GlobalVigiPub provides you the free online pharmacovigilance training via the posts page on our website. This Guidance on drug safety is good enough to understand the Pharmacovigilance basics and get the roots of pharmacovigilance in detailed too. Just browse the posts and read to get the knowledge on Pharmacovigilance course
SRP (Safety Reporting Portal) inner view
SRP home page appears as below. Page shows options for Create account, login
Readers Note: Controlling of high Blood Pressure. Is it possible? Yes it is possible with this easy and simple style
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Once User login, the page appears as below snap
Readers Note: Let us get a trail version for the renal problems with the Kidney Disease Solution
Please click on Start New Report tab to begin the data entry in portal for reporting to US FDA. Once user click on the tab, it takes you to the Data Entry Page as below
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Reporter Information: Data Entry starts here with the filling of respective details from the case report document (Source document). The below snap tells about filling of Reporter Information
Click on Add section in the Reporter Information to create a page for reporter. User can add many reporters in the case by clicking Add. The Reporter page appears as below
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Patient Information: Once done with Reporter details, then user can click on Patient Information tab to add the patient details. The Patient page appears as below
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Medical History: Patient tab also has Medical History section on bottom. By clicking Add, user can add the Patient medical history and current conditions. That page appears as below
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Adverse Event: Once done with Patient tab, then click on Adverse Event tab to enter the Event details of Case. The page appears as below
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Click on Add to create a page for Adverse event. Page appears as below
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Primary Suspect Product: Once done with Adverse event section, user fill Primary suspect Product details. The Products of Pharmaceutical company need to be imbibed in SRP while Account registration. The Product tab appears as below
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Device Component: If Pharmaceutical company has devices also been launched in Market. then the devise related complaints or events need to be filled in Device Component Section
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Other Products: User can add all other products such as concomitant medications or historical drugs reported in case report in Other Products Section. That section appears as below
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Attachments: Once done with all the information, user need to attach the case report in PDF format in Attachments section. Click on the section and page appears as below. User can attach all relevant documents by clicking Add option.
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Submission: Once done with all the data entry, user can submit the report. Click on Submit Report to report the case to FDA. Once Submission is done, then it takes you to My reports section as below snap
User can view PDF of that submitted report as below
Once case is submitted in Portal as per above explanation, user will be receiving an e-mail notification about the receipt of submission