UCC CPD courses

Ethics, Data Management and Quality in Clinical Trials

About

Fact File

Outline

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.

Additional Teaching Mode Information

Compulsory Elements: Continuous Assessment. Online participation in discussions. Written assignment.

Practicalities

For Technical requirements see below

Why Choose

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.

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

2. 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).

3. All applicants will be required to write a 500 word personal statement on why they wish to pursue a career in clinical trials.

4. 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.

5. Applicants may be asked to participate in an interview. 6. 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 http://www.speedtest.net

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). Please note that registered UCC students have access to discounted software from Microsoft and Adobe.

Fees and Costs

€1350.00

How Do I Apply

Applications for this module are now open. 

Application Form:   Application form for HRB CPD Modules

  1.  Download and complete the application form at the link.
  2. Gather any additional documents required (including a passport-style photo)
  3. 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
  4. Send your completed application form, photo and any relevant documents, including your application ID via e-mail to: clinicaltrials@ucc.ie 

Contact details

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