(+20) 11 4444 5474
Date: Thursday, February 5, 2015
Venue: Alexandria University Staff Training Centre, Semouha
Organized by: EgyBiotech for Research and Biotechnology
Map:
Facebook: Clinical Trials Design, Management and Analysis (Module III)

module 3

A modular course in health research based on the University of Leeds postgraduate diploma in health research. It is composed of 6 essential modules and 3 optional modules. Each module is 3 days long. Modules are taught once a month over Thursday, Friday and Saturday.

Aim of the course:

To provide a comprehensive step by step training on all aspects of the research process from idea development till research output.

Type of the course:

Modular course. Each module can be taken as a stand alone module or they can be combined into a full course. The course is composed of 6 essential modules and 3 optional modules which may or may not be selected by candidates for further study. Each module is taught over 2-3 full days.

Target candidates:

Junior researchers, postgraduate degree students, CRAs and research trial coordinators, candidates interested in a research career, mid-career researchers aiming to start independent research projects

Teaching Methods:

plenary session followed by small group activities, problem based learning sessions and practical application in all modules. For full course agenda , see files on event page.

COURSE CONTENT:

Module 3: Clinical Trials Design, Management and Analysis

  • Clinical trial design overview
  • Design of phase I studies, phase II studies and phase III studies
  • Issues in non randomized studies, before and after studies, historical controls and studies comparing paired organs
  • Informed consent and ethical committee approvals
  • GCP guidelines and EU directive for clinical trials
  • Regulatory bodies and licensing
  • How to randomize
  • Controlling for bias and confounding
  • Blinding
  • Inclusion and exclusion criteria, stratification and subgroups
  • End points in clinical trials: pharmacology endpoints, survival endpoints, response endpoints, time to event, quality of life endpoints
  • Interpreting results in clinical trials

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Algalaa street (previously Baby Coca street), Off Alex-Cairo Agricultural Road, Semouha Algadeeda, Alexandria , EGYPT

map(+20) 11 4444 5474