Clinical Trials Management
( 25 Modules )

Module #1
Introduction to Clinical Trials
Overview of clinical trials, their importance, and the role of clinical trials management

Module #2
Regulatory Framework
International and national regulations governing clinical trials, including ICH, FDA, and EU directives

Module #3
Clinical Trial Phases
Pre-clinical, Phase I-IV, and post-marketing phases of clinical trials, including study design and objectives

Module #4
Clinical Trial Components
Protocol, informed consent, case report forms, and other essential documents in clinical trials

Module #5
Good Clinical Practice (GCP)
Guidelines for conducting clinical trials, including ethics, safety, and quality control

Module #6
Clinical Trial Planning
Developing a clinical trial plan, including budgeting, timelines, and resource allocation

Module #7
Site Selection and Feasibility
Selecting and evaluating clinical trial sites, including feasibility assessments and site visits

Module #8
Investigator and Site Initiation
Identifying and initiating principal investigators, including training and responsibilities

Module #9
Clinical Trial Supply Management
Managing clinical trial supplies, including investigational products and equipment

Module #10
Risk Management and Quality Control
Identifying and mitigating risks, including quality control measures and contingency planning

Module #11
Clinical Trial Conduct
Conducting clinical trials, including patient recruitment, data collection, and trial management

Module #12
Monitoring and Quality Assurance
Monitoring clinical trials, including on-site monitoring, remote monitoring, and quality assurance

Module #13
Data Management and Biostatistics
Managing and analyzing clinical trial data, including data cleaning, validation, and statistical analysis

Module #14
Adverse Event Reporting and Pharmacovigilance
Reporting and managing adverse events, including pharmacovigilance and safety monitoring

Module #15
Clinical Trial Amendments and Updates
Managing changes to clinical trials, including protocol amendments and updates

Module #16
Clinical Trial Close-out
Closing out clinical trials, including finalizing data, archiving documents, and site closure

Module #17
Clinical Trial Reporting
Generating clinical trial reports, including study results, and submitting to regulatory authorities

Module #18
Regulatory Submissions and Approvals
Preparing and submitting regulatory submissions, including NDA, BLA, and CE mark applications

Module #19
Publication and Dissemination of Results
Publishing and disseminating clinical trial results, including journal articles and conference presentations

Module #20
Post-Marketing Surveillance and Vigilance
Conducting post-marketing surveillance and vigilance, including safety monitoring and reporting

Module #21
Global Clinical Trials
Conducting clinical trials in multiple countries, including cultural and regulatory considerations

Module #22
Pediatric and Geriatric Clinical Trials
Conducting clinical trials in special populations, including pediatric and geriatric considerations

Module #23
Innovative Clinical Trial Designs
New and innovative approaches to clinical trial design, including adaptive designs and basket trials

Module #24
Clinical Trial Technology and Data Analytics
Leveraging technology and data analytics in clinical trials, including electronic data capture and wearable devices

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Clinical Trials Management career

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Clinical Trials Management ( 25 Modules )

Clinical Trials Management
( 25 Modules )