Online Safety Community

The FDA’s Adverse Event Reporting Requirements

The FDA's Adverse Event Reporting Requirements5.jpg

The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action.

The adverse event reporting system may be understood as being a database that aids and supplements the FDA’s postmarketing surveillance program for all its approved products that fall in the category of therapeutic biologics and drugs. So, this database has a record of the adverse event reporting done by all individual and sponsors of their clinical trials. It is a catalog of all the error reports that get generated at various times and stages of the clinical research program.

Voluntary in nature

The FDA's Adverse Event Reporting Requirements4

The outstanding aspect of the FDA’s adverse event reporting requirements is that these reporting requirements are not mandatory. Yet, those involved in clinical research, such as sponsors, healthcare and pharmaceutical organizations, institutions and individuals strictly adhere to adverse event reporting requirements in order to steer clear of legal entanglements that could come their way in the future, and to help other players keep track of all adverse events.

Some of the core adverse event reporting requirements

The FDA's Adverse Event Reporting Requirements1

Applicants should electronically submit all Individual Case Safety Reports (ICSRs) for human drug and nonvaccine biologic products in xml format. Among the adverse event reporting requirements, this has been in place from 2000.

The FDA has been amending rules relating to adverse event reporting requirements from time to time. According to the amendment passed in June 2015; the following adverse event reporting requirements apply:

All applicants should submit all ICSRs, ICSR attachments, and periodic safety reports electronically. They can do this using either of these options:

The E2B method specifies that the files should be in xml format, and the attachments in pdf.

The FDA's Adverse Event Reporting Requirements3

The Safety Reporting Portal (SRP) is meant for those applicants that do not have the database-to-database capability. To fulfill this among the FDA’s adverse event reporting requirements, the applicant needs to have an account with which to access the portal site. FDA’s adverse event reporting requirements state modes and criteria that applicants have to meet to request an SRP account, to activate the account, to add attachments, and for submitting Periodic Safety Reports (PSR).

click to continue reading

Views: 18

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Training Doyens posted events
Friday
Soujanya Naganuri posted a discussion

Flow of SAP MM and SUS Portal

SAP Material Management (MM) and SAP Supplier Self Service (SUS) and some customizable features of SAP SUS.In the Plan-Driven Procurement with Supplier Integration scenario the SAP SUS is installed and configured with SAP MM/SRM. Technically, in a classic scenario SAP SUS maybe connected with one or more MM and/or SRM back-end systems.PO is sent to SAP SUS system, in which supplier can perform the follow-on procurement process, i.e. PO response, ASN, GR response and invoice response.SAP…See More
Thursday
John Robinson posted blog posts
Thursday
Emma Miah posted a blog post

Latest Men’s Fashion Trends For Winter

Most people will agree that fashion trends use to fade, but the style is the one thing that is eternal. So, it’s always suggested that you should only follow the fashion trends that actually suits your personality. Winter is coming now it’s time to…See More
Thursday

Forum

Flow of SAP MM and SUS Portal

SAP Material Management (MM) and SAP Supplier Self Service (SUS) and some customizable features of SAP SUS.In the Plan-Driven Procurement with Supplier Integration scenario the SAP SUS is installed…Continue

Tags: sapmmcourse, sapmmonline, sapmm

Started by Soujanya Naganuri on Thursday.

PEGA Axis error: Parser already accessed

We have a PEGA frontend, from in which we're keying in double byte characters like japanese and being send to allotted java webservice through axis. this is working best when we ship singlebyte…Continue

Tags: pega_training, pega_online, pega

Started by Soujanya Naganuri Dec 6.

VMware player error on install vmware tools.

 I've installed the last version of VMware player (4.0.2) and created a virtual machine with ubuntu 10.04. However, some operations with …Continue

Tags: training, online, vmware

Started by emmablisa Dec 1.

All About QlikView

QlikViewQlik relies on sophisticated analytics that enables data discovery using an in-memory engine to analyze data for patterns not visible via SQL data structures or queries. The company’s two…Continue

Tags: Safety, Qlikview

Started by nicolewells Nov 25.

Occupational Health and Safety 5 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tara safe Nov 16.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service