Course Overview
Quality Assurance Program + GCP, GMP, GLP Certificates - CRI003
The Quality Assurance (QA) function plays a vital role in checking each stage of a clinical trial process and managing data systems after clinical monitoring. Increasing number of clinical trials, electronic data-processing, more participation of volunteers in clinical trials and global expansion of Good Clinical Practice into newer areas have resulted in growing need for QA professionals.
To meet this growing need, Clinwell offers Quality Assurance Program that offers detailed training into understanding the quality standards during a clinical trial. The program begins with understanding of drug discovery process, preclinical research, basic understanding of disease and progresses to cover various aspects of data base design, data acquisition through case report forms, data entry, data validation, data processing and database closure.
Chapter 1 |
Introduction: Careers in clinical research, drug approval process in the USA and Canada |
Chapter 2 |
Data definition, forms, and database design in clinical trials |
Chapter3 |
Data acquisition |
Chapter4 |
CRF printing and vendor selection |
Chapter5 |
CDM presentation at investigator meetings |
Chapter6 |
Data storage |
Chapter7 |
Computers in clinical trials: hardware, operating systems, and database management systems. |
Chapter8 |
Database validation, programming and standards |
Chapter9 |
Data entry and data processing |
Chapter10 |
Laboratory and other external data |
Chapter11 |
Safety data management and reporting |
Chapter12 |
Data entry and distributed computing |
Chapter13 |
Measuring data quality |
Chapter14 |
Assuring data quality |
Chapter15 |
Database closure |
Chapter16 |
Training of clinical data management (CDM) employees |
Chapter17 |
Clinical trial patient registration |
Chapter18 |
Central quality control of data in clinical trials |
Chapter19 |
Software tools for trials management: sas. Oracle clinical, clintrial |
Chapter20 |
Health insurance portability and accountability act (HIPAA) |
Chapter21 |
Pharmaceutical industry overview |
Chapter22 |
Start clinical research process: drug discovery |
Chapter23 |
Pre-clinical researcher-clinical studies of drug / product candidates |
Chapter24 |
Investigational new drug application (I.N.D.) in USA and New Drug Submission (NDS) in Canada |
Chapter25 |
Phases of clinical trials |
Chapter26 |
Good clinical practice & international conference on harmonization |
Chapter27 |
Institutional review board/independent ethics committee (IRB/IEC) |
Chapter28 |
Clinical trial investigator |
Chapter29 |
Monitoring of clinical investigations |
Chapter30 |
Regulations for computerized systems used in clinical trials |
Chapter31 |
Choice of control group in clinical trials |
Chapter32 |
Clinical trial protocol and protocol amendment (s) |
Chapter33 |
Clinical trial investigator's brochure |
Chapter34 |
Essential documents for the conduct of a clinical trial |
Chapter35 |
Adverse reactions in clinical trials |
Chapter36 |
Informed consent |
Chapter37 |
Safety in clinical trials |
Chapter38 |
Medical dictionary for regulatory activities (MEDDRA) |
Chapter39 |
Auditing & inspection strategy for clinical trials and vendor management |
Chapter40 |
Avoiding fraud in clinical trials |
Chapter41 |
Financial disclosure by clinical investigators |
Chapter42 |
Safety pharmacology studies for human pharmaceuticals |
Chapter43 |
Safety data reconciliation (sae data reconciliation) |
Chapter44 |
Drug advertising |
Chapter45 |
Bioanalytical method validation |
Chapter46 |
Data management jobs description |
Chapter47 |
Introduction to six sigma |
Chapter48 |
General principles of pharmacology |
Chapter49 |
Principles of pharma co dynamics, transduction and neurotransmission |
Chapter50 |
Kinetic principles of drug administration (Pharmacokinetic) |
Chapter51 |
Drug interactions and metabolism |
Chapter52 |
Drugs acting on the sympathetic nervous system (Adrenergic Drugs) |
Chapter53 |
Antibiotics |
Chapter54 |
Drugs affecting the coagulation system |
Chapter55 |
Drugs used in treatment of allergies |
Chapter56 |
Treatment of central nervous system degenerative disorders |
Chapter57 |
Drugs for the treatment of viral diseases |
Chapter58 |
Chemotherapy of neoplastic diseases |
Chapter59 |
Drugs acting on the parasympathetic nervous system (Cholinergic Drugs) |
Chapter60 |
Drugs used in dermatology |
Chapter61 |
Cardiac glycosides, antiarrhythics and drugs, used in ischemic heart disease |
Chapter62 |
Hormones, vitamins, and minerals. |
Chapter63 |
Hypertensive drugs and lipids-lowering drugs |
Chapter64 |
Opioid drugs |
Chapter65 |
nsaids - no steroidal anti-inflammatory drugs |
