Clinical Research INVESTIGATOR Program

 

Session 1	INTRODUCTION: CAREERS IN CLINICAL RESEARCH, Drug Approval Process in the USA and Canada
Session 2	Pharmaceutical Industry Overview
Session 3	Drug Discovery, Development and Research.
Session 4	Pre-clinical Research Pre-Clinical Studies of Drug / Product Candidates
Session 5	Investigational New Drug Application (I.N.D.) in USA  and New Drug Submission (NDS) in Canada
Session 6	Phases of Clinical Trials
Session 7	Good Clinical Practice & International Conference on Harmonization
Session 8	INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
Session 9	CLINICAL TRIAL INVESTIGATOR
Session 10	how to get a trial: selection and monitoring OF CLINICAL INVESTIGATORS
Session 11	Study Initiation
Session 12	Study Monitoring and coordination
Session 13	Recruitment, Retention and Compliance
Session 14	Study CONDUCT AND 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 AND PROTOCOL AMENDMENT (S)
Session 19	CLINICAL TRIAL  INVESTIGATOR'S BROCHURE
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 AND OTHER REGULATORY Requirements
Session 28	Safety Pharmacology Studies for Human Pharmaceuticals
Session 30	Drug Advertising
Final EXAM

 

BONUS PROGRAM:  START PHARMACOLOGY PROGRAM Go to Medical Slides Show

 

Follow this link to Review Samples of Clinical Research Documents

Directory for Frequently Asked Questions (FAQ):

 

Recommended bibliography

GO TO CLINICAL RESEARCH TERMS DICTIONARY 

GO TO MEDICAL TERMINOLOGY

 

• You have to submit the answers to open questions and comments to the articles. In case we will not receive most of them - we would ask you to return to the sessions and submit the answers before we can issue your diploma! 

• Don't forget to indicate your e-mail when you answer the open questions.

• IIn order to receive your diploma, you should pass the final exam at the end of this program.

 

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