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44 - MDC - Medical Sciences and Clinical Research


MDC 114 - Managing and Monitoring Clinical Trials for GCP Compliance

Code Start Date Duration Venue
MDC 114 02 December 2024 5 Days Istanbul Registration Form Link
MDC 114 06 January 2025 5 Days Istanbul Registration Form Link
MDC 114 03 March 2025 5 Days Istanbul Registration Form Link
MDC 114 28 April 2025 5 Days Istanbul Registration Form Link
MDC 114 23 June 2025 5 Days Istanbul Registration Form Link
MDC 114 18 August 2025 5 Days Istanbul Registration Form Link
MDC 114 13 October 2025 5 Days Istanbul Registration Form Link
MDC 114 08 December 2025 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

 

ETABS and SAFE. Training 24 CCE 210 5 SAP 2000. Training 25 CCE 305 5 Quality Assurance in Pavement Construction 26 CCE 401 5 Construction Project Management 27 CCE 402 10 Construction Project Management (10 Days) 28 CCE 403 5 Construction Project Management-Intensive 29 CCE 405 5 Principles of Construction Project Management 30 CCE 406 10 Principles of Construction Project Management (10 Days) 31 CCE 410 10 Construction Project and Risk Management (10 days) 32 CCE 411 5 Project & Contract Management for Marine Construction 33 CCE 412 5 Application of GIS in Construction Management 34 CCE 415 4 Sustainable Water Management Techniques, Innovation and Solution (4 Days) 35 CCE 419 5 Construction Management of Hydraulic Projects 36 CCE 420 5 Water Project Management 37 CCE 421 10 Modern Technologies in the Supervision and Quality Control of Irrigation Projects and Dealing with Contractors (10 Days) 38 CCE 422 5 Rapid Earthquake Hazard Evaluation of Buildings 39 CCE 425 10 Practical Application of Computers in Structural Engineering (10 Days) 40 CCE 428 5 Survey & Profile Using Total Station 41 CCE 430 5 Bridge Construction and Maintenance 42 CCE 435 5 Bridge Inspection and Maintenance 43 CCE-A 410 10 إدارة المشاريع الهندسية -10 أيام
21 - TTC - Transportation and Traffic Control
22 - ADV - Architectural Design and Visualization
23 - SRM - Safety and Occupational Health
24 - CSM - Public Relations, Communication Skills & Office Management
25 - TEM - Training and Education Management
26 - CMR - Customer Relations