Khóa học Chứng chỉ Nâng cao về Nghiên cứu Lâm sàng, Quản lý Dữ liệu Lâm sàng & Cảnh giác Dược

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