• views: 106
• date: 26 September 2023
• posted by: mitsumi

What you'll learn
Ethical principals guiding clinical research and regulatory requirements of IRB related to research study start up, implementation and closure
4 weeks
Critically think over protocols.
Review research protocols with me to apply principles learnt in the course.
Define the roles and responsibilities of IRB, FDA, sponsors, and investigators along with overseeing the overall operational workflow.
Requirements
A brief professional experience in clinical research
Description
This intensive program is designed to equip aspiring CRAs with the knowledge, skills, and confidence needed to excel in the dynamic field of clinical research. I leveraged up-to-date research and ongoing discussions regarding FDA rules and regulations, making use of easily accessible FDA and federal laws that are available online. I conveyed all information through video presentations in, concise downloadable notes, and high order thinking questions in English.The course encompasses: Fundamentals of Clinical Research: Gain a solid foundation in the principles and regulations governing clinical research, including Good Clinical Practice (GCP) guidelines.Clinical Trial Management: Learn the end-to-end process of planning, conducting, monitoring, and reporting on clinical trials.Ethical and Regulatory Compliance: Explore the ethical considerations and regulatory requirements that govern human subject research.Quality Assurance and Auditing: Understand how to maintain the highest standards of quality and compliance within clinical research projects.Risk Assessment and Mitigation: Identify potential risks in clinical trials and develop strategies to mitigate them effectively.Protocol and Investigator Interaction: Learn to collaborate with investigators and research teams to ensure study success.Exam Readiness: Benefit from practice exams, quizzes, and real-world case studies to enhance your exam preparedness.Upon completing this course, you'll be well-prepared to tackle the Clinical Research Associate certification exam with confidence. Join us and take the first step towards a rewarding career in clinical research. Your future as a CRA starts here!
Overview
Section 1: Introduction
Lecture 1 Introduction to CCRP and SOCRA- Nuremberg code
Lecture 2 Introduction to CCRP and SOCRA- Belmont Report
Lecture 3 45 CFR 46
Section 2: Start up (40% of exam question)
Lecture 4 consent and subject information documents, financial disclosure, case forms
Lecture 5 Evaluate research study's compliance with relevant local, and state laws
Lecture 6 Basic Term: Risk to Human Subjects
Section 3: Implementation (45%)
Lecture 7 execute research strategy
Lecture 8 Manage research study product
Lecture 9 You'll find abundant resources attached with lessons in the upcoming section!
Lecture 10 managing adversities during the study
Lecture 11 Manage subjects
Lecture 12 Maintain research study
Lecture 13 Communication with stakeholders
Lecture 14 Study closure
Aspiring Clinical Research Associates, students volunteering in research, journal reviewers and editors.,People with brief professional experience in clinical research looking to expand their horizon and find out what lies beyond the barrier.

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