A cognitive task analysis of clinical data coordinators' validation activity

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Type
Thesis
Author
Lee, Nicole Pao-Mei Chin
Supervisor
Williams, Michael D.
Abstract
Clinical Data Coordinators (CDCs) are primarily responsible for the validation of clinical trials data. This complex cognitive skill involves a high degree of decision-making, requires domain specific knowledge and demands high performance in a high workload environment. The quality of clinical trials data is dependent on the CDCs ability to identify and resolve discrepancies in the data. This paper presents the results of a cognitive task analysis of three experts CDCs in a simulated validation of a recently completed study. The aim is to identify the expert CDCs cognitive structure and skills required for expert performance. This information will be crucial to create instructional solutions to deal with a performance gap of novice CDCs in Singapore. Telephone interviews of three expert CDCs were audio taped as they 'think aloud' when validating three representative case report forms (CRF). Semi-structure interviews using the precursor, action, result and interpretation (PARI) methodology were used to elicit the knowledge and skills utilized by the experts. The expert CDCs have essential knowledge of protocol, database technology, and data handling conventions, which allowed them to, resolved discrepancies quickly and accurately. Mental models of the CRF, Discrepancy Resolution and the interrelationship between the CRF data enabled the expert CDCs to problem solve complex discrepancies. Expert CDCs have an automatic process or steps which they perform during validation. Lastly a set of rules and principles were identified which experts apply automatically. Recommendations for future studies and instructional design are outlined.
Date Issued
2002
Call Number
R853.D37 Lee
Date Submitted
2002