Standard Operating
Procedures (SOPs) Development and Implementation
June 6 and 7, 2013
Delta Chelsea Hotel
33 Gerrard Street West
Toronto, ON M5G 1Z4 CANADA
Hotel Phone: +1 (416) 595-1975
Reservations: +1 (800) 243-5732
SoCRA Hotel Room Rate of $139 S/D CAD (plus applicable taxes) is available until May 6, 2013 or until the SoCRA room block is filled.
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Registration Fees:
- Member Fee: $585
- Non-member: $660
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 13 Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity for a maximum of 13 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: 800
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Program Chairperson: Donna Headlee, RN, BSN, CCRP
Goal: 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.
Objective: The goal will be accomplished through lectures, discussions and activities. This workshop will be facilitated by clinical research professionals with experience in clinical research as well as experience and expertise in the development and implementation of SOPs. Information will be presented and discussed on what SOPs are, why we need such documents, how to develop SOPs, how to prioritize the implementation of the various SOPs required at the investigational site, and how to implement and use SOPs. Discussion will consider issues related to the use of, and impact of SOPs. Additionally, discussion will continue regarding the importance of strategies for addressing the approval process, development of a training program, and tracking of training and implementation results.
Learning Objectives:
- 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.
- Discuss effective writing strategies.
- Describe the recommended format and content of an effective written procedure.
- Describe how to develop procedures related to workflow.
- Identify policies and procedures appropriate to clinical research.
- Develop a procedure related to the development of a standard operating procedure process.
- Demonstrate an ability to present and discuss participants’ work product.
- Describe factors that assist in the approval and implementation of standard operating procedures.
- Develop an effective standard operating procedure process.
- Demonstrate an ability to present and discuss participants’ work product.
- 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 key issues related to the development of standard operating procedures for clinical research
- Describe mechanisms to avoid unsuccessful implementations.
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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 Workshop Registration Form 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 $410 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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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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DONNA HEADLEE, RN, BSN, CCRP
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Donna Headlee, RN, BSN, CCRP, has a Bachelors of Science in Nursing and a Master’s Certificate in Regulatory Compliance. She has been with the FDA in the Center of Devices and Radiological Health since July 2004. She was with the Office of Compliance, Bioresearch Monitoring, Special Investigations Branch for approximately 5 ½ years. One of her responsibilities was coordinating and maintaining SOPs for the Division of Bioresearch Monitoring. Recently she transferred to the Office of Device Evaluation in the Program Support Office on the PreMarket Approval Staff. Prior to joining the FDA, she was a research nurse with National Cancer Institute. She was with the NCI for approximately 14 years and was responsible for coordinating Phase I oncology clinical trials. While with the NCI she initiated and coordinated the development of Standard Operating Procedures for the Division of Cancer Research. She had the honor of serving as president of SoCRA and currently serves as certification committee chair for SoCRA . |
JOANNE GOLDBERG, MSc, pht, CCRP
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Joanne Goldberg, MSc, pht, CCRP, is the Assistant Director of the Canadian Institutes of Health Research’s Institute of Aging in Montreal, Canada. She holds a Master of Science degree in Biomedical Sciences from the University of Montréal as well as a Bachelor of Sciences degree in Physical Therapy from the same institution. She has been involved in clinical research for the past 18 years and has held many positions including Associate Director of Scientific Affairs, Director of Training, Director for Clinical Site Network Management, Director of Quality Management Systems, Senior Project Manager, Senior Study Coordinator, as well as Investigator. Her expertise is primarily in the development and implementation of international partnerships for health research as well as quality management systems, training in Good Clinical Practices, study methodology, and writing and implementing standard operating procedures. She is responsible for the French language translation and administration of the Society of Clinical Research Associates’ (SoCRA) certification examination and Preparatory Course. Joanne is a member of the SoCRA Certification Committee and is a Past President of the Society.
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