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 |