The CRA Institute

Preparing Professionals for Clinical Research Since 1989

THE CRA/CRC course outline

        Course overview                                            Course Brochure                                course enrollment 

MODULE 1

  • THE Drug Approval Process
  • OVERVIEW OF THE Pharmaceutical Industry
  • THE Clinical Research Process: Drug Discovery, Drug research.

MODULE 2

  • Pre-clinical Research Pre-Clinical Studies of Drug / Product Candidates
  • Investigational New Drug Application (I.N.D.) and New Drug Submission (NDS)
  • Phases of Clinical Trials

MODULE 3

  • Good Clinical Practice & International Conference on Harmonization
  • INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
  • CLINICAL TRIAL INVESTIGATOR

MODULE 4

  • MONITORING OF CLINICAL INVESTIGATIONS
  • Study Initiation
  • Study Monitoring

MODULE 5

  • Recruitment, Retention and Compliance
  • Study Closeout
  • COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS

MODULE 6

  • Choice of Control Group In Clinical Trials
  • CLINICAL TRIAL SPONSOR
  • CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT (S)

MODULE 7

  • CLINICAL TRIAL  INVESTIGATOR'S BROCHURE
  • ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL
  • ADVERSE REACTIONS IN CLINICAL TRIALS

MODULE 8

  • INFORMED CONSENT
  • SAFETY IN CLINICAL TRIALS
  • Medical Dictionary for Regulatory Activities (MedDRA)

MODULE 9

  • Inspection Strategy for Clinical Trials
  • Avoiding Fraud in Clinical Trials
  • Financial Disclosure by Clinical Investigators

MODULE 10

  • Safety Pharmacology Studies for Human Pharmaceuticals
  • recruitment of volunteers for clinical trials
  • Drug Advertising

MODULE 11

  • GENERAL PRINCIPLES OF PHARMACOLOGY
  • PRINCIPLES OF PHARMACODYNAMICS, TRANSDUCTION AND NEUROTRANSMISSION
  • KINETIC PRINCIPLES OF DRUG ADMINISTRATION (Pharmacokinetic)

MODULE 12

  • DRUG INTERACTIONS AND METABOLISM
  • DRUGS ACTING ON THE SYMPATHETIC NERVOUS SYSTEM (ADRENERGIC DRUGS)
  • ANTIBIOTICS

MODULE 13

  • DRUGS AFFECTING THE COAGULATION SYSTEM
  • DRUGS USED IN TREATMENT OF ALLERGIES
  • TREATMENT OF CENTRAL NERVOUS SYSTEM DEGENERATIVE DISORDERS

MODULE 14

  • DRUGS FOR THE TREATMENT OF VIRAL DISEASES
  • CHEMOTHERAPY OF NEOPLASTIC DISEASES
  • DRUGS ACTING ON THE PARASYMPATHETIC NERVOUS SYSTEM (CHOLINERGIC DRUGS)

MODULE 15

  • DRUGS USED IN DERMATOLOGY
  • CARDIAC GLYCOSIDES, ANTIARRHYTHICS AND DRUGS, USED IN ISCHEMIC HEART DISEASE
  • HORMONES, VITAMINS, AND MINERALS.

MODULE 16

  • HYPOTENSIVE DRUGS AND LIPIDS-LOWERING DRUGS
  • OPIOID DRUGS
  • NSAIDs - NONSTEROIDAL ANTIINFLAMMATORY DRUGS

MODULE 17

  • ONCOLOGICAL CLINICAL TRIALS  
  • HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT  (HIPAA)

    Glossary of  Terms

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