Ethics, Data Management and Quality in Clinical Trials EH6125 (10 Credits)
Part-Time. See Additional Teaching Mode Information for more info.
É1,350 See Fees and Costs for full details.
See Requirements for full details.
31st October 2021
Module Objective: To outline the ethical principles and requirements in the conduct of clinical trials and to introduce students to the principles and practical issues involved in data management and quality in clinical trials.
Module Content: History of ethics in clinical research; the Declaration of Helsinki; introduction to quality concepts (QA/QC); 13 principles of ICH-Good Clinical Practice leading to certification; good data management practices.
Learning Outcomes: On successful completion of this module, students should be able to:
- Outline relevance of quality control in clinical trials.
- Describe the history of ethics in clinical research.
- Complete an ethics application for a research study.
- Describe basic elements of quality and how they apply to clinical trials.
- Outline the 13 Principles of ICH-GCP.
- Describe Investigator responsibilities as per ICH-GCP
- Construct a Corrective and Preventative action plan (CAPA) for a non-conformance.
- Explain the role of data management in clinical trials.
- Discuss the critical elements of good data management practices in Clinical trials.
Additional Teaching Mode Information
Teaching Method(s): 40hr(s) Directed Study (online moderated activities); 80hr(s) Other (online self-directed learning); 40hr(s) Other (written assignment reflection and development (submitted online)); 40hr(s) Other (reading and reflective practice).
Lecturer(s): Ms Máire McCarthy, Department of Medicine, HRB Clinical Research Facility, UCC; Dr Frances Shiely, School of Public Health, HRB Clinical Research Facility, UCC; Dr Ruben Eavan Keane, School of Medicine, HRB Clinical Research Facility, UCC; Dr Darren Dahly, School of Medicine; Dr Brendan Palmer, School of Public Health.
Continuous Assessment. Online participation in discussions. Written assignment.
Fees and Costs
The fee for this module is €1,350.00. There is also a €35 application fee.
How Do I Apply
To apply for this module please download and complete the application form below:
Application Form 03 03 21 CPD Form
- Download and complete the application form at the link below.
- Gather any additional documents required (including a passport-style photo).
- Pay your €35 application fee for this module via UCC’s Online Portal, noting your Application ID: Click here to proceed to UCC’s Online Portal.
- Send your completed application form, photo and any relevant documents, including your application ID via e-mail to firstname.lastname@example.org
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