Program Information:
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
- Explain rules relating to financial disclosure
- Discuss the basics of study design
- Explain the rules and reporting requirements for adverse events and serious adverse events
- Explain study closure procedures and record retention guidelines
- Outline the reasons for monitoring, audits and site visits
- Explain the Food and Drug Administration rules, regulations, and guidelines on research
- Discuss the importance of investigational drug accountability
- Demonstrate and describe how to read clinical reports and records
- Discuss Quality Assurance including, Monitoring and Auditing
- Explain issues that would constitute clinical fraud
The 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.
Agenda:
Eastern Time Zone
Day 1
12:00 to 12:05 Introduction – Disclosure of Relationships
12:05 to 12:35 Study Start-Up: Ethical Foundations
12:35 to 1:00 Study Start-Up: Overview of Research Regulations
1:00 to 2:00 Study Start-Up: Drug Development & Trial Design, Investigational New Drug Application & Expanded Access; Post Market Surveillance
2:00 to 2:15 Break
2:15 to 2:45 Study Start-Up: Device Development
2:45 to 3:25 Conduct of Study: Clinical Protocols; Sponsor Responsibilities
3:25 to 4:00 Conduct of Study: Investigators and Monitors Responsibilities; Financial Disclosure
Day 2
12:00 to 12:05 Join Webinar
12:05 to 12:50 Conduct of Study: Institutional Review Board
12:50 to 2:00 Conduct of Study: Informed Consent
2:00 to 2:10 Break
2:10 to 2:50 Conduct of Study: Managing Study Compliance; Safety Reporting
2:50 to 3:00 Study Close-Out: Study Closure/Record Retention; Regulatory Submission
3:00 to 3:50 Conduct of Study: Inspections and Audits
3:50 to 4:00 Resources and Final Questions
Faculty Bios:
Laura Holtz, MS, PMP, CCRP
Laura 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.
Katrina A. Croghan, M.S., CCRP
Katrina 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.
Ms. 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.
In 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.
Jessica Rowe, MA, MS, CCRP, CIP
Jessica 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.
Jessica 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.
Jessica 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.
With 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.