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• An NTF documenting that the patient was not consented prior to study procedures is signed by the clinical research coordinator and is placed in the subject’s study file. First, the NTF content is not valuable when it simply points out the error. To be valuable documentation, the NTF should also include why this happened, the actions that were taken/will be taken to address the deficiency, the steps that will be taken to prevent this situation from recurring, and how the effectiveness of the intervention will be evaluated.[/color]
Started by PCR
Clinical Investigator Site Staff
Started by mukul
Started by mejaveed.82
Ethical Concerns in Clinical Research