Mode: Online
Duration: 30 hours (Self-paced)
Eligibility: B.sc, M.sc (Life science), Nursing, B.pharm & M.pharm Graduates and appearing.
📝 Course Description
Clinical research is at the heart of advancing modern medicine. This course offers an in-depth introduction to the core principles, ethical frameworks, and regulatory structures that govern clinical trials. Designed for beginners and healthcare professionals alike, this course will equip you with the knowledge to understand, design, and evaluate clinical studies in real-world healthcare settings.
Whether you’re aspiring to enter the pharmaceutical industry, contribute to public health, or support research in clinical settings, this course builds a strong foundation to help you begin your journey into the world of clinical research.
🎯 What You Will Learn
- Understand the purpose of clinical research
- Explore the history and evolution of clinical trials
- Learn about Good Clinical Practice (GCP), ethics, and informed consent
- Identify key stakeholders: sponsors, investigators, regulators, and CROs
- Understand Indian and international regulations (ICH-GCP, CDSCO, USFDA
- Get introduced to trial monitoring, documentation, and auditing
👥 Who Should Enroll
- Students of Life Sciences, Pharmacy, Nursing, Medicine, Public Health
- Fresh graduates seeking entry into Clinical Research or Pharma sectors
- Working professionals looking to upskill in clinical trial process
Curriculum
- 7 Sections
- 25 Lessons
- 30 Hours
- 1. Introduction to Clinical ResearchClinical research refers to systemic investigation in a human being for evaluating the safety and efficacy of a new drug. As various diseases are increasing day producing threat to human being and treatments available to treat them are limited, the necessity for new drug development has amplified.4
- History of Clinical Trial Process and Development of GCPMany of the drugs that are used today have been discovered in the past by research and trialand- error activities with different structured. Thus, we can say that, research and the trial is a root cause of modern medicine: In fact, clinical trial is key link between mankind and life saving medicines and it has given number of effective medicines to the society. Few important events and incidences from the past have constituted the pillars of today’s drug development system. Similarly, number of other events has also helped for the improvement in Good Clinical practice (GCP) standard for conduct of clinical trials.4
- Glossary: Important DefinitionsClinical trial is a very important step in drug development process as it deals with human beings. Hence, it is necessary to understand the basic terminologies; as these terminologies have regular application in clinical trials. The following glossary was prepared to help the consumer become familiar with many of the common terms used in clinical trials.3
- StakeholdersThe successful execution of a clinical trial means the project is finished on time, on budget and has a high level of quality. It only figures that these objectives would be possible to achieve only when trial has an effective and robust team. This team not only includes the individual/[s] those who are part of group during the conduct of trial but also involvement of people from organizing the trial till marketing the drug.9
- 5 . Indian Regulations for Clinical TrialsIndian Regulations for Clinical Trials1
- PharmacovigilancePharmacovigilance2
- Guideline & Law Governing PharmacovigilanceGuideline & Law Governing Pharmacovigilance2
