Course Overview
Clinical Data Management Program + GCP, GDMP Certificate - CRI002
Electronic data capture (EDC) and clinical trial information management systems have made an enormous leap forward in their ability to adapt to effectively meet the challenges in today’s dynamic clinical trial environment. Clinical tests are becoming increasingly complex to support growth in the number of new drug molecules entering the clinical trials each year. Approval of the new molecular entities by the regulatory bodies relies heavily on collecting patient data from trial sites. Such complex environments drive the need for trained professionals. To meet this growing need, Clinwell is offering comprehensive training in the cutting-edge technologies of clinical data management. The training is designed to support the entire study lifecycle from business analysis to online data entry, GCDMP and FDA compliant clinical trial database management systems.
The goal of Clinical Research Associate program offered by Clinwell is to develop and train professionals to understand and navigate an array of regulations and policies that pertain to conducting, monitoring and managing clinical trials. The program covers various aspects of a clinical trial from site selection, patient recruitment, choice of the investigator, study conduct, protocols, safety documentations, and study close out. In addition, the program is designed to cover international regulations. Our students learn from some of the best faculty in the industry who are certified practitioners with deep experience in clinical trials and monitoring and have a wide knowledge of ICH-GCP, GMP, GLP and HIPAA.
Chapter 1 |
introduction: Careers in clinical research, drug approval process in the USA and Canada |
Chapter 2 |
Pharmaceutical industry overview |
Chapter 3 |
Start clinical research process: drug discovery, drug research. |
Chapter 4 |
Pre-clinical research pre-clinical studies of drug / product candidates |
Chapter 5 |
Investigational new drug application (I.N.D.) in usa and new drug submission (NDS) in canada |
Chapter 6 |
Phases of clinical trials |
Chapter 7 |
Good clinical practice & international conference on harmonization |
Chapter 8 |
Institutional review board/independent ethics committee (IRB/IEC) |
Chapter 9 |
Clinical trial investigator |
Chapter 10 |
How to get a trial: Selection and monitoring of clinical investigators |
Chapter 11 |
Study initiation |
Chapter 12 |
Study monitoring and coordination |
Chapter 13 |
Recruitment, retention and compliance |
Chapter 14 |
Study conduct and closeout |
Chapter 15 |
Computerized systems used in clinical trials |
Chapter 16 |
Choice of control group in clinical trials |
Chapter 17 |
Clinical trial sponsor |
Chapter 18 |
Clinical trial protocol and protocol amendment (S) |
Chapter 19 |
Clinical trial investigator's brochure |
Chapter 20 |
Essential documents for the conduct of a clinical trial |
Chapter 21 |
Adverse reactions in clinical trials |
Chapter 22 |
Informed consent |
Chapter 23 |
Safety in clinical trials |
Chapter 24 |
Medical dictionary for regulatory activities (MedDRA) |
Chapter 25 |
Inspection strategy for clinical trials |
Chapter 26 |
Avoiding fraud in clinical trials |
Chapter 27 |
Financial disclosure by clinical investigators and other regulatory requirements |
Chapter 28 |
Safety pharmacology studies for human pharmaceuticals |
Chapter 29 |
Recruitment of volunteers for clinical trial |
Chapter 30 |
Drug advertising |
Chapter 31 |
Health insurance portability and accountability act (HIPAA) |
