Monitoring

Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors

Dates, Locations, Contact Information, and Fees
Goal
Objective
Credit Hours
Learning Objectives
Course Faculty
Workshop Agenda
Online Registration Form (Credit Card)
Workshop Registration Form

Dates, Locations, Contact Information, and Fees

April 24 and 25, 2008

Crowne Plaza Hotel Denver
1450 Glenarm Place
Denver, CO 80202-5024

Phone: 303.573.1450
Fax: 303.572.1113

SoCRA Hotel Rate: $159 (in U.S. funds) is available until four weeks prior to the course or until the SoCRA room block is filled.

October 16 and 17, 2008

Radisson Plaza/Warwick
1701 Locust Street
Philadelphia, PA 19103

Phone: 215.735.6000
Fax: 215.789.6105

SoCRA Hotel Rate: $179 (in U.S. funds) is available until four weeks prior to the course or until the SoCRA room block is filled.

Goal

The Society of Clinical Research Associates (SoCRA) recognizes the continuing need for education for Clinical Research Professionals. The purpose of this workshop is to assist Research Site Coordinators, Quality Assurance Auditors, and Monitors, in improving their skills and their understanding of the roles and responsibilities of the Clinical Research Associate/Monitor. Although designed with all research professionals in mind, this program is ideal for Research Study Coordinators who want to improve the understanding of their responsibilities and interactions with their Clinical Research Monitors, and for Monitors/Auditors with 0-5 years monitoring experience who want to increase their knowledge and understanding of monitoring responsibilities.

Objective

The goal will be accomplished through lecture and practical application facilitated by clinical research professionals with a combined industry experience of more than 20 years. Information will be presented and discussed regarding monitoring clinical trials according to FDA Regulations and International Conference on Harmonization (ICH) guidelines as well as practical procedures and site /sponsor/CRO relationships.

Credit Hours

Continuing Education Credit Hours
SoCRA designates this educational activity for a maximum of 15 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: This continuing nursing education activity was approved by the PA State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. ANCC/PSNA Provider Reference Number: 068-1-A-07

SoCRA Course Series: 200

Learning Objectives

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

Discuss the basic principles of Good Clinical Practice; International Conference on Harmonisation GCP guidance; Investigator’s responsibilities; Sponsor’s responsibilities; Monitor’s responsibilities; record retention; and basic requirements for conducting studies in Canada.
Describe the investigator recruitment process, identify key selection criteria, and discuss the conduct of a site selection visit.
Within the historical perspective of the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, discuss the objectives of regulations pertaining to Institutional Review Boards, informed consent, and financial disclosure.
Describe the activities involved in study initiation including budget and contract negotiation; planning and conducting investigator meetings; investigator selection; the conduct of study initiation visits; and preparing the site for study participation.
Assess the collection and evaluation of research data for completeness, compliance, and accuracy through periodic monitoring visits; discuss reporting and follow-up correspondence.
Explain the activities involved in Monitoring a study.
Compare and contrast the auditing and monitoring functions; describe the objectives of auditing; describe FDA inspections and how to prepare for them; review FDA warning letters.
Describe the essential elements of planning and preparing for and conducting a site closeout visit; site follow-up; and final documents for closure.
Describe site management techniques to manage expectations, facilitate site interactions, and to improve subject recruitment and study conduct.
Discuss additional investigator responsibilities and monitoring of investigator-initiated studies.

CERTIFICATION - The examination for Certified Clinical Research Professionals will be held the day following the conclusion of this workshop. Click HERE to go to the Certification page for an application.

Course Faculty

Jacqueline Busheikin, RN, CCRP
Jacqueline Busheikin, RN, CCRP, is President of JANA Research Corporation, an independent clinical research consulting/monitoring organization established in 2001. She is a registered nurse and had been working in the field of clinical trials since 1989 as a study coordinator - specializing in Mental health, mainly schizophrenia, at the University of Calgary/Foothills Medical Centre. She was the first research coordinator at the Foothills Medical Centre and was responsible for establishing all standard operating procedures and for organizing the functioning of the unit. Ms. Busheikin has also presented numerous training and educational programs for site coordinators and clinical research monitors.

George H. D'Addamio, Ph. D.
George H. D'Addamio, Ph. D. is President of PharmConsult, Inc., a consulting firm in Atlanta, GA that specializes in the preparation of clinical development documents. During 8 years at SmithKline & French Laboratories (now Glaxo SmithKline), Dr. D'Addamio was responsible for preparing protocols, case report forms, integrated study reports, and regulatory submissions in Clinical R & D and Medical Affairs. As Scientific Manager, Clinical R & D, he was responsible for coordinating clinical research programs in Canada and Latin America. In Medical Affairs, he managed operational groups responsible for medical writing, clinical monitoring, and CRF safety reviews and auditing. After leaving SmithKline & French, Dr. D'Addamio worked with a CRO for 1.5 years before forming PharmConsult. His consulting experience includes project management and statistical services in addition to medical writing in various therapeutic areas for both domestic and foreign pharmaceutical companies.