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43 - MDC - Medical Sciences and Clinical Research

MDC 114 - Managing and Monitoring Clinical Trials for GCP Compliance

Code Start Date Duration Venue
MDC 114 06 February 2023 5 Days Istanbul Registration Form Link
MDC 114 03 April 2023 5 Days Istanbul Registration Form Link
MDC 114 29 May 2023 5 Days Istanbul Registration Form Link
MDC 114 24 July 2023 5 Days Istanbul Registration Form Link
MDC 114 18 September 2023 5 Days Istanbul Registration Form Link
MDC 114 13 November 2023 5 Days Istanbul Registration Form Link
MDC 114 04 December 2023 5 Days Istanbul Registration Form Link
Please contact us for fees


Course Description

This course identifies current industry trends and challenges for monitor clinical research associates with a focus on developing tools for handling challenges to effective monitoring and management of clinical trials. Industry standards and best practices will be discussed with an emphasis on the relationship between the Sponsor/CRO and the Investigator/site personnel. The course will teach the different aspects and issues of clinical trial monitoring and management whilst focusing on the standards that Good Clinical Practice (GCP) demands.

Course Objectives

  • Describing various sponsor interpretations of regulations and practical application of ICH guidelines
  • Discussing current trends in clinical research
  • Evaluating and develop more efficient study tracking and management tools
  • Participating more effectively in mentoring and co-monitoring assessments
  • Effectively managing sites, and ensuring their optimum performance
  • Identifying strategies for managing issues including root cause analysis and corrective action 
  • Preparing for monitoring challenges in a global clinical trial
  • Preparing sites for an Regulatory Authority inspection

Who Should Attend?

  • Clinical Research Associates
  • Medical Research Associates seeking to update their knowledge of the GCP
  • Clinical research professionals involved in the management Clinical Research
  • Study/project management professionals

Course Details/Schedule

Day 1

  • Introduction to clinical research and phases of clinical trials
  • Principles of obtaining new medicinal products
  • Methodology of pharmacological research
  • Pre-clinical trials
  • Ethical considerations in clinical trials

Day 2

  •  The aim of clinical trials
  •  Phases of clinical trials
  •  Characteristics and glossary
  •  Sponsor
  •  CRO
  •  CRA
  •  SMO
  •  Investigator/ Institution
  •  Bioethics Committee
  •  EMEA
  •  FDA
  • Clinical trials

Day 3

  • Good Clinical Practice (ICH-GCP)
  • Role and responsibilities of sponsors
  • Role and responsibilities of investigators
  • Role and responsibilities of monitors
  • Essential documents in clinical research
  • Protocol writing


Day 4

  • Pre-study site visits monitoring
  • Site initiation monitoring
  • Routine monitoring visit
  • Case report form review and source document verification
  • Safety reporting monitoring


Day 5

  • Study drug accountability monitoring 
  • Site close-out monitoring 
  • Investigator responsibilities 
  • Informed consent – process & documentation 
  • Investigational site audits