The many regulatory agencies charged with oversight of Clinical Research have exacting requirements to ensure the protection of study participants; and while there is overlap in goals there are differences in expectations and standards. The complex regulatory environment can be difficult to navigate, but understanding it is a necessity for all clinical research professionals. Compliance with all of the various regulatory requirements ensures safety of patients, quality of data and timeliness and efficiency of study completion.
Learning Objectives:
Differentiate between the regulations that apply to FDA-regulated studies and those that apply to federally- funded studies
Define research with human subjects
Describe the typical activities and flow of a study
Describe different types of human subjects research
Define research misconduct
Describe the standard items addressed in a clinical trial agreement (CTA)
Describe Conflict of Interest (COI)
Identify key components of good documentation practices
Who will Benefit:
Healthcare providers interested in exploring the field of Clinical Research
New Clinical Research Coordinators (1-2 years)
New Principal Investigators
Administrative managers in charge of Clinical Research
Note:
Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2016.
For Registration:
http://www.complianceonline.com/conducting-clinical-trials-seminar-training-80322SEM-prdsm?channel=sciencedz