INTRODUCTION
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.
PROGRAM 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
PROGRAM OUTLINE
- 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
- The aim of clinical trials
- Phases of clinical trials
- Characteristics and glossary
- Sponsor
- CRO
- CRA
- SMO
- Investigator/ Institution
- Bioethics Committee
- EMEA
- FDA
- Clinical trials
- 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
- Pre-study site visits monitoring
- Site initiation monitoring
- Routine monitoring visit
- Case report form review and source document verification
- Safety reporting monitoring
- Study drug accountability monitoring
- Site close-out monitoring
- Investigator responsibilities
- Informed consent – process & documentation
- Investigational site audits
Permintaan Brosur penawaran Training
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