Standard Operating Procedures (SOPs) Development and Implementation

Dates, Location, Contact Information and Fees New Canada Travel Passport Requirement (PDF) Pending Passport Applications Workshop Description Learning Objectives Workshop Agenda Online Registration Form (Credit Card) Workshop Registration Form (PDF)

Dates, Location, Contact Information, Fees, and SoCRA Program Chairpersons

July 24 and 25, 2008 Radisson Hotel Boston 200 Stuart Street Boston, MA 02116 U.S.A. Phone: +1 617 482 1800 or + 1 888 201 1718 Fax: +1 617 451 2750 SoCRA’s Hotel Room Rate of $159 (plus applicable taxes) is available through July 2, 2008 or until the SoCRA room block is filled.

Statement for Continuing Education Credit Hours
SoCRA designates this educational activity for a maximum of 11.75 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: 800

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Workshop Description

Standard Operating Procedures (SOPs) can be an effective tool to assist in the conduct of high quality clinical trials. This 2-day workshop will introduce, explain, and discuss fundamental concepts and current issues in the development and implementation of effective SOPs for the investigational site. Participants will discuss basic principles and current challenges regarding development, writing, and implementation of SOPs. This workshop will also address the implication of the Canadian Regulations regarding systems and procedures related to quality processes to be developed at the clinical site. Participants will develop and discuss an example of an effective standard operating procedure. The instructors will share their experiences and the knowledge gained from years of working in various settings such as; global pharmaceutical industry, CROs, small and large clinical research sites, and regulatory agencies. This workshop consists of lectures, discussions, and interactive group exercises.

Program Chairperson: Donna Headlee, RN, BSN, CCRP

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Learning Objectives

Upon completion of the workshop, the attendee should be able to:

• Define and discuss standard operating procedures.
• Describe the benefits of an effective SOP program.
• Discuss the Canadian Regulations regarding systems and procedures of quality processes to be developed and implemented at the clinical site.
• Describe how to develop procedures related to workflow.
• Describe the recommended format and content of an effective written procedure.
• Discuss effective writing strategies.
• Describe factors that assist in the approval and implementation of standard operating procedures.
• Develop an effective SOP.
• Demonstrate an ability to present and discuss participant’s work product.
• Identify policies and procedures appropriate to clinical research.
• Discuss effective educational and training programs.
• Discuss how to design policies and procedures to fit the specific needs of an institution.
• Discuss examples of successful implementations.
• Describe mechanisms to avoid unsuccessful implementations.

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Workshop Agenda

The Workshop Agenda 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 Workshop Agenda in Adobe PDF format.

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Online Registration Form (Credit Card)

Click HERE to register online!

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Workshop Registration Form

The Workshop Registration Form 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 Workshop Registration Form in Adobe PDF format.

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