KRC

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DATA MANAGEMENT IN CLINICAL TRIALS,

 GOOD CLINICAL PRACTICE 

ON-LINE PROGRAM

Welcome to KRC Inc. Interactive On-line training!

 

Session 1	INTRODUCTION: CAREERS IN CLINICAL RESEARCH, Drug Approval Process in the USA and Canada
Session 2	Data Definition, Forms, and Database Design IN CLINICAL TRIALS
Session 3	Data Acquisition
Session 4	CRF Printing and Vendor Selection
Session 5	CDM Presentation at Investigator Meetings
Session 6	Data Storage
Session 7	Computers in Clinical Trials: Hardware, Operating Systems, and Database Management Systems.
Session 8	Database Validation, Programming and Standards
Session 9	Data Entry and Data Processing
Session 10	Laboratory and Other External Data
Session 11	Safety Data Management and Reporting
Session 12	Data Entry and Distributed Computing
Session 13	Measuring Data Quality
Session 14	Assuring Data Quality
Session 15	Database Closure
Session 16	Training of Clinical Data Management (CDM) Employees
Session 17	clinical trial Patient Registration
Session 18	Central Quality Control of Data  in clinical Trials
Session 19	Software Tools for Trials Management:  sas. oRACLE cLINICAL, clintrial
Session 20	HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT  (HIPAA)
Session 21	Pharmaceutical Industry Overview
Session 22	Start Clinical Research Process: Drug Discovery,
Session 23	Pre-clinical ResearchPre-Clinical Studies of Drug / Product Candidates
Session 24	Investigational New Drug Application (I.N.D.) in USA  and New Drug Submission (NDS) in Canada
Session 25	Phases of Clinical Trials
Session 26	Good Clinical Practice & International Conference on Harmonisation
Session 27	INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
Session 28	CLINICAL TRIAL INVESTIGATOR
Session 29	MONITORING OF CLINICAL INVESTIGATIONS
Session 30	regulations for COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS
Session 31	Choice of Control Group in Clinical Trials
Session 32	CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT (S)
Session 33	CLINICAL TRIAL  INVESTIGATOR'S BROCHURE
Session 34	ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL
Session 35	ADVERSE REACTIONS IN CLINICAL TRIALS
Session 36	INFORMED CONSENT
Session 37	SAFETY IN CLINICAL TRIALS
Session 38	Medical Dictionary for Regulatory Activities (MedDRA)
Session 39	auditing & inspection strategy for clinical trials and Vendor Management
Session 40	Avoiding Fraud in Clinical Trials
Session 41	Financial Disclosure by Clinical Investigators
Session 42	Safety Pharmacology Studies for Human Pharmaceuticals
Session 43	SAFETY DATA RECONCILIATION (SAE DATA RECONCILIATION)
Session 44	Drug Advertising
Session 45	Bioanalytical Method Validation
Session 46	DATA MANAGEMENT JOBS DESCRIPTION
Session 47	Introduction to Six Sigma

Session 48	GENERAL PRINCIPLES OF PHARMACOLOGY
Session 49	PRINCIPLES OF PHARMACODYNAMICS, TRANSDUCTION AND NEUROTRANSMISSION
Session 50	KINETIC PRINCIPLES OF DRUG ADMINISTRATION (Pharmacokinetic)
Session 51	DRUG INTERACTIONS AND METABOLISM
Session 52	DRUGS ACTING ON THE SYMPATHETIC NERVOUS SYSTEM (ADRENERGIC DRUGS)
Session 53	ANTIBIOTICS
Session 54	DRUGS AFFECTING THE COAGULATION SYSTEM
Session 55	DRUGS USED IN TREATMENT OF ALLERGIES
Session 56	TREATMENT OF CENTRAL NERVOUS SYSTEM DEGENERATIVE DISORDERS
Session 57	DRUGS FOR THE TREATMENT OF VIRAL DISEASES
Session 58	CHEMOTHERAPY OF NEOPLASTIC DISEASES
Session 59	DRUGS ACTING ON THE PARASYMPATHETIC NERVOUS SYSTEM (CHOLINERGIC DRUGS)
Session 60	DRUGS USED IN DERMATOLOGY
Session 61	CARDIAC GLYCOSIDES, ANTIARRHYTHICS AND DRUGS, USED IN ISCHEMIC HEART DISEASE
Session 62	HORMONES, VITAMINS, AND MINERALS.
Session 63	HYPOTENSIVE DRUGS AND LIPIDS-LOWERING DRUGS
Session 64	OPIOID DRUGS
Session 65	NSAIDs - NONSTEROIDAL ANTIINFLAMMATORY DRUGS

PROJECT I	Efficacy of the lowering effect of PROLIPOSTAT® on Blood concentrations of low-density lipoprotein cholesterol (LDL-C) in patients with normal and elevated blood concentrations of LDL-C
PROJECT II	Phase II Study the Efficacy of the healing effect of recombinant human epidermal growth factor (rhEGF) on diabetic foot ulcers
PROJECT III	Phase I Study the safety and Dose determination of Immuno - Stimulatory Therapy Agent for Bladder cancer, melanoma and colon cancer.
PROJECT IV	Survey: Proper Use and Cost Reduction strategies for prescription and non-prescription drugs
Final EXAM

 

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Click HERE for Abbreviations and Acronyms

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• You must complete all of the sessions before attempting the final exam.  You must answer all of the questions at the end of each session in order to complete this course.  We must receive all completed course materials before we can issue your diploma! 

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

• IN ORDER TO RECEIVE DIPLOMA YOU MUST PASS THE FINAL EXAM AT THE END OF THIS PROGRAM.

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