Method
Flexible
Term
FALL
Units
2.0 QUARTER UNITS
Estimated Cost
$785

Skills you will gain

  • Clinical Data Workflow: Understanding of the process from data collection to analysis.
  • Data Quality Assurance: Techniques for cleaning and validating clinical trial data.
  • Data Management Planning: Development of detailed plans for data operations.
  • CRO Collaboration: Definition of roles and deliverables in outsourced trials.
  • Specification Writing: Drafting of data transfer and quality documentation.

Course Description


High-quality clinical data are at the heart of a successful clinical trial. If the data are not complete or do not reflect the actual reported results, the analysis and the conclusions drawn from that analysis may not be reliable. This course provides clinical trial personnel a solid understanding of the steps involved in clinical data management from study site data collection through data extraction for analysis.

Topics

  • A planned approach to clinical data management
  • Basic design and specification of the database and cleaning rules
  • Required documentation, standard operating procedures (SOPs), and quality control
  • Compliance with FDA/ICH guidelines
  • Working with other clinical groups and external contract research organizations (CROs)
  • Using electronic data capture (EDC)
  • Data security and confidentiality

Professional Credit

UCSC EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 20 contact hours

Syllabus Library
Currently no classes scheduled. Would you like to be notified when a class is available?

This course applies to these programs:

Demo