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 […]