| Autor: |
McCue, Jane, Brady, Priscilla, Benotti, Joseph |
| Zdroj: |
Clinical Research and Regulatory Affairs; 1984, Vol. 2 Issue: 1 p27-44, 18p |
| Abstrakt: |
The role of the nurse in clinical drug trials is evolving into a specialty with the responsibilities becoming increasingly more complex. The clinical research nurse (CRN) requires more definitive guidelines regarding the legal responsibilities of the position. The focus of this article is on the regulations of the Food and Drug Administration (FDA) and its practical implications for the nurse participating in clinical trials. The discussion will encompass compliance according to the FDA regulations governing pre-trial preparation, data acquisition and reporting, obligations after completion of the investigation and the regulatory check list that we have found useful in preparing for an FDA audit. |
| Databáze: |
Supplemental Index |
| Externí odkaz: |
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