Fairplay Consultants, Inc. - Fundamentals of Clinical Trial Research

Fundamentals of Clinical Trial Research

Description:

A fast-paced, stimulating course designed to teach the basic principles and practices of clinical trials.

Overview:

Fundamentals of Clinical Research is a fast-paced, intensive, practical course designed to teach the basic principles and practices of clinical trial conduct. Participants will be presented with information through workshops, lecture, computer-lab activities and research, role-playing, case studies, and industry learning scenarios. Participants will relate their learning experiences to their everyday work responsibilties during clinical trial conduct -- continual emphasis will be placed on realistic applications.

Who Should Attend:

New entry-level clinical trial research professionals, job-transitioning industry professionals, and ANYONE looking for a refresher course on good clinical practices and ethical clinical trial conduct.

Objectives:

Describe the path of new drug development, from discovery to FDA approval.

Identify the events that led to the evolution of the current regulations and guidelines governing clinical research.

Clarify the purpose of the Protocol and Investigator brochure.

Identify the historical events that led to current ethical codes, which protect human subjects.

Recognize the requirements for informed consent and the role of investigators in the protection of human subjects.

Describe how the privacy and confidentiality of participants of research are protected.

Discuss the role of assurances and voluntary accreditation of research programs in establishing standards of conduct in clinical research.

Explain the difference between paper-based versus EDC based data management processes.

Agenda:

Agenda: Phases of Clinical Research

Regulation of Clinical Research

Medical Device Regulations and Clinical Research

Protecting Human Subjects

Protecting Privacy and Confidentiality of Research Subjects

Roles and Responsibilities/Key Clinical Trial Team Members

The Clinical Protocol & Investigator Brochure

Clinical Trials Management/ Site-Sponsor Interactions

Course materials include CCRP Foundations materials and exam, DCRI textbook and CD-Rom review plus quiz, and FCI Workshops:

* CCRP TEXTBOOK - Covers key issues and regulations affecting the day-to-day conduct of clinical research, a glossary of terms, bibliography, and section tests.

* CCRP WORKBOOK - Includes 10 exercises using a sample Protocol, Investigator Brochure and Case Study. Apply the fundamentals learned in the Textbook to practical application in the daily conduct of a clinical trial.

* CCRP WORKBOOK ANSWER KEY - Provides a discussion of responses addressed in each exercise of the Workbook.

CCRP MEDICAL RECORD AND SOURCE DOCUMENTATION - Includes samples of medical history and physical exam, lab and radiographic test results, progress notes etc. Using the data contained in the source documents, the learner completes an abbreviated case report form.

* CCRP SAMPLE PROTOCOL AND SAMPLE INVESTIGATOR'S BROCHURE

Duke Clinical Research Institute (DCRI) textbook Lessons from a Horse Named Jim Duke Clinical Research Institute (DCRI) CD-Rom review and quiz

FCI Workshops

Please note:

If you would like to see this course offered in your area, please contact us for scheduling opportunities and fees.

For further training in this subject area, please consider:

Human Research Protection Workshop

Notes:

Ethics training is a critical part of the clinical research professional matrix. Consider this course.