Specific aspects of source medical documents in clinical studies on healthy volunteers
This article covers important aspect of methodology of clinical trials - source medical documents. Special attention is always paid to source medical records in phase 1 trials when the future of novel medicinal product is at stake. Authors discuss some issues of development and application of trial-...
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| Main Authors: | , , |
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| Format: | Book |
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Izdatelstvo OKI,
2018-05-01T00:00:00Z.
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| Online Access: | Connect to this object online. |
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| Summary: | This article covers important aspect of methodology of clinical trials - source medical documents. Special attention is always paid to source medical records in phase 1 trials when the future of novel medicinal product is at stake. Authors discuss some issues of development and application of trial-specific forms as part of source medical documentation on the basis of practical experience in conducting phase 1 studies on healthy volunteers. Primary focus is on the structure and content of these forms with respect to specific procedures and study population in early phase research. Authors believe that implementation of trial-specific forms improves the quality of clinical trials. |
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| Item Description: | 2588-0519 2618-8473 |