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Clinical Science Courses

Course Dates and Locations

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.

   

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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Course Fees

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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Overview

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

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,
ICH guidelines,
Regulatory issues (IND/NDA),
Case Report Form Design,
Source Documentation and Administration,
FDA Inspection Preparedness,
Clinical Pharmacology and Adverse Event Reporting,
Development of a Research Program and Budget, and
Ethical Issues in Clinical Trials.

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)
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)
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

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,
Radiology,
Anatomy and Physiology,
Cell Biology,
Genetics,
Clinical Laboratory Analysis,
Epidemiology, and
Research Statistics.

Session Descriptions

Anatomy and Physiology - Overview of selected Body Systems and Organs and how they function. (195 minute module)
Analysis of Laboratory Values - A review of basic laboratory values and their importance in the disease process. (225 minute module)
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)
Genetics and Pharmacogenetics - A review of the development and science supporting these interventions. (105 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. (195 minute module)

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Selected Faculty Overview

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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Online Registration Form (Credit Card)

Click HERE to register online!

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Course Application

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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