Course Overview
Clinical Research Associate Program + GCP Certificate - CRI001
Clinical Research is one of nation’s most vital undertakings, leading to improved medical care, new preventive methods and improved quality of life for patients. Every year, pharmaceutical companies spend billions of dollars in developing drugs that go through rigorous trials and checks before being introduced in the market. Clinical research professionals play a vital role in the drug development process by conducting, monitoring clinical trials and managing clinical trials within good clinical practice (GCP) guidelines and regulations. It is widely recognized, however, that the efficiency and effectiveness of clinical research professionals depend on strong understanding of regulations and policies that pertain to the conduct and oversight of clinical trials.
The goal of Clinical Research Associate program offered by Clinwell is to develop and train professionals to understand and navigate an array of regulations and policies that pertain to conducting, monitoring and managing clinical trials. The program covers various aspects of a clinical trial from site selection, patient recruitment, choice of the investigator, study conduct, protocols, safety documentations, and study close out. In addition, the program is designed to cover international regulations. Our students learn from some of the best faculty in the industry who are certified practitioners with deep experience in clinical trials and monitoring and have a wide knowledge of ICH-GCP, GMP, GLP and HIPAA.
Chapter 1 |
Introduction: careers in clinical research, drug / medical device approval process |
Chapter 2 |
Pharmaceutical industry overview |
Chapter 3 |
Start clinical research process: drug discovery, drug research. |
Chapter 4 |
Pre-clinical studies of drug / product candidates |
Chapter 5 |
Clinical trial design and regulatory issues |
Chapter 6 |
Phases of clinical trials |
Chapter 7 |
Good clinical practice & international conference on harmonization |
Chapter 8 |
Institutional review board/independent ethics committee (IRB/IEC) |
Chapter 9 |
Clinical trial investigator |
Chapter 10 |
Monitoring of clinical investigations |
Chapter 11 |
Study initiation |
Chapter 12 |
Study monitoring |
Chapter 13 |
Recruitment, retention and compliance |
Chapter 14 |
Study closeout |
Chapter 15 |
Computerized systems used in clinical trials |
Chapter 16 |
Choice of Control Group In Clinical Trials |
Chapter 17 |
Clinical trial sponsor |
Chapter 18 |
Clinical trial protocol & protocol amendment (S) |
Chapter 19 |
Clinical trial investigator's brochure |
Chapter 20 |
Essential documents for the conduct of a clinical trial |
Chapter 21 |
Adverse reactions in clinical trials |
Chapter 22 |
Informed consent |
Chapter 23 |
Safety in clinical trials |
Chapter 24 |
Medical dictionary for regulatory activities (MedDRA) |
Chapter 25 |
Inspection strategy for clinical trials |
Chapter 26 |
Avoiding fraud in clinical trials |
Chapter 27 |
Financial disclosure by clinical investigators |
Chapter 28 |
Safety pharmacology studies for human pharmaceuticals |
Chapter 29 |
Recruitment of volunteers for clinical trials |
Chapter 30 |
Drug advertising |
Chapter 31 |
General principles of pharmacology |
Chapter 32 |
Principles of pharmacodynamics, transduction and neurotransmission |
Chapter 33 |
Kinetic principles of drug administration (Pharmacokinetic) |
Chapter 34 |
Drug interactions and metabolism |
Chapter 35 |
Drugs acting on the sympathetic nervous system (ADRENERGIC DRUGS) |
Chapter 36 |
Antibiotics |
Chapter 37 |
Drugs affecting the coagulation system |
Chapter 38 |
Drugs used in treatment of allergies |
Chapter 39 |
Treatment of central nervous system degenerative disorders |
Chapter 40 |
Drugs for the treatment of viral diseases |
Chapter 41 |
Chemotherapy of neoplastic diseases |
Chapter 42 |
Drugs acting on the parasympathetic nervous system (CHOLINERGIC DRUGS) |
Chapter 43 |
Drugs used in dermatology |
Chapter44 |
Cardiac glycosides,antiarrhythics and drugs, used in ischemic heart disease |
Chapter 45 |
Hormones, vitamins, and minerals. |
Chapter 46 |
Hypotensive drugs and lipids-lowering drugs |
Chapter 47 |
Opioid drugs |
Chapter 48 |
NSAIDs - Nonsteroidal antiinflammatory drugs |
Chapter 49 |
Oncological clinical trials |
Chapter 50 |
Health insurance portability and accountability act (HIPAA) |
