Archiving Clinical Trial Documents ebook

This monographs aims to help you in improving your archiving policies.

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Presently he is working as Project Manager and working on various therapeutic areas of clinical studies.

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Archive Document Document which must be completed for each clinical study archived. The form contains study details, Investigators details and box contents and details of archivist. A copy should be present in each box archived, with a copy held at the site and the original in the JCTO. The filing system can be in the form of single project file or a number of files/filing cabinets, as deemed most appropriate.

These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. Essential Documents also serve a number of other important purposes

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