This course is designed to assist clinical trials sponsors to design data
capture methods, and to organize and manage clinical trial data collected
from one or more investigative sites. Topics include data flow from site
to sponsor; case report form (CRF) design, database structures; database
management systems including validation, backup, security and electronic
data capture (EDC) systems; data capture techniques, data transfer and
uploads; data quality methods including data entry, data review and
programmatic checking, CRF-to-database audit procedures; analysis-ready
database procedures; patient confidentiality; and ICH Guidelines (21 CFR
Other Credits: BRN: 16 CE hours.
Course Number: FPM-40218
Credit: 2.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management
There are no sections of this course currently scheduled. Please contact the Healthcare & Behavioral Sciences department at 858-534-9262 or email@example.com for information about when this course will be offered again.