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The accompanying manual describes the set up and ongoing use of these tracking tools.
Tracking Spreadsheet (xls spreadsheet)
Tracking Spreadsheet manual (word doc)
Safety Reporting Flowchart (ppt)
A flowchart representing the decision tree for determining the minimum required expedited reporting of adverse events to the FDA for IND studies.
Site FDA Audit Checklist (xls spreadsheet)
An example of a checklist for clinical study site preparation for an FDA audit.
Study Budget Template (xls spreadsheet)
A template that can be used to create industry sponsored clinical trial budgets.
Study Management Checklist (word doc)
An example of a checklist of tasks required for the management of a clinical study...
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