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43 - HCM - Healthcare Management & Administration

HCM 122 - Clinical Research Compliance for Health Professionals

Code Start Date Duration Venue
HCM 122 05 August 2024 5 Days Istanbul Registration Form Link
HCM 122 30 September 2024 5 Days Istanbul Registration Form Link
HCM 122 28 October 2024 5 Days Istanbul Registration Form Link
HCM 122 25 November 2024 5 Days Istanbul Registration Form Link
HCM 122 23 December 2024 5 Days Istanbul Registration Form Link
Please contact us for fees


Course Description

There is an increasing need for highly qualified clinical investigators, defined as those participating in patient-oriented, translational, epidemiologic, behavioral, outcomes or health services research. The objective of this course is to provide training for the next generation of healthcare workers in the clinical research arena, providing a platform for more enhanced efficiencies in the translation of medical discoveries into clinical practice. 

Course Objectives

  • Learning the methods required to perform both observational and experimental clinical research
  • Planning and implementing clinical research projects
  • Analyzing interpreting and presenting clinical research data
  • Learning the basic epidemiologic methods involved in clinical research
  • Discussing the principles involved in the ethics of clinical research
  • Learning the legal issues involved in clinical research
  • Knowing about the regulations involved in human subjects research
  • Being familiar with the role of institutional review boards (IRBs) in clinical research
  • Becoming familiar with the principles and issues involved in monitoring patient-oriented research
  • Being able to discuss the infrastructure required in performing clinical research
  • Understanding the steps involved in developing and funding research studies

Who Should Attend?

  • Practicing physicians
  • Junior faculty in clinical departments
  • Residents
  • Academicians
  • Industry and hospital based researchers
  • Those who are interested in the conduct, interpretation and implementation of clinical research 
  • Those who seek to improve the delivery of high quality care and health care policies

Course Details/Schedule

Day 1

  • Statistical Methods, Research and Regulatory Issues
  • Design of Epidemiologic Studies
  • Issues in Randomization
  • Measures
  • Participant Selection
  • Overview of Hypothesis Testing
  • Secondary Data/Meta Analysis
  • Sample Size and Power
  • Conceptual Approach to Survival Analysis
  • Study Development
  • Designing and Testing Questionnaires
  • Efficient Clinical Trials
  • Research with Vulnerable Participants
  • Ethical Principles in Clinical Research 

Day 2

  • Ethical Issues and Regulation of Human Subjects Research
  • Legal Issues in Clinical Research
  • Concepts in the Management of Projects  
  • Evaluation of a Protocol Budget  
  • Human Genome Project and Clinical Research  
  • Data and Safety Monitoring Boards  
  • The Clinical Researcher and the Media  
  • Product Development: Moving from the Bench to the Clinic  
  • FDA Product Regulation

Day 3

  • Monitoring Patient-Oriented Research and Regulatory Issues
  • Data Management in Clinical Trials
  • Information Resources for Clinical Research
  • Quality of Life
  • Scientific Conduct
  • NIH Peer Review Process

Day 4

  • Preparing and Funding a Clinical Research Study- Part I
  • Quality Control in Clinical Trials
  • Clinical Research from the Patient's Perspective
  • Design of Case Report Forms
  • ProtoType and Protocol Mechanics

Day 5

  • Preparing and Funding a Clinical Research Study- Part II
  • Technology Transfer
  • Inclusion of Women and Minorities in Clinical Trials
  • Evaluation of Alternative and Complementary Therapies
  • Health Disparities Research
  • Community-Based Participatory Research