Clinical Trials

Course Outline
This Postgraduate Diploma Clinical Trials is suitable for those wishing to pursue a career in clinical trials in the pharmaceutical, medical device or academic sectors. It is a wholly online, part-time course designed for the working professional. Students can expect to dedicate a minimum of 20 hours per week. Study areas include advanced clinical trial design and analysis, regulated clinical trials and pharmacovigilance and management of multicentre studies. On successful completion of these three 10-credit modules, students should be capable of designing and running a multicentre clinical trial.

Course Practicalities
Students of the Postgraduate Diploma Clinical Trials can expect to devote a minimum of 20 hours/week to the course. A guide per 10-credit module is, 80hr(s) directed study (online self-directed learning); 40hr(s) directed study (online moderated activities); 40hr(s) other (written assignment reflection and development (submitted online)); 40hr(s) other (reading and reflective practice). Students will be expected to log-in to Canvas, the virtual learning environment, on a daily basis. Each 10-credit module comprises 200 Marks (pro-rata for larger or smaller modules) divided as follows: Continuous Assessment 200 marks (Online activities and Written Assignment(s)). The compulsory elements are continuous assessment, online participation in discussions and written assignment.

Why Choose This Course
This Postgraduate Diploma Clinical Trials is an online course designed to give a competitive advantage for those wishing to pursue a career in clinical trials in the pharmaceutical, medical device or academic sectors. It is the first such course in Ireland, providing a pathway for progression to an MSc Clinical Trials. Clinical Trialists, with experience designing, analysing and conducting multi-centre, multinational clinical trials, and who bring practical application to teaching (integrating design and analysis of clinical trials), coordinate and teach the Postgraduate Diploma in Clinical Trials. The programme is endorsed by the HRB.

Trials Methodology Research Network. With three 10-week semesters, a week in the middle with no new taught material, this learning experience is designed for busy professionals. Physicians, nurses, pharmacists, dentists, managers, scientists, health scientists, food scientists and workers in the allied health professions are encouraged to apply. Clinical trials is a rapidly expanding discipline with exciting new job opportunities in the healthcare and pharmaceutical sectors, e.g. data manager, clinical research associate, clinical research nurse, project manager, trial monitor, regulatory affairs associate, pharmacovigilance associate etc. Join us on our exciting journey promoting clinical trials and patient-focused research to improve the health of our citizens.

• EH6126 Advanced Clinical Trial Design and Analysis (online) (10 credits)
• EH6127 Regulated Clinical Trials and Pharmacovigilance (online) (10 credits)
• EH6128 Management of Multicentre Studies (online) (10 credits)

Requirements
1. Applicants accepted on the Postgraduate Diploma Clinical Trials are expected to hold an honours Postgraduate Certificate Clinical Trials (minimum Second Class Honours Grade II from UCC).
2. Applicants applying for the Postgraduate Diploma Clinical Trials and who have obtained a Postgraduate Certificate Clinical Trials or Postgraduate Certificate Clinical Research (or equivalent Postgraduate Certificate) from an institution other than UCC (minimum Second Class Honours Grade II) will be considered under Recognition of Prior Learning (RPL) on a case-by-case basis by the Clinical Trials Programme team. Such applicants must:
• produce the relevant module syllabi from the awarding institution, and proof of their grades for comparison purposes and
• write a 500-word personal statement on why they wish to pursue a career in clinical trials
• Such applicants may also be asked to participate in an interview. Decisions on selection to the programme will be made based on academic qualifications, personal statement and possible interview.

Technical Entry Requirements (Online)
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 or later). Access to the Canvas Virtual Learning Environment is supported by UCC through IOS and Android apps, which are available from the respective App stores.
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.

English Language Requirements
Applicants that are non-native speakers of the English language must meet the university approved English language requirements available at https://www.ucc.ie/en/study/comparison/english/postgraduate/

For applicants with qualifications completed outside of Ireland
Applicants must meet the required entry academic grade, equivalent to Irish requirements, available at https://www.ucc.ie/en/study/comparison/

International/non-EU applicants
For full details of the non-EU application procedure please visit our how to apply pages for international students. In UCC, we use the term programme and course interchangeably to describe what a person has registered to study in UCC and its constituent colleges, schools, and departments.

Not all courses are open to international/non-EU applicants, please check the fact file above.

For more information please contact the International Office.

Closing Date: Non-EU Closing Date: 15 June

Open for EU applications, check rounds closing dates under
How to Apply - Application Date Weblink below.

How Do I Apply
1. Choose Course
Firstly choose your course. Applicants can apply for up to two courses under one application. Details of taught courses are available on our online prospectus.

2. Apply Online
Once you have chosen your course you can apply online at the online application portal. Applicants will need to apply before the course closing date. There is a non-refundable €50 application fee for all courses apart from the Education - Professional Master of Education - (Secondary School/Post-Primary Teacher Training) which has a €100 application fee.

Applicants for the Postgraduate Diploma in Public Health Nursing must apply on the PAC website when the programme opens for applications.

3. Gather Supporting Documents
Scanned copies of the following documents will need to be uploaded to the online application portal in support of your application. Applicants may need to produce the original documents if you are accepted onto a course and register at UCC.
• Original qualification documents listed on your application including transcripts of results from institutions other than UCC
• Any supplementary items requested for your course.

Please log into the online application portal for more details.

4. Application processing timeline
Our online application portal opens for applications for most courses in early November of each year. Check specific course details.

5. Rounds
For courses that are in the rounds system (Irish and EU applicants), please check the rounds closing dates.
Additional Requirements
Please note you will be required to provide additional information as part of the online application process for this programme. This will include the following questions:
• You may enter the details of professional or voluntary positions held. We strongly encourage you to complete this section with all relevant work experiences that will support your application.
• Please describe your motivation and readiness for this programme.

Assessments can be expected to comprise of discussion fora (20%), individual project (40%) and other online assessments (40%). Each 10-credit module comprises 200 Marks (pro-rata for larger or smaller modules) divided as follows: Continuous Assessment 200 marks (Online activities 120 marks; and Written Assignment(s) 80 marks). The compulsory elements are continuous assessment, online participation in discussions and written assignment.

9 Months Part-Time
Course Delivery Method Online

Start Date: 21 September 2020

Skills and Careers Information
On completion of the course you can pursue a career in the academic, pharmaceutical or medical device sectors as a
• Clinical Trialist
• Quality Manager
• Project Manager
• Trial Monitor
• Data Associate
• Data Manager
• Clinical Research Nurse
• Clinical Research Associate
• Pharmacovigilance Associate
• Regulatory Affairs Associate