A 2.5-day certification course covering the basics of clinical research & GCP. Ideal for the new or inexperienced and essential for those wishing to attain certification.
No prior experience is required but participants will gain most benefit if they have
worked in the field of clinical research for at least six months prior to
attendance.
At the end of the course participants should have a thorough basic knowledge of
the clinical trial process, be aware of the need to comply with GCP and be aware
of the most important GCP responsibilities.
This course covers and participants will be made aware of
the process of the development of a new medicinal product through the various phases of clinical research (Phases I to IV and PMS)
the types of study undertaken (human pharmacology, therapeutic exploratory, therapeutic confirmatory, therapeutic use)
plain language explanations of abbreviations, methodology and terminology including study designs (parallel group/crossover), blinding methods, use of placebo
introduction of GCP and its implementation by standard operating procedures
the ICH process and products
the clinical trial process from planning to final report and GCP requirements at each stage
role of the biostatistician
subject protection in clinical trials including the role of the Declaration of Helsinki, GCP requirements relating to the consent process and obtaining an ethics committees opinion
safety monitoring and reporting (adverse events, adverse reactions, serious adverse events, expedited reporting, and basic requirements of the ICH E2 guidelines)
investigator's GCP responsibilities
selecting investigators and performing site assessments
pre-study briefings, routine trial monitoring, study closure
data collection and monitoring including source data verification
study documentation including content of the trial master file and archiving
role of quality assurance and consideration of common audit/inspection findings