ICH E6 Guideline for Good Clinical Practice
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What are essential documents
documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced
What do essentail documents demonstrate
they serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP adn with all applicable requirements
Essential documents serve what other purpose
- they assist in the management of a trial by the investigator, sponsor and monitor
- they are usually audited by and independent auditor and inspected by regulatory authorities to confirm the validity of the trial and integrity of the data
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