Goal The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination. This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice including the ICH Guidelines and FDA Regulations that govern clinical research practice. Objective The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records. Learning Objectives Upon completion of the workshop, the attendee should be able to: Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice Discuss the basic components of compliance - Law, regulation, guidance, policy and procedure Explain the drug/biologic development process Describe the device development process Outline concepts for Good Clinical Practice (GCP) Explain the elements of informed consent Describe the membership and reporting requirements of IRBs […]

This virtual symposium is a distinct opportunity for Sponsor-Investigators and key research staff to receive targeted training directly from FDA, NIH, and research industry representatives. It will provide insight into the unique dual-role of sponsor-investigators with in-depth coverage of the applicable FDA regulations, guidelines, and best practices. Attendees will take away tools for designing and managing quality research studies that will produce accurate and complete data submissions. The two (2) full-day schedule allows for less disruption to clinical practice and continuing education credits (CME/CNE/SOCRA CE) apply. Please note, this workshop is intended to be interactive. Video attendance is strongly encouraged. Once you register, you will be able to install and test the appropriate software to ensure your audio and video will work properly during the program. Please be sure to give yourself time to address any technical issues that might arise. Please contact us with any questions or concerns at education@socra.org. Continuing Education Credit Hours: SOCRA designates this educational activity for a maximum of 11.75 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 11.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of […]

This interactive virtual workshop will be facilitated by clinical research professionals with a wealth of industry expertise. The purpose of this workshop is to assist research professionals in improving their skills and their understanding of the responsibilities of conducting clinical research in the pediatric population. This conference provides attendees with new information, management tools, and real life examples, to help participants navigate the evolving landscape of pediatric research. Continuing Education Credit Hours SOCRA designates this educational activity for a maximum of 6.5 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 6.5 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 accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. SOCRA Course Series: 850

Goal This introduction to clinical research project management workshop incorporates a broad range of skill sets in order to plan, administer, track, evaluate and report on activities involved clinical research process. The goal of this interactive workshop is to introduce, affirm, and enhance the participant’s understanding of project management. Objective Through discussion, presentation, and interaction, this virtual program will broaden the participants’ knowledge of the project management art and science. Please contact us with any questions or concerns at education@socra.org. Learning Objectives Upon completion of the workshop, the attendee should be able to: Describe  skills and responsibilities to move from a clinical research coordinator or other research roles to learn about the responsibilities of a Project Manager. Define key terms and concepts associated with Project Management. Describe project management processes following PMI (Project Management Institute) guidelines (initiation, planning, execution, monitoring, controlling, and closing). Discuss the processes and procedures that are necessary to develop an infrastructure that will support the various tasks associated with Project Management in Clinical Research. Describe Project Management constraints including Scope, Time, Budget, and Performance. Learn about effective strategies in Virtual Project Management and Decentralized Clinical Trials. Discuss basic principles of Risk Management, Risk Avoidance and Risk Mitigation. Learn […]