 | Clinical Science Courses
July 14-18, 2008
Radisson Chicago Hotel and Suites
160 East Huron Street
Chicago, IL 60611 U.S.A.
Phone: 312-787-2900
Fax: 312-787-5158
SoCRA’s Hotel Room Rate of $189 (plus applicable taxes) is available through June 20, 2008 or until the SoCRA room block is filled.
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November 3-7, 2008
Chaparral Suites Resort Scottsdale
5001 N. Scottsdale Road
Scottsdale, AZ 85250 USA
Phone: +1 800 528 1456 or 480 949 1414
Fax: +1 480 947 2675
SoCRA’s Hotel Room Rate of $149 (plus applicable taxes) is available through October 3, 2008 or until the SoCRA room block is filled.
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Full five day program - member - $1150 - non-member - $ 1,225
Module 1 - member - $750 - non-member - $ 825
Module 2 - member - $600 - non-member - $ 675
Non-member fee includes membership for one year
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The Society of Clinical Research Associates proudly announces their Two Module Clinical
Science Course for Clinical Research Professionals.
This course is designed to enhance the knowledge base required by clinical research
professionals. This course has been established in order to develop an internationally
accepted standard of knowledge and understanding of the research process and related
regulations, as well as medical and scientific areas related to clinical research.
The course contains two modules. The attendee may elect to attend one or both modules.
Statement for Continuing Education Credit Hours
SoCRA designates this educational activity for a maximum of 35 Continuing Education Credit Hours for SoCRA CE, Nurse CNE, and Physician Category 1 CME.
Accreditation Statements:
- CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
- CNE for Nurses: Society of Clinical Research Associates is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. ANCC/PSNA Provider Reference Number: 070-3-A-07
SoCRA Course Series: 100
Module 1 is the Regulatory / Procedural Module consisting of sessions pertaining to:
 | Issues Involved in Addressing the Development Process |
| Clinical Pharmacology and AE Reporting |
| Development and the Research Budget |
| Good Clinical Practices |
| ICH Guidelines |
| Informed Consent |
| Preparing for an FDA Audit |
| Regulatory Affairs and IRBs (IND/NDA) |
| Research Ethics |
| Source Documentation and Administration |
Module 2 is the Medical / Scientific Module consisting of sessions pertaining to:
| Ethical Issues in Clinical Trials |
| Anatomy and Physiology |
| Cell Biology |
| Genetics |
| Clinical Laboratory Analysis |
| Epidemiology |
| Research Statistics |
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Module 1 is a three day course. It offers 21 CE (Continuing Education) credit hours. Faculty includes
internationally-recognized faculty from Duke University, University of North
Carolina, University of Florida, and other guest lecturers.
Sessions
Module 1 is the Regulatory / Procedural Module consisting of sessions pertaining to:
| Issues Involved in Addressing the Development Process,
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| ICH guidelines,
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| Regulatory issues (IND/NDA),
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| Case Report Form Design,
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| Source Documentation and Administration,
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| FDA Inspection Preparedness,
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| Clinical Pharmacology and Adverse Event Reporting,
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| Development of a Research Program and Budget, and
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| Ethical Issues in Clinical Trials.
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Session Descriptions
| Clinical Pharmacology and AE Reporting
- Understanding the presentation and detection of adverse drug events, the
pharmacodynamic and pharmacokinetic mechanisms of reactions, methods of
causality assessment, safe medication practices in clinical research,
and the FDA’s Risk Management Program.
(225 minute module) |
| Development and the Research Budget - Review of
(drug, device, biologics) development program, including protocol
development, Case Report Form design, project and program management,
assessing costs and building budgets. How to develop budgets and strategies
for reducing costs (at the investigational site). (195 minute module)
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Drug Development Process - Review and
discussion regarding the definitions, regulations and processes from IND to
NDA. This session includes Regulatory Affairs and IRBs (IND/NDA) - Review of
federal regulations, IRB guidelines, written procedures, and record keeping
requirements for clinical trials management. (120 minute module)
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ICH Guidelines - Discussion about the
development and implementation of the International Committee on
Harmonization, the clinical research guidelines resulting from that
collaboration, and how the ICH Guidelines affect the clinical Researcher.
(105 minute module) |
| IRBs and the Informed Consent Process
- Discussion of regulations, generally accepted policies and procedures, and
audit practices associated with IRBs and the informed consent process. (105
minute module) |
| Preparing for an FDA Audit - Perspectives and regulations regarding
adherence to protocol, patient rights, informed consents, and regulatory issues related to
an FDA audit. (195 minute module) |
| Research Ethics - The importance of the informed consent and the
principles of medical research ethics are discussed as well as therapeutic misconceptions,
randomizations, and placebos. This session includes Regulatory Affairs and
IRBs (IND/NDA) - Review of federal regulations, IRB guidelines, written
procedures, and record keeping requirements for clinical trials management.
(195 minute module) |
| Source Documentation and Administration - Review of procedural and
management issues regarding utilization and disposition of source documents.
(120 minute module) |
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Module 2 is a two-and-one-half day course. It offers 17.25 CE (Continuing Education) credit hours. Faculty
includes internationally recognized faculty from Duke University, University of
North Carolina, University of Florida, and other guest lecturers.
Sessions
Module 2 is the Medical / Scientific Module consisting of sessions pertaining to:
| Ethical Issues in Clinical Trials,
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| Radiology, |
| Anatomy and Physiology,
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| Cell Biology,
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| Genetics, |
| Clinical Laboratory Analysis,
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| Epidemiology, and
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| Research Statistics.
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Session Descriptions
| Anatomy and Physiology - Overview of selected Body Systems and Organs
and how they function. (195 minute module)
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| Analysis of Laboratory Values - A review of basic laboratory values and
their importance in the disease process. (225 minute module)
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Cell Biology - Understanding cell structure, function, and
reproduction. (120 minute module) |
| Epidemiological and Statistical Issues - The study of the distribution and
determinants of health related events in certain populations. (195 minute module)
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Genetics and Pharmacogenetics - A review of the development and science
supporting these interventions. (105 minute module)
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| Research Ethics - The importance of the informed consent and the
principles of medical research ethics are discussed as well as therapeutic misconceptions,
randomizations, and placebos. (195 minute module)
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The Selected Faculty Overview is available in Adobe PDF format, which can be viewed using the
free-download of Adobe Acrobat Reader. (Click Here to Download this
FREE software.)
Click Here to view/print the
Selected Faculty Overview in Adobe PDF format.
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Click
HERE
to register online!
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The Course Application is available in Adobe PDF format, which can be viewed using the
free-download of Adobe Acrobat Reader. (Click Here to Download this
FREE software.)
Click Here to view/print the Course Application
in Adobe PDF format.
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