CRA Program

ADVANCED ON-LINE CLINICAL RESEARCH ASSOCIATE DIPLOMA

OUR TRAINING PROGRAM IS COMPREHENSIVE AND CONSISTS OF THREE PARTS AS FOLLOWS:

Part One: Fundamentals of Clinical Research

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 Tria
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``

The first part is designed to orient the student to the drug development Process and the clinical research function within the corporate and Regulatory context, from both international and local perspectives.This part is also designed to provide a framework for understanding the standards and regulations that affect the conduct of clinical trials. The course will starts with a historical overview of such documents, Emphasis will be on the International Conference on Harmonization (ICH) guidelines, which will include GCP and reporting of adverse reactions. Additionally, such topics as the Food and Drugs Act and legislation will be discussed. It will outline the various stages of clinical research as they relate to the investigative site. The course will review the progress of a study from an investigator's as well as a sponsor's perspective and highlight the milestones reached throughout the study. Students will learn the management and organizational aspects of site monitoring combined with the quality control measures that ensure the collection of adequate data. It will also guide students through the requirements of effective protocol and case report forms.

Part Two: Anatomy and Physiology for Clinical Research

Session 1: Integumentary System –Human Physiology& Anatomy
Session 2: The Central Nervous System- Human Physiology& Anatomy
Session 3: The Cardiovascular System –Human Physiology& Anatomy
Session 4: Blood- Human Blood Physiology
Session 5: The Respiratory System- Human Physiology& Anatomy
Session 6: The Endocrine System- Human Physiology& Anatomy
Session 7: The Gastrointestinal System-Human Physiology& Anatomy
Session 8: The Urinary System- Human Physiology& Anatomy
Session 9: The Male Reproductive System –Human Physiology& Anatomy
Session 10: The Female Reproductive Sys. –Human Physiology& Anatomy
Session 11: The Muscular System –Human Physiology& Anatomy

The second part is designed to cover the structure and function of the human body with special emphasis on physiological concepts. Students will become familiar with the nervous, endocrine, cardiovascular, respiratory, digestive, urinary and reproduction systems. It will also introduce students to the subject of pathophysiology. The students will study about different diseases, their etiology, epidemiology, symptoms, and other abnormalities associated with these diseases. It enables the graduate to deal with monitoring and management of clinical trials no matter what is the therapeutic area.

Part Three: Soft Skills

Module 1: Time Management Skills
Module 2: Presentation Skills
Module 3: Communication Skills
Module 4: Negotiation Skills
Module 5: Creative Problem Solving Skills

This part is to cover the most important soft skills that is essential to be highlighted in the resume for those who are seeking a career in the clinical research. Soft skills are crucial to land and retain a job.