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Training & Education   Course outline
Course Outline:
Session 1:

The Clinical Research Industry –Overview

Session 2:

Pharmaceutical Industry Overview

Session 3:

Clinical Pharmacology –Primary Aspects

Session 4:

The use of Animals in Clinical Research

Session 5:

Drug Discovery Process

Session 6:

Testing Medical Products in People; Phases of Clinical Trials

Session 7:

The New Drug Approval Process

Session 8:

Investigational New Drug and New Drug Application

Session 9:

History of Food and Drug Regulations

Session 10:

Milestones in U.S Food and Drug Law History

Session 11:

Enforcement of The Food, Drug and Cosmetic Act

Session 12:

Principles of GCP ICH

Session 13:

Institutional Review Board

Session 14:

Clinical Research Investigators

Session 15:

Clinical Trials Sponsor

Session 16:

Clinical Trial Protocol

Session 17:

Clinical Trial Investigator’s Brochure

Session 18:

Essential Documents for The Conduct of a Clinical Trial

Session 19:

Informed Consent; Requirements and The Consent Process

Session 20:

Study Subjects Recruitment

Session 21:

Monitoring of Clinical Investigations

Session 22:

Clinical Study Initiation

Session 23:

Clinical Study Monitoring

Session 24:

Study Closeout

Session 25:

Choice of Control Group in Clinical Trials

Session 26:

Computerized Systems Used in Clinical Trials

Session 27:

Safety in Clinical Trials

Session 28:

Adverse Reactions in Clinical Trials

Session 29:

MedDRA (Medical Dictionary for Regulatory Activities)

Session 30:

Fraudulent Data in Clinical Trials

Session 31:

Scientific Misconduct and Avoiding Fraud in Clinical Trials

Session 32:

Preparing for Clinical Trial Audits and FDA Inspections

Session 33:

Genomic and Targeted Medicine

Session 34:

Improving Critical Path Initiative

Session 35:

Medical Devices and [510(K)] Submission

Session 36:

Financial Disclosures By Clinical Investigators

Session 37:

Drug Advertising Directly to Consumers- Regulations

Session 38:

Bioethics in Clinical Research

Session 39:

HIPAA “Health Insurance Portability and Accountability Act``


FINAL EXAM: 100 Multiple Choice Questions “Passing Score is 70%”






























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Clinical Research Associate Training Program