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Patient medical data,
patient research data, and the clinical research protocol
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to start Module 2 (External URL)
Author(s): Clinical Research
Education, St. Jude Children's Research
Hospital
Publication Date: 06 Aug,
2004
Abstract: Learning Objectives for Module 2
1. To differentiate between routine clinical/medical
data collection and research data collection.
2. To
define “data integrity” and state its importance.
3.
To determine tests and procedures outlined in a clinical
research protocol.
4. To search the protocol and
determine specific study data to be obtained and recorded.
5. To be able to access the research protocol, know
how to read the protocol, and how to find key information.
6. To differentiate between incident reporting,
adverse event reporting, serious adverse events, toxicities,
and unusual events/behaviors.
7. To define the
clinical record, the research record, source documentation
and to differentiate among them.
8. To verbalize how
clinically obtained medical data becomes a part of the
research record and how that data is utilized for scientific
analysis and scientific reporting.
9. To understand
the role of clinical staff in recording data that will be
utilized in a research study and become part of the research
record. To verbalize the clinical staff role in the research
process.
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