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Siebel Life Sciences Guide
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Regulatory Reporting
This chapter covers the following topics:
About Regulatory Reporting
About Regulatory Reports
Scenario for Regulatory Reporting
Process of Regulatory Reporting
Setting Up Report Numbers
Creating and Populating New Regulatory Reports
Entering and Reviewing Data for 3500A Reports
Entering and Reviewing Data for MDV Reports
Running 3500A and MDV Reports
Which Sections of the MedWatch 3500A Form Are Filled In?
Generating Regulatory Report Numbers and Submitting Reports
Transmitting Electronic Medical Device Reporting Immediately
Managing Batch Electronic Medical Device Reporting
Reopening a Regulatory Report
Creating Supplemental or Follow-Up Regulatory Reports
Field Mapping for the MedWatch Report
Field Mapping for the MDV Report
About Configuring Buttons in Regulatory Reports
Siebel Life Sciences Guide
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