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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

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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

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SAHARA Group Training and Consultancy INC (in Turkish: SAHARA Group Eğitim ve Danışmanlık AŞ)

Tax Office: Beyoğlu (Istanbul/Turkiye,Tax No: 7390525151 (Vergi Dairesi: Beyoğlu (İstanbul), Vergi No: 7390525151)

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(Click Category to List Courses)

44 - MDC - Medical Sciences and Clinical Research

MDC 114 - Managing and Monitoring Clinical Trials for GCP Compliance

Course Description

Course Objectives

Who Should Attend?

Course Details/Schedule

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