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 overview

Important 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 works

• How illness develops in people, such as how diseases get better or worse over time

• How the body handles a possible treatment

• 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.

There are 2 main types of clinical research:

• Clinical trials, also called interventional studies

• Observational studies

Both 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 trials

Clinical 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. Usually, participants (or their doctors) don't choose what intervention they will get when they join a clinical trial.

Career opportunities in the clinical research field:

Career opportunities in the clinical research field are many and varied, with employment settings ranging from pharmaceutical and biotechnology, to medical device companies, contract research organizations, hospitals, educational institutions, independent contractors and more.

1. Clinical research coordinator

Also called research nurses, site managers and clinical study coordinators, clinical research coordinators (CRCs) are responsible for the daily operations of clinical research studies at sites like hospitals, independent medical practices, universities, medical schools and other research companies and institutions. CRCs may provide direct care or treatment to patients participating in a study, work with the study’s principal investigators, recruit study subjects and more. The background of most CRCs is in nursing and other healthcare professions.

2. Clinical research associate

The clinical research associate or CRA, also called a clinical monitor or trial monitor, works with clinical trial sites to monitor studies and ensure that standard regulatory, operations and ethical standards are being followed. CRAs may be employed by pharmaceutical companies, government research agencies or medical research institutes, and often travel between study sites for monitoring visits, as well as conducting virtual visits. CRAs often obtain their clinical research experience through working several years as CRCs.

3. Clinical research data specialist

The importance of data management and analysis in clinical research cannot be overstated. This includes data from research studies and electronic medical records, as well as other data from disparate systems and sources. Opportunities around clinical research data include data analyst, data manager, data coordinator, data associate and more.

4. Clinical investigator or clinical researcher
5. Research pharmacist

Life scientists, physicians, pharmacists and other scientists are at the core of clinical research. Their work drives the innovations and breakthroughs that result in improved outcomes and treatments for current and future patients. Roles may include research scientist or investigator as part of a research team or as principal investigator, lead scientist, etc.

6. Clinical project manager

Clinical research is a complex enterprise with multiple stakeholders, teams, tasks and challenges. Clinical trials project managers must have an advanced understanding of project management techniques and methodologies and apply them to coordinate all aspects of a clinical study.

7. Clinical laboratory technologist or technician

8. Medical laboratory scientist

Medical laboratory technologists and scientists are directly involved in preparing and analyzing research specimens in the lab. They may be employed in hospital-based research labs, pharmaceutical and biomedical companies, or other research institutions. Medical laboratory technicians usually have an associate degree and advance to medical laboratory scientist with a bachelor’s degree and experience in the field.

9. Medical/scientific writer
10. Marketing and communications professional

Writing, marketing and communication professionals with a medical or scientific background play a vital role in research. They write materials for scientific publications and other documents such as abstracts, posters, manuscripts, scientific presentations. They may be involved in grant-writing, publicity campaigns, scientific documentation, patient and stakeholder communications, and more.