What you'll learn:
- Introduction to Clinical Research
- Careers in Clinical Research, Data Management & Pharmacovigilance
- Drug Development, Phase trials & Regulatory Submissions
- Good Clinical Practices & 13 Principles of ICH GCP
- Fundamentals of Clinical Data Management
- Drug Safety & Pharmacovigilance
- Stakeholders in Clinical Research
- Role of Human Subject in Clinical Trials & Inform Consent Process
- Monitoring in Clinical Trials
- Roles & Responsibilities of Sponsor, Investigator, Site team in Clincial Trials
- Ethics Committee and Role in Subject Safety Protection
- Roles & Responsibilities of Clinical Research Coordinator, Clinical Trial Assistant & Clinical Research Associate
- Clinical Trial Design
- Blinding, Unblinding, Placebo & Randomization in Clinical trials
- Regulatory Submissions, Rules & Regulations
- Essential Documents in Clinical Research
- Terminologies for Adverse Events (AE), Adverse Drug Reactions (ADR) & Serious Adverse Events (SAE) & timelines
This is the ideal course for you if you find are curious about Drug Development Process and want to explore & seek a career in Clinical Research. In order to safeguard the public's health, the pharmaceutical industry is subject to numerous government restrictions, making it one of the most heavily regulated sectors.
Marketing a Drug/Medicinal product that satisfies regulatory criteria is a key goal for the pharmaceutical sector which is achieved through conducting Clinical Trials. Clinical research is medical research that studies people to understand health and disease. Clinical research helps improve the way doctors treat and prevent illness. Through clinical research, researchers learn about important as aspects of the medicine such as
How the Drug Works in the human? How illness develops in people, such as how diseases get better or worse over time? How the body handles a possible treatment & cures of the disease, Which behaviors help people stay healthy and prevent illness, and which behaviors raise the chance of illness The goal is to use science to improve people’s health care and health over time. The participants who join and take part in clinical research studies may or may not get any benefit for themselves.
You will gain a solid understanding of the drug development process, clinical research and related documentation, GCP, and the roles and duties of key clinical research players in a condensed form from this course.
Topics covered in this course are:
- Introduction to Clinical Research
- History of Clinical Research
- Declaration of Helsinki
- Nuremberg Code & Medical Ethics
- Good Clinical Practices (GCP)
- 13 Principles of ICG GCP
- ICH, Contents & it's Importance.
- Glossary terms
- Stake Holders in Clinical Research
- Roles & Responsibilities of PI
- Roles & Responsibilities of Sponsor
- Roles and Responsibilities of EC
- Roles and Responsibilities of Contract Research Organization
- Roles & Responsibilities of CRA, CRC
- Role of Subject in Clinical Trials & Inform Consent process
- Role of RA, Biostatistician & Clinical Data Manger in trials
- Monitoring in Clinical Trials
- Clinical Trial Design
- Essential Documents in Clinical Trials
- Careers & Opportunities in Clinical Research
- Skill Development & Seeking various Careers in Clinical Research
- Investigator's Brochure & Protocol
- Clinical Trial overview
