn what source documents and standard operating procedures
are and understand their importance. To understand how these can
work together. To identify how source documents can be used as
standard operating procedures.
To know how to prepare for an audit. To understand the
difference between an internal and external audit. To identify
the steps necessary to prepare for an audit and know who to call
for assistance. To understand how source documents, standard
operating procedures, and documentation can keep one ready for
an internal or external audit.
Slide Presentations:
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Case Studies in Writing Protocols
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Now...What Do I Do With All This Paper
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Course Materials
Course Registration
Registration Closed
For more information please contact Mary Louise Seiff at
seiffm@wusm.wustl.edu.
Developed by:
Necessary Elements Steering and Oversight Committees
Initiated through cooperative efforts by:
Center for Applied Research Sciences (CARS)
Human Research Protection Office (HRPO)
Office of the Vice Chancellor for Research
and
Siteman Cancer Center
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