Monitoring
Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors
June 13 and 14, 2013
Renaissance Vancouver Harbourside Hotel
1133 West Hastings Street
Vancouver BC, V6E 3T3
Hotel phone: 604-689-9211
Reservations: 800-905-8582
SoCRA’s hotel room rate of $175 S/D CAD (plus applicable taxes) is available until May 21, 2013 or until the SoCRA room block is filled.
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| October 10 and 11, 2013 Sheraton Philadelphia Downtown Hotel
201 North 17th Street
Philadelphia, PA 19103
Hotel Phone: +1 (215) 448-2000
For Hotel Reservations, please contact the hotel or call (800) 627-8178. Please mention SoCRA to receive the hotel room rate of $195 S/D USD (plus applicable taxes), available until Sept. 9, 2013 or until the SoCRA room block is filled.
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Registration Fees:
- Member Fee- $610
- Non-Member Fee*- $685
* Non-Member Fees include a (non-refundable) one-year membership in SoCRA
Continuing Education Credit Hours:
SoCRA designates this educational activity for a maximum of 15 Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity for a maximum of 15 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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: 205-3-A-09
SoCRA Course Series: 200
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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 Harmonisation (ICH) guidelines as well as practical procedures and site / sponsor/ CRO relationships.
Learning Objectives: Upon completion of this (full) course 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 and financial disclosure
- Discuss regulatory requirements and ethical considerations involved in the informed consent process as well as the informed consent document
- 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
- 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
- Discuss mechanisms to implement and assure the quality of the processes and deliverables involved in clinical research
- 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
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Click HERE to Register Online* Note: If you experience difficulties, please use the PDF form.
Click Here to view/print the Course Application in Adobe PDF format.*
*SoCRA REGISTRATION POLICIES/INFORMATION:
- Non member fees include a one year membership in SoCRA.
- Membership fees are processed immediately and are not refundable.
Fees are in U.S. dollars.
- Please make checks payable to “SoCRA”
- Checks must be drawn on a U.S. bank or marked “Pay in U.S. Funds”.
- Written cancellation requests received by SoCRA at least 10 business days prior to start of course may receive a $430 refund.
- We regret that refunds cannot be issued for cancellations on or after 10 business days prior to start of course.
- Taping (audio or video) is prohibited unless SoCRA’s written permission has been acquired.
- ADA - This program is accessible to persons with disabilities. Please list any special needs in the area indicated in the registration form.
- If for any reason this conference cannot be held, SoCRA is not responsible for costs incurred by attendees, such as airfares, or hotel or other reservations.
- SoCRA is an educational non-profit membership organization (corporation) - Federal Tax ID #61 1208981.
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Click Here to view the Course Agenda in Adobe PDF format.
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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.
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