February 2024 SOCRA Source Journal - Journal - Page 99
SOCRA Quality Management Conference
2024 COURSE DATES COMING SOON
Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical
Research Professionals responsible for the activities at the research site or institution. The purpose of this workshop is to
assist research professionals in understanding, developing and implementing quality management systems (QMS) in the
conduct of clinical trials. This conference provides attendees with new information, tools, and real life examples to help
participants navigate the components of quality management in clinical research - quality planning, quality control, quality
assurance, and quality improvement.
Objective: The goal will be accomplished through lecture and practical application facilitated by clinical research
professionals. Information will be presented and discussed regarding the development and implementation of quality
management systems in the conduct of clinical trials according to FDA Regulations and International Council on
Harmonisation (ICH) guidance.
Learning Objectives: Upon completion of this (full) course the attendee should be able to:
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Discuss the importance of quality management systems (QMS) in clinical research
Review the key steps and elements in Risk Management and Quality Systems
Discuss best practices in assessing and mitigating risk in clinical trial project management
Discuss risk assessments, monitoring plan creation, and monitor training
Discuss how to develop and implement a Quality Assurance (QA) Program for Investigator-Initiated Trials (IITs)
Review the planning and implementation of real life examples of quality initiatives
Review the essentials of conducting an audit/inspection ready study
Review best strategies on audit/inspection close out processes including CAPA development and
implementation
Discuss the management of serious breaches and non-compliance
Outline the impact of system non-compliance, sanctions, and fraud
Outline the top QA and QC trends to elucidate ideal training and educational needs
SOCRA designates this educational activity for a maximum of 12.0 Continuing Education Credits for SOCRA CE and
Nurse CNE.
SOCRA designates this live activity for a maximum of 12.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only
the credit commensurate with the extent of their participation in the activity.
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 accredited as a provider of continuing nursing education by the American
Nurses Credentialing Center's Commission on Accreditation.
SOCRA Course Series: 120
SOCRA SOURCE © November 2023
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