File Details
Essential Documentation in Clinical Trials | |
File name | Essential Documentation in Clinical Trials |
File Description | Essential documentation serves to demonstrate the compliance of the investigator, sponsor and monitor, and IRB with the standards of GCP, Best Practice, and all applicable regulatory requirements.Clinical trials are sets of tests in medical research and drug development that generate safety and efficacy data (or more specifically, information about adverse drug reactions and adverse effects of other treatments) for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). They are conducted only after satisfactory information has been gathered on the quality of the nonclinical safety, and health authority/ethics committee approval is granted in the country where approval of the drug or device is sought. |
Category Name | Medicine |
Subject Name | Clinical Research |
Module Name | Clinical Trials |
Micro Category Name | -- |
Level | Bachleors |
File Type | Video |
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