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Clinical Research Associate Program (GCP Cert.) - Course Contents
Sessions
Session 1 - Introduction: Careers in clinical research - New drug / Medical device approval process
Session 2 - Pharmaceutical Industry Overview
Session 3 - Starting the Clinical Research Process: Drug Discovery and Research
Session 4 - Pre-clinical Research - Pre-Clinical Studies of Drug / Product Candidates
Session 5 - Clinical Study Design – A Good Plan is a Good start!
Session 6 - Phases of Clinical Trials
Session 7 - Good Clinical Practice Guidelines
Session 8 - Institutional Review Board / Independent Ethics Committee (IRB/IEC)
Session 9 - Clinical Trial Investigator
Session 10 - Monitoring of Clinical Investigations
Session 11 - Study Initiation
Session 12 - Study Monitoring
Session 13 - Recruitment, Retention and Compliance
Session 14 - Study Closeout
Session 15 - Computerized systems used in clinical trials.
Session 16 - Choice of Control Group in Clinical Trials
Session 17 - Clinical trial sponsor
Session 18 - Clinical trial protocol
Session 19 - Clinical trial investigator's brochure (IB)
Session 20 - Essential documents for the conduct of a clinical trial
Session 21 - Adverse reactions in clinical trials
Session 22 - Informed consent
Session 23 - Safety in clinical trials
Session 24 - Medical Dictionary for Regulatory Activities (MedDRA)
Session 25 - Inspection Strategy for Clinical Trials
Session 26 - Avoiding Fraud in Clinical Trials
Session 27 - Financial Disclosure by Clinical Investigators
Session 28 - Safety Pharmacology Studies for Human Pharmaceuticals
Session 29 - Recruitment of volunteers for clinical trial
Session 30 - Drug Advertising
Session 31 - General principles of pharmacology
Session 32 - Principles of pharmacodynamics, transduction and neurotransmission
Session 33 - Kinetic principles of drug administration (Pharmacokinetic)
Session 34 - Drug interactions and metabolism
Session 35 - Drugs acting on the sympathetic nervous system (Adrenergic drugs)
Session 36 - Antibiotics
Session 37 - Drugs affecting the coagulation system
Session 38 - Drugs used in treatment of allergies
Session 39 - Treatment of central nervous system degenerative disorders
Session 40 - Drugs for the treatment of viral diseases
Session 41 - Chemotherapy of neoplastic diseases
Session 42 - Drugs acting on the parasympathetic nervous system (cholinergic drugs)
Session 43 - Drugs used in dermatology
Session 44 - Cardiac glycosides, antiarrhythics and drugs, used in ischemic heart disease
Session 45 - Session 45 - Hormones, vitamins, and minerals.
Session 46 - Hypertensive drugs and lipids-lowering drugs
Session 47 - Opioid drugs
Session 48 - NSAIDs - Non-steroidal antiinflammatory drugs
Session 49 - Oncological clinical trials
Session 50 - Health Insurance Portability and Accountability Act (HIPAA)
Kriger Training Center is part of
Kriger International
. Kriger International provides online training for Biopharmaceutical Professionals. Kriger also provides
Clinical Research Management Services
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