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.

Skills Needed

• To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.
• No previous data management experience is necessary although familiarity with Microsoft Excel is required.

Learning Outcomes

At the conclusion of the course, you should be able to

• List the common tasks undertaken as part of clinical data management.
• Understand the details and variations associated with each of those tasks.
• Write a data transfer specification for collecting lab data.
• Write a quality specification and query message for cleaning Case Report Form (CRF) data.
• Define the deliverables and responsibilities when working with Contract Research Organizations (CRO).
• Write a data management plan.

Topics Include

• 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

Notes

Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.