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DTSTART;VALUE=DATE:20261028
DTEND;VALUE=DATE:20261029
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SUMMARY:CCRP Prep and GCP Review Course 
DESCRIPTION:SOCRA Education · Live Virtual Course \nCCRP Certification Preparation and GCP Virtual Review Course\n\nDatesWednesday\, December 2 – Thursday\, December 3\, 2026\nTimeBegins 12:00 PM ET\nFormatLive Virtual\n\nRegister on SOCRA Elevate →\n\n \n\n\nMember Rate \n$295.00 \n\n\nNon-Member Rate \n$370.00 \n\n\n\n\nGoal\nThe purpose of this workshop is to assist the participant in preparing for the CCRP certification examination. \nThis 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. \n\n\nObjective\nThe 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. \n\n\n \n\nLearning Objectives\nUpon completion of the workshop\, the attendee should be able to: \n\nDiscuss the basic requirements necessary to meet the demands of a CRP in clinical practice\nDiscuss the basic components of compliance – Law\, regulation\, guidance\, policy and procedure\nExplain the drug/biologic development process\nDescribe the device development process\nOutline concepts for Good Clinical Practice (GCP)\nExplain the elements of informed consent\nDescribe the membership and reporting requirements of IRBs\nExplain rules relating to financial disclosure\nDiscuss the basics of study design\nExplain the rules and reporting requirements for adverse events and serious adverse events\nExplain study closure procedures and record retention guidelines\nOutline the reasons for monitoring\, audits and site visits\nExplain the Food and Drug Administration rules\, regulations\, and guidelines on research\nDiscuss the importance of investigational drug accountability\nDemonstrate and describe how to read clinical reports and records\nDiscuss Quality Assurance including\, Monitoring and Auditing\nExplain issues that would constitute clinical fraud\n\n\n\nThe purchase of this course is optional. It is not required to sit for or pass the CCRP certification exam. Purchasing and completing this course will not guarantee a passing score on the CCRP certification examination. \n\n \n\nMeet the Faculty\n\n\n \nLaura Holtz\, MS\, CCRP\nSenior Research Manager \nLaura Holtz is a Senior Quality Specialist at the Yale Cancer Center Clinical Trials Office and a past SOCRA President. She established SOCRA’s Indianapolis chapter and co-facilitates SOCRA’s CCRP and GCP Exam Prep course. \n\nRead full bio\nLaura R. Holtz\, MS\, PMP\, CCRP\, is a Senior Quality Specialist at Yale University\, Yale Cancer Center\, Clinical Trials Office. Previously\, she was a senior project manager at the Indiana University Center for Aging Research on federally-funded randomized control trials and demonstration programs to provide care collaboration for patients with dementia and their caregivers in multiple care settings. She also coordinated an annual statewide conference focused on palliative and end-of-life communication and research. She shares her expertise in regulations\, informed consent\, decision making capacity\, patient/caregiver interviewing\, ethics\, and research project management at numerous local and national conferences. Laura established the Indianapolis chapter of Society of Clinical Research Associates (SOCRA) and organizes education opportunities which provide pathways for staff to become Certified Clinical Research Professionals. She is a co-facilitator for the SOCRA Clinical Site Coordination/Management and Good Clinical Practice (GCP) workshop and the Certified Clinical Research Professional (CCRP) and GCP Exam Prep course. As the past SOCRA President\, she contributes to the organization’s strategic objectives to provide research education\, networking opportunities and professional credentialing for the research community. Laura has a Master of Science in Communications from Purdue University. \n\n\n\n \nKatrina A. Croghan\, MS\, CCRP\nProgram Director of Applied Clinical Research ProgramSt. Cloud State University \nKatrina Croghan is Program Director of the Applied Clinical Research Program at St. Cloud State University and Quality Management Coordinator at the Mayo Clinic Comprehensive Cancer Center. A CCRP since 2014\, she co-chairs the SOCRA Southeast MN Chapter and serves on the SOCRA Board of Directors for the 2025–2028 term. \n\nRead full bio\nKatrina Croghan serves as the Program Director of the Applied Clinical Research Program at St. Cloud State University (SCSU)\, where she leads a curriculum focused on providing comprehensive\, industry-driven knowledge to prepare students for successful careers in clinical research. She also holds the position of Quality Management Coordinator (QMC) at the Mayo Clinic Comprehensive Cancer Center (MCCCC)\, overseeing the establishment\, maintenance\, and education related to all MCCCC documentation\, policies\, and procedures. \nMs. Croghan earned both her B.S. and M.S. degrees from SCSU and has been a Certified Clinical Research Professional (CCRP) since 2014\, accredited by the Society of Clinical Research Associates (SOCRA). She joined the Applied Clinical Research Program at SCSU as adjunct faculty in 2023 and has been with Mayo Clinic since 2012. Her professional journey in clinical research began within the Department of Medicine—Clinical Research Office\, later expanding to the Cancer Center in 2015. There\, she held roles such as Certified Clinical Research Coordinator (CRC)\, Lead CRC\, and Senior CRC\, before advancing to her current QMC role. \nIn recognition of her expertise\, Ms. Croghan attained the rank of Assistant Professor at SCSU in 2025 and was named Assistant Professor of Health Care Administration at Mayo Clinic in 2023. In addition to her primary responsibilities\, she co-chairs the SOCRA Southeast MN Chapter and was recently appointed to the SOCRA Board of Directors for the 2025-2028 term. \n\n\n\n \nJessica Rowe\, MA\, MS\, CCRP\, CIP\nQuality and Education DirectorYale Cancer Center Clinical Trials Office \nJessica Rowe is the Quality and Education Director for the Yale Cancer Center Clinical Trials Office and the Immediate Past President of SOCRA. A CCRP and certified IRB Professional\, she teaches research compliance at the University of Maryland\, Baltimore and is faculty for several SOCRA workshops. \n\nRead full bio\nJessica Rowe\, MA\, MS\, CCRP\, CIP\, is the Quality and Education Director for the Yale Cancer Center Clinical Trials Office. Previously\, she served as the Associate Director for Regulatory\, Compliance\, and Quality at the Yale Center for Clinical Investigation (YCCI) and the Yale Human Research Protection Program (HRPP). Before her tenure at Yale\, Jessica was the HRPP Director for WellSpan Health\, where she managed a comprehensive human research protection program. \nJessica has an extensive 13-year background at the University of Maryland\, Baltimore (UMB)\, where she held multiple roles in the research field and was an active member of several research review committees. She continues to contribute as an IRB member for both UMB and Yale\, and she chairs the Southern Pennsylvania SOCRA Chapter while also serving as the Immediate Past President of SOCRA. \nJessica is an adjunct instructor at the University of Maryland\, Baltimore Graduate School\, teaching courses in research compliance and administration. She is a recognized faculty member in several SOCRA workshops\, including Quality Management and the GCP Prep Course. \nWith extensive experience in human subject research compliance\, IRB\, quality\, clinical trial management\, education\, and training\, Jessica is a Certified Clinical Research Professional (CCRP) and a certified IRB Professional (CIP). She also holds a graduate certificate in Research Ethics from the University of Maryland\, Baltimore. Her passion lies in human subject protections\, bioethics\, quality\, and compliance. \n\n\n\n\n \n\n\nReady to Register?\nSecure your seat through SOCRA Elevate\, SOCRA’s online learning platform. \n\nRegister Now →\n\nQuestions? Contact SOCRA at education@socra.org or 423.424.2814.
URL:https://socra.org/event/ccrp-prep-and-gcp-review-course-5/
LOCATION:Virtual 
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