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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.

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 a MSc Clinical Trials. Clinical Trialists, with experience designing, analysing and conducting multicentre, multinational clinical trials, and who bring practical application to teaching (integrating design and analysis of clinical trials), coordinate and teach the Postgraduate Certificate 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.

Entry requirements

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 two 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 two) will be considered on a case-by-case basis by the Clinical Trials Programme team. Such applicants must:
o produce the relevant module syllabi from the awarding institution, and proof of their grades for comparison purposes and
o write a 500 word personal statement on why they wish to pursue a career in clinical trials
o Such applicants may also be asked to participate in an interview. Decisions on selection to the programme will be made on the basis of academic qualifications, personal statement and possibly interview.

Technical Entry Requirements (Online)
This programme will be delivered wholly online. As such, there are specific technical requirements that you need to meet:
• 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). Access to the Canvas Virtual Learning Environment is supported by UCC through IOS and Android apps, which are available from the respective App stores.
• 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
• 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.
• You must have Java and Flash Runtimes installed. Download and installation instructions will be provided.
• 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/

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.

Duration

9 Months Part-Time
Course Delivery Method Online

Careers or further progression

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

Further enquiries

Contact details for this course
Dr Frances Shiely
f.shiely@ucc.ie
+353 21 420 5512
https://www.ucc.ie/en/crfc/staff/

Ms Aoife Quinlan
a.quinlan@ucc.ie
+353 21 420 5577

Subjects taught

• 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)

Assessment method

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.

Application date

Applications for academic year 2020/2021 are open.

EU Applicants: UCC operates a rounds closing date system for the majority of postgraduate taught courses, which means offers are made four times a year on a rolling basis. Some courses have one specific closing date, please check your course prospectus page for this information.

The UCC rounds closing dates for postgraduate taught courses are below. Applicants are advised to apply as soon as possible.

Deadline for receipt of full applications:
For all completed applications received by January 10th 2020
Offers will be made by January 24th 2020

For all completed applications received by March 2nd 2020
Offers will be made by March 16th 2020

For all completed applications received by May 1st 2020
Offers will be made by May 15th 2020

For all completed applications received by July 1st 2020
Offer will be made by July 15th 2020

Late applications may be accepted on a first-come, first-served basis for any courses that have remaining capacity.

Enrolment and start dates

Start Date: 21 September 2020

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