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About Regulatory Reports
From the time an adverse event or complaint is confirmed as reportable, companies generally have less than 30 days to report to a regulatory agency. An adverse event or complaint can be verified as reportable at various stages of the AECM process, from the initial customer call through to the review of the findings by the analysis team. Companies usually follow certain assessments that determine if an adverse event or complaint is reportable or not. Separate reports have to be filed for each product that malfunctioned or caused the adverse event. Reports filed are based on the product issue, which typically contains much of the needed information. After the initial report, companies generally file additional supplemental, summary, and annual reports to update information on the investigation and resolution process. The preconfigured Siebel AECM module supports MedWatch and MDV reports:
About Report Types
There are four regulatory reports that can be created in Siebel AECM.
Table 45. Report Types in Siebel AECM
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Data for the Report Is Taken from These Views in the Regulatory Reports Screen |
3500A |
For initial mandatory reports to MedWatch (FDA). |
- More Info
- Patient
- Importer (if the Facility Type field in the Importer view is not blank)
- Manufacturer and Investigation (if the Facility Type field in the Importer view is blank)
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3500A Supplemental |
For additional information to MedWatch after initial reports have been submitted. |
MDV Initial |
For initial reports to NCAs who accept MDV forms forms. |
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MDV Follow-up |
For additional information to NCAs after initial reports have been submitted. |
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