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Introduction to Clinical Trials Stage 2 – Beginners
Introduction to Clinical Trials Stage 2 – Beginners
Curriculum
7 Sections
23 Lessons
10 Weeks
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Module 1: Fundamentals of Clinical Research
4
1.0
Chapter 1: Introduction to Clinical Research – This chapter discusses what clinical trials are, their purpose, and their importance in advancing medical science.
1.1
Chapter 2: Types of Clinical Studies – Explains the differences between observational vs. interventional studies, and randomized vs. non-randomized trials.
1.2
Chapter 3: Ethical and Legal Aspects – Review the ethical guidelines and legal regulations governing clinical research, including the Helsinki Declaration and Good Clinical Practice (GCP).
1.4
🎦
Module 2: Designing Clinical Studies
4
2.0
Chapter 1: Planning and Designing Studies – Focuses on the essential elements of effective study planning, including hypothesis formulation and methodology selection.
2.1
Chapter 2: Population Selection and Participant Recruitment – Discuss inclusion and exclusion criteria, as well as methods of participant recruitment.
2.2
Chapter 3: Data Management in Clinical Trials – Covers strategies for data collection, storage, and analysis in clinical trials.
2.3
🎦
Module 3: Roles and Responsibilities in Clinical Research
4
3.0
Chapter 1: Study Sponsor – Details the role, duties, and responsibilities of the study sponsor.
3.1
Chapter 2: Contract Research Organization (CRO) – Describes how CROs support clinical trials, including the range of services they offer.
3.2
Chapter 3: Roles and Responsibilities in Clinical Research – Explains the structure of research centers and the roles and responsibilities of each team member.
3.3
🎦
Module 4: Conducting Clinical Research
4
4.0
Chapter 1: Phases of Clinical Trials – Provides a detailed overview of the different phases of clinical trials, from pre-clinical to phase IV.
4.1
Chapter 2: Ensuring Integrity: Oversight and Quality Assurance in Clinical Trials – Provides an in-depth exploration of how clinical trials are monitored and controlled for quality, detailing the roles of systems like IWRS and the responsibilities of vendors and other stakeholders in ensuring data integrity and regulatory compliance.
4.2
Chapter 3: Risk Management in Clinical Trials – Addresses the identification, analysis, and management of risks in clinical trials
4.3
🎦
Module 5: Regulatory Compliance and Practical Applications
4
5.0
Chapter 1: Regulatory Compliance – Discusses the critical regulations that govern clinical research, including detailed information on regulatory bodies like the FDA and EMA, and the processes for obtaining approval for clinical trials.
5.1
Chapter 2: Practical Applications of Clinical Trial Results – Explores how the results of clinical trials are applied in medical practice, including drug approval processes, label changes, and the impact on clinical guidelines.
5.2
Chapter 3: Ethical Considerations and Patient Safety – Focuses on the ethical issues in clinical research, such as informed consent, patient safety measures, and the role of ethics committees.
5.3
🎦
Quiz
1
6.1
Introduction to Clinical Research Stage 2 – Beginners: Quiz
15 Questions
Premium Materials Included in Your Course Package:
3
7.1
What is IWRS
7.2
Documentation in Clinical Trials and ALCO+
7.3
eCRF
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