Introduction
This course focuses on patient rights, safety measures, and ethical considerations in clinical research, ensuring adherence to bioethics principles, informed consent, and human subject protection regulations.
Duration:
5 Days
Personal Impact
- Improved ability to handle ethical dilemmas in clinical trials.
- Strengthened understanding of human subject protections.
- Enhanced career opportunities in bioethics and clinical research.
Organizational Impact
- Reduced compliance risks related to patient safety.
- Strengthened ethical credibility and public trust in clinical research.
- Improved adverse event management and regulatory compliance.
Target Audience:
- Clinical researchers and trial investigators.
- Regulatory compliance officers.
- Healthcare professionals involved in research.
Course Level:
Course Objectives
- Ensure patient safety and risk minimization in clinical studies.
- Implement ethical principles, including informed consent.
- Understand adverse event reporting and management.
- Apply GCP and ICH ethics guidelines in trials.
Modules
Module 1: Foundations of Patient Safety and Ethics
- Principles of bioethics and patient rights.
- Historical ethical violations and their impact on regulations.
- Hands-on Exercise: Evaluating ethical issues in past clinical trials.
Module 2: Informed Consent Process and Human Subject Protection
- Components of a legally valid informed consent.
- Vulnerable populations in clinical research.
- Hands-on Exercise: Creating an informed consent document.
Module 3: Adverse Event Reporting and Risk Management
- Identifying serious adverse events (SAEs) and unexpected risks.
- Implementing pharmacovigilance and safety monitoring plans.
- Hands-on Exercise: Developing an adverse event reporting system.
Module 4: Compliance with International Ethical Standards
- Ethical frameworks: Declaration of Helsinki, Belmont Report.
- Ethics committee and Institutional Review Board (IRB) oversight.
- Hands-on Exercise: Writing an ethics review submission.
Module 5: Emerging Trends in Patient Safety and Research Ethics
- AI and digital technologies in clinical ethics.
- Challenges in remote and decentralized clinical trials.
- Hands-on Exercise: Drafting an ethical framework for digital trials.
Related Courses
Course Administration Details:
Methodology
These instructor-led training sessions are delivered using a blended learning approach and include presentations, guided practical exercises, web-based tutorials, and group work. Our facilitators are seasoned industry experts with years of experience as professionals and trainers in these fields. All facilitation and course materials are offered in English. Participants should be reasonably proficient in the language.
Accreditation
Upon successful completion of this training, participants will be issued an Indepth Research Institute (IRES) certificate certified by the National Industrial Training Authority (NITA).
Training Venue
The training will be held at IRES Training Centre. The course fee covers the course tuition, training materials, two break refreshments, and lunch. All participants will additionally cater to their travel expenses, visa application, insurance, and other personal expenses.
Accommodation and Airport Transfer
Accommodation and Airport Transfer are arranged upon request. For reservations contact the Training Officer.
- Email: [email protected]
- Phone: +254715 077 817
Tailor-Made
This training can also be customized to suit the needs of your institution upon request. You can have it delivered in our IRES Training Centre or at a convenient location. For further inquiries, please contact us on:
- Email: [email protected]
- Phone: +254715 077 817
Payment
Payment should be transferred to the IRES account through a bank on or before the start of the course. Send proof of payment to [email protected]
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