UCC CPD courses

Introduction to Clinical Trial Design and Analysis EH6124

About

Fact File

Outline

Module Objective: Students will learn the fundamental elements of clinical trial design.

Module Content: Review of basic probability theory; frequentist statistical inference; causal inference in clinical trials; sample selection; randomization; allocation concealment; outcomes; baselines and covariates; sample size and power; 2-arm parallel trials; linear models; regulatory advice on trial design and analysis.

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

  • Describe the value of concurrent controls with reference to specific examples.
  • Describe the value of randomisation in a clinical trial, with reference to both statistical and causal inference.
  • List the information needed to calculate a sample size, explain what study power is and how to achieve it, and demonstrate the ability to calculate a sample size when provided with the necessary inputs.
  • Demonstrate how inappropriate categorisation impacts the power of a study.
  • Compare and contrast the use of change scores as an outcome with adjustment for baseline outcome.
  • Discuss the usefulness of covariate adjustment.
  • Explain the importance of allocation concealment for the integrity of a trial, and evaluate commonly used methods for achieving it.
  • Apply what was learned over the course to design a 2-arm parallel trial.

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).

Dr Brendan Palmer, School of Medicine, HRB Clinical Research Facility, UCC; Dr Frances Shiely, School of Public Health, HRB Clinical Research Facility, UCC; Dr Darren Dahly, School of Medicine, HRB Clinical Research Facility, UCC.

Practicalities

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).

Requirements

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

  1. Download and complete the application form at the link below.
  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 cpdgraduatestudies@ucc.ie

Applications for this module are currently open.

CPD Co-ordinator,

CPD Centre, 

An tIonad um Fhorbairt Ghairmiúil Leanúnaigh,

Q+1 floor, The Boole Library, Main Quad, U.C.C.

OR via email at cpdgraduatestudies@ucc.ie

Apply Now

Contact details

Top