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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 Fees
MDC 114 06 December 2020 5 Days Istanbul $ 3450 Registration Form Link
MDC 114 31 January 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 114 28 February 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 114 28 March 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 114 25 April 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 114 23 May 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 114 20 June 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 114 15 August 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 114 12 September 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 114 10 October 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 114 07 November 2021 5 Days Istanbul $ 3450 Registration Form Link
MDC 114 05 December 2021 5 Days Istanbul $ 3450 Registration Form Link
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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