Program Overview

Ethics, Data Management and Quality in Clinical Trials

Course Fact File

• Code: EH6125
• Duration: January to March 2025
• Teaching Mode: Part-Time
• Fees: €1350.00
• Closing Date: 24/11/2025
• Start Date: 05/01/2026

Outline

Module Objective

To outline the principles and practical issues involved in data management and quality in clinical trials, centred on the application of good clinical practice and research ethics.

Module Content

• Development of data management plans
• FAIR data guiding principles
• Data protection regulations
• Ethics applications
• Introduction to quality concepts (QA/QC)
• 13 principles of ICH-Good Clinical Practice leading to certification

On successful completion of this module, students should be able to:

1. Explain the role of data management in clinical trials.
2. Discuss the critical elements of good data management practices in clinical trials.
3. Outline the relevance of quality control in clinical trials.
4. Describe basic elements of quality and how they apply to clinical trials.
5. Outline the 13 Principles of ICH-GCP.
6. Describe Investigator responsibilities as per ICH-GCP.
7. Construct a Corrective and Preventative action plan (CAPA) for a non-conformance.
8. Complete an ethics application for a research study.
9. Construct a sample data management plan for a research study.

Practicalities

• 33 Hr(s) Directed Learning
• 20 Hr(s) Online Asynchronous (Any Time Learning) Activities
• 145 Hr(s) Independent Enquiry

Assessment:

• Total Marks 200
• Discussion Board(s) - Contribution to online discussion boards as prescribed (20 Marks)
• Assignment - Written assignment(s) submitted online (100 Marks)
• Quiz(zes) - Online MCQ's (80 Marks)

Why Choose

EH6125 is one of the modules of the Postgraduate Certificate in Clinical Trials.

This programme is designed for the working professional who wishes to develop a career in clinical trials.

As part of UCC's commitment to Continuing Professional Development (CPD), Holders of CPD certificates for clinical trial modules in UCC will be exempt from these modules within the Postgraduate Certificate if they undertake the Postgraduate Certificate within 24 months of completion of any CPD module.

Requirements

Academic Requirements

1. Students are expected to hold an honours primary degree (NFQ Level 8), minimum second class honours grade 2, or equivalent, in a Science or health related discipline, or relevant subject area.

Professional Requirements

1. Also open to registered health care professionals in Medicine, Nursing, Pharmacy and Allied Health care disciplines who may not have a primary degree. Such applicants must provide evidence of current registration with the relevant professional regulatory body in their country (e.g. the Irish Medical Council, the Nursing and Midwifery Board of Ireland, the Pharmaceutical Society of Ireland etc. for Irish applicants).
2. All applicants will be required to write a 500 word personal statement on why they wish to pursue a career in clinical trials.
3. In exceptional circumstances, candidates with an honours primary degree (NFQ Level 8 or international equivalent) in an unrelated field, and who can demonstrate relevant experience in clinical research, may be considered for entry to the programme, subject to the approval of the programme team.
4. Applicants may be asked to participate in an interview.
5. In all cases, decisions will be based on qualifications and quality of application.

Technical Entry Requirements (Online)

This programme will be delivered wholly online. As such there are specific technical requirements that you need to meet.

1. You will need access to a laptop or desktop (either Mac OS or Windows) running a relatively recent operating system (Windows 7, 8, 8.1, 10 or Mac OSX 10.8, 10.9, 10.10). Tablets and smartphones are not officially supported by UCC.
2. You will need access to a reliable broadband connection with at least 2MB download speeds. You can test your broadband or 4G speeds by visiting.
3. You must have a modern web browser installed. The most reliable options for use with UCC online learning are Mozilla Firefox and Google Chrome. Download and installation instructions will be provided. Safari is not suitable.
4. You must have Java and Flash Runtimes installed. Download and installation instructions will be provided.
5. You will require an Office suite of software (Microsoft Office 2003 or later or equivalent) and a PDF reader (preferably Adobe Acrobat Reader XI or later).

Fees and Costs

€1350.00. There is also a €35 application fee.