Course Description

The 20-Hour Fundamentals of Clinical Research Series provides a comprehensive introduction to clinical research for newly hired clinical research professionals or individuals interested in working in the pharmaceutical and medical device industry. Participants will learn about the basics of clinical research. The series covers core sponsor and investigator site activities to help learners understand the key considerations in the real-life work of clinical researchers. This course covers FDA regulations, the importance of ICH GCP, protocol development, monitoring in clinical research, and the identification and reporting of adverse events. Activities in the course include interactive discussions, knowledge checks, and a final course practicum exercise.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

• Define clinical research and discuss how preclinical development leads to clinical development
• Explain the roles and responsibilities of all members of the clinical team: Sponsor, vendor, CRO, investigator, Institutional Review Board, subject and regulatory authority
• Describe the investigational product development process, including study design and the logic involved
• Define the regulatory requirements, including principles of Good Clinical Practice from the International Council for Harmonization, FDA regulations (Code of Federal Regulations), ethical considerations for a study and the need for Standard Operating Procedures
• Define the steps involved in proceeding with the study: Sponsor development of protocol, case report form, informed consent document, budget, database and identifying an investigational site
• Describe the conduct of the study, including monitoring visits to the site and site performance management and communication
• Describe the management of adverse events and completion of study reporting and retention of documents
• Identify career opportunities and reference materials available

Course Outline

• Module 1: Clinical Research: Protection of the Human Research Subject and ICH GCP
• Module 2: The Clinical Research Team: Roles and Responsibilities of the FDA, Sponsor, CRO, Clinical Investigator, CRA, CRC, and IRB/IEC
• Module 3: Development of New Products: How are new drugs and medical devices developed?
• Module 4: The Protocol: Understanding the Contents and Purpose of the Protocol in Clinical Research
• Module 5: Selection of the Clinical Investigator: Process and Procedures, Informed Consent, and Monitoring Visits
• Module 6: Safety in Clinical Trials: Understanding Adverse Events and Reporting Requirements
• Module 7: Clinical Research: Recruitment of Subjects, Good Documentation Practices, Essential Documents, and Source Documentation
• Module 8: Submission to Regulatory Authorities: Process for Approval of New Drugs and New Medical Devices
• Module 9: FDA Inspections: Understanding Purpose and Procedures
• Module 10: Course Practicum and Overview of Career Pathways

Who Should Attend

• Those who are new to clinical research
• Aspiring Clinical Research Coordinators and Clinical Research Associates
• Nurses interested in clinical research
• Aspiring and Entry Level Project Managers (looking to gain experience in clinical research)
• College Students and New Graduates in a Scientific Field

NOTE: This course is for individual registrants only and does not allow for group training.

What previous students have said ...

“The course was great and I learned a great deal. The course was perfectly suited to my requirements and gave me the insight that I wished for. Thank you.”

"I’ve been working as a CTA for 9 months now, it was good to get a solid overview of the clinical research process. I learned more about FDA & ICH which will be helpful."

“I now have a much clearer overview of the various roles and responsibilities as well as the overall clinical research process.”

Instructors

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A.,T.I.A.C.R.

Sonja Cooper, Ph.D., M.B.A.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Elizabeth Weeks-Rowe, LVN, C.C.R.A.

Click here for complete trainer biographies

Course Length and Time

Two 2-Hour classes each week for 5 weeks

Registration Fees

$1,695 by Early Bird Deadline

$1,895 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 20 hours (2.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-009-L99-P. Released: 1/24.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.