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3 Cards in this Set
- Front
- Back
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Essential Documents are those documents which individually and collectively permit evaluation of the ___ of a trial and the ___ of the data produced.
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conduct
quality |
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Essential documents serve to demonstrate the ___ of the investigator, sponsor and monitor with the standards of __ __ __ and with all applicable ___requirements.
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compliance
Good Clinical Practice regulatory |
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Some examples of essential documents include ___, __, __ but there are loads of other documents
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Investigator Brochure, signed protocol amendements, and signed informed consent forms.
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