| 3 |
Role of the clinical staff
member in collecting and recording patient research data
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to start Module 3
Author(s): Clinical Research
Education, St. Jude Children's Research
Hospital
Abstract: Learning Objectives for Module
3
1. To describe the pertinent Federal regulations,
International Conference on Harmonization Good Clinical
Practices (pertaining to research), and other established
standards for clinical research data collection, storage,
management, and analysis.
2. To describe the
definitions of “adverse events” and “serious adverse
events”.
3. To outline the reporting requirements
for data collection and reporting for adverse events and
serious adverse events.
4. To verbalize how research
data is monitored and audited for accuracy, completeness and
integrity.
5. To explain the impact of the clinical
staff member on research data, and how incorrect or
incomplete data comprises data integrity and compromises the
quality of the scientific investigation.
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