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Clinical trials

Our catalogue of clinical investigator course contains three chapters on Good Clinical Practice (GCP), the conduct of clinical trials, and clinical research.

Modules Topics addressed Quiz Number of pages
Introduction to GCP Historical background
Initiation to ICH
ICH GCP Document: principles and standards
Shared Responsibilities
Clinical Trial Process: before, during and after a clinical trial
Yes 66 pages
Conduct of clinical trials
Overview of drug development process
Drug Development Process
Product development timeline
Clinical development
Planning and preparation of a clinical trial
Investigator Responsibilities
Resources
Interaction with sponsor
Pre-initiation activities
The initiation visit
Wrap Up
Patient recruitment and enrollment
Recruitment
Enrollment
Informed Consent
Entering subjects
Randomization
Wrap Up
In-trial procedures
Study Documentation
Data Collection
Study Activities
Investigational Product
Retention & Compliance
Wrap Up
Safety in clinical trials
Safety
Adverse Events
Responsibilities
Reporting Adverse Events
Data & Safety Monitoring Board
Managing Adverse Events
Wrap Up
Monitoring and auditing
Quality
Monitoring
Audits & Inspections
Publication, authorship
Wrap Up
Yes 177 pages
Clinical research
Design of clinical trials
Clinical trial design
The clinical trial protocol
Pharmacoeconomics and quality of life
The study of medicinal products in special populations
The ethics and regulations of clinical research
Informed consent and role of ethics committees
International regulatory affairs
Fraud and misconduct in clinical research
The organization of clinical trials
Essential and other required documents
Role of the sponsor in the organization and conduct of the study
International clinical trials and insurance coverage
Management of investigational medicinal product
Data collection and management : To  » e  » or not to  » e  » ?
Role of the different clinical trial committees
Audits and inspections in practice
The analysis of data and publication
Data analysis and interpretation
Final report and publication
Pediatric trials
General guidance
EU regulations
US regulations
Regulations comparison
Drug development
Pharmacokinetics
Ethics I
Ethics II
Drug safety
Challenges
Yes 217 pages