Certificate Course in Clinical Research

Topics covered in this course are- Introduction to Clinical Research - History of Clinical Research - Evolution of GCP - ICH, Contents & it's Importance. - Glossary terms - GCP principles - Stake Holders in Clinical Research - Roles & Responsibilities of PI - Roles & Responsibilities of Sponsor - Roles and Responsibilities of EC - 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 - Investigator's Brochure & Protocol - Clinical Trial overviewImportant information about Clinical Research: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:How the body worksHow illness develops in people, such as how diseases get better or worse over timeHow the body handles a possible treatmentWhich behaviors help people stay healthy and prevent illness, and which behaviors raise the chance of illnessThe 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. There are 2 main types of clinical research:Clinical trials, also called interventional studiesObservational studiesBoth may try to learn more about an intervention, which may be a drug, behavior, or medical device.

The main difference is clinical trial participants are assigned to get an intervention, but observational study participants are not assigned to get an intervention. Clinical trialsClinical trials are research studies in which researchers assign participants to get one or more interventions to test what happens in people. Because of this, clinical trials are also called interventional studies.

Often, the intervention is investigational, which means it is not approved for doctors to prescribe to people. In some clinical trials, researchers assign participants to interventions randomly. This means that researchers assign the participants by chance.